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<ul><li>About The Role</li><li>Are you a strategic leader with a passion for safeguarding patient safety, regulatory compliance, and operational resilience within the pharmaceutical industry? Do you have the expertise to drive risk and compliance programs that protect assets, uphold reputation, and support long-term success? If so, we have the perfect opportunity for you! Role Overview As a Risk Manager, you will lead LloydsClinical's comprehensive risk and compliance program, ensuring the organisation's assets, reputation, and patient safety are safeguarded. You will be responsible for identifying, assessing, and mitigating risks across all business areas, including regulatory compliance, drug safety, and supply chain management. By fostering transparency and accountability, you will strengthen LloydsClinical's resilience and support its commitment to ethical integrity. Key Responsibilities: <ul> <li> Risk Management Frameworks: Design, implement, and oversee a robust framework to identify, evaluate, and manage risks across LloydsClinical's sites. </li> <li> Risk Assessment Matrix: Develop and maintain risk assessment tools to prioritize and address risks based on qualitative and quantitative analysis. </li> <li> Comprehensive Risk Plans: Create detailed Risk Management Plans (RMPs) targeting regulatory compliance, pharmacovigilance, patient safety, and operational risks. </li> <li> Governance and Compliance Strategy: Establish and maintain corporate governance strategies to ensure adherence to legal, regulatory, and best practice standards. </li> <li> Collaboration and Stakeholder Engagement: Work closely with internal teams, regulatory bodies, and external partners to align risk initiatives and ensure compliance. </li> <li> Training and Capability Building: Design and deliver training programs that enhance risk management capabilities across all LloydsClinical's sites. </li> </ul>Why Lloyds Clinical? We have a lot to offer to not only the 100,000 patients we support, but also to our valued employees. Lloyds Clinical has a wide range of exciting opportunities for passionate professionals across nursing, patient services, compounding, pharmacy and warehousing. These roles come with fantastic benefits including: <ul> <li> 25 days annual leave plus bank holidays </li> <li> Company bonus scheme </li> <li> Outstanding training &amp; development programmes </li> <li> Up to £1200 refer a friend bonus </li> <li> Full support from our employee assistance programme including a health and well-being app </li> <li> Savings and discounts at multiple retailers through our rewards portal </li> </ul></li><li>About You</li><li>A successful candidate will demonstrate the following skills and experience: <ul> <li> Corporate Governance Expertise: Experience in leading corporate governance initiatives and ensuring compliance with regulatory frameworks at a strategic level. </li> <li> Risk Register Management: Proven ability to manage and maintain a company's risk register, identifying and mitigating risks to protect the business. </li> <li> Track Record in Risk Reduction: Proven track record in leading risk reduction efforts and implementing strategies to minimize organizational exposure. </li> <li> Healthcare Experience (Preferred): Familiarity with the healthcare sector and its regulatory challenges is a significant advantage. </li> <li> Risk Knowledge: Expertise in risk management plans (RMPs), identifying and mitigating risks. </li> <li> Knowledge of UK Pharmaceutical Regulations: Strong understanding of UK pharmaceutical regulations. </li> <li> Professional Risk Qualification: Holding a professional risk qualification. </li> <li> ICSA Membership: Chartered Governance Institute membership or Level 3 qualification from the Institute of Risk Management. </li> <li> Professional PM Qualifications: Holding professional project management qualifications. </li> <li> Corporate Governance Frameworks: Strong knowledge of corporate governance frameworks, legal, and finance knowledge. </li> <li> Board-Level Experience: Experience in managing board-level corporate governance activities and stakeholder relationships. </li> <li> Audit Familiarity: Familiarity with conducting internal and external audits. </li> </ul>If you are a proactive, strategic thinker with a passion for risk management and corporate governance, we invite you to apply and contribute to our continued success in a dynamic and evolving industry. Skills and Expertise <ul> <li> Extensive experience in risk management within the pharmaceutical, healthcare, or biotech industries. </li> <li> Strong knowledge of regulatory frameworks such as MHRA, GMP, GCP, and GDPR. </li> <li> Exceptional analytical, organizational, and communication skills. </li> <li> Ability to devise effective risk mitigation strategies and lead cross-functional teams. </li> </ul>Knowledge and Qualifications <ul> <li> A degree in Life Sciences, Risk Management, or a related field. </li> <li> Certifications such as IRM, ISO 31000, or relevant governance qualifications (e.g., ICSA membership). </li> <li> Proficiency in corporate governance frameworks and compliance standards. </li> </ul></li><li>About Us</li><li><ul> <li>At Lloyds Clinical, with over four decades of experience supporting patients since 1975, we are dedicated to delivering exceptional clinical homecare services to more than 100,000 patients in their own homes, workplaces, or communities across the UK. Our comprehensive range of treatments spans from medication delivery to specialised nursing for complex conditions such as home parenteral nutrition, chemotherapy, IV antibiotics, enzyme replacement therapy, rheumatoid arthritis, multiple sclerosis, and beyond. Working in collaboration with the NHS, pharmaceutical companies, and private medical insurers, we prioritise patient care and are guided by our values of Delivering together, Being Accountable, Giving it our all and Continually Improving to provide the highest standards of service delivery and patient outcomes. We pride ourselves on being an equal opportunities employer, committed to diversity &amp; inclusion, taking a person-centred approach to our interview process that is fair and free from both discrimination and bias. If you have any reasonable adjustment needs arising from a disability or medical condition to fully participate in the recruitment process, please discuss this with our resourcing team</li> </ul></li></ul>

Risk & Compliance Manager

Calling all innovators - find your future at Fiserv. We're Fiserv, a global leader in Fintech and payments, and we move money and information in a way that moves the world. We connect financial institutions, corporations, merchants, and consumers to one another millions of times a day - quickly, reliably, and securely. Any time you swipe your credit card, pay through a mobile app, or withdraw money from the bank, we're involved. If you want to make an impact on a global scale, come make a difference at Fiserv. Job Title Head of UK Compliance &amp; MRLO What does a successful Head of UK Compliance and MLRO do at Fiserv? We are hiring a Head of UK Compliance and MLRO (SMF 16 and 17) to oversee compliance with regulatory compliance frameworks in the UK from the second line of defence. You will have proven experience in Compliance and Financial Crimes roles, ideally in payments and/or merchant acquiring, and will report to the SVP, Head of Compliance EMEA and Global Head of Data Privacy. What you will do: <ul><li>Lead the UK Compliance function to ensure the timely and effective provision of high-quality compliance services, advice, and guidance. Manage and develop direct reporting staff in the UK Compliance team. Manage the relationship with and act as the firm's representative to the PRA and FCA with regards to compliance.</li><li>Act as the UK MLRO and primary point of contact with the FCA and other relevant regulators, as required and in line with the licensing developments.</li><li>Oversee the submission of Suspicious Activity Reports (SARs) and other regulatory filings in compliance with jurisdictional requirements.</li><li>Advise on applicable laws, rules, regulations, and codes of practice to ensure business is conducted in a compliant manner. Manage the firm's compliance procedures, documentation, and monitoring systems, with responsibility for change management initiatives to enhance local and global compliance processes.</li><li>Provide strategic and tactical consulting to lines of business and branches on issues related to compliance. Inform, advise, and educate business units, senior management, and relevant Boards of Directors on all compliance responsibilities.</li><li>Develop, implement, and manage relevant Compliance monitoring programmes. Investigate and report upon actual and regulatory breach and propose remedial action.</li><li>Liaise with the global Compliance Officers and MLROs across licensed jurisdictions in EMEA APAC, LATAM and NA, fostering development and risk-based program implementation aligned with overall goals.</li><li>Identify all significant risks within your area and to assign ownership and responsibility for the management of these risks. Responsible for the ongoing management of these controls and ensuring that any control shortfalls are identified and immediately corrected and escalated where appropriate.</li></ul>What you will need to have: <ul><li>Proven experience at a senior level in risk &amp; compliance roles</li><li>Understanding of key regulatory requirements and expectations</li><li>Ability to deliver and embed Regulatory Management Frameworks</li><li>Strong working knowledge of payment service and Merchant acquiring</li><li>Extensive experience working with and presenting to regulators, auditors and bank partners</li></ul>What would be great to have: <ul><li>Compliance and/or financial crimes related qualification(s)</li></ul>Thank you for considering employment with Fiserv. Please: <ul><li>Apply using your legal name</li><li>Complete the step-by-step profile and attach your resume (either is acceptable, both are preferable).</li></ul>What you should know about us: Fiserv is a global leader in payments and financial technology with more than 40,000 associates proudly serving clients in more than 100 countries. As one of Fortune® magazine's "World's Most Admired Companies™" 9 of the last 10 years, one of Fast Company's Most Innovative Companies, and a top scorer on Bloomberg's Gender-Equality Index, we are committed to innovation and excellence. Our commitment to Diversity and Inclusion: We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. Warning about fake job posts: Please be aware of fraudulent job postings that are not affiliated with Fiserv. Fraudulent job postings may be used by cyber criminals to target your personally identifiable information and/or to steal money or financial information. Any communications from a Fiserv representative will come from a legitimate business email address. We will not hire through text message, social media, or email alone, and any interviews will be conducted in person or through a secure video call. We won't ask you for sensitive information nor will we ask you to pay anything during the hiring process. We also won't send you a check to cash on Fiserv's behalf. If you see suspicious activity or believe that you have been the victim of a job posting scam, you should report it to your local law enforcement.

Head of UK Compliance & MRLO

Compliance Manager Contract: Healthcare Location: London, EN2 8JL Hours of work: 40 Contract Type: Permanent This is a great opportunity to join NHS within its Healthcare section working on a key Compliance position. The Compliance Manager is a key role tasked with ensuring that all contractual, legislative, statutory, and operational obligations are met across the contract. This includes adhering to the requirements of PFI contracts, ISS business systems, and Trust policies and procedures. You will focus on maintaining high levels of performance, mitigating risks, and ensuring accurate, reliable, and timely information is available to support decision-making and continuous improvement. Job Description You will lead the charge in maintaining robust audit processes and driving continuous improvement across service delivery, helping to mitigate risks and enhance overall performance. By building strong relationships with stakeholders and fostering a culture of accountability, you will play a vital role in supporting operational excellence. This role is not only about meeting standards but also about identifying opportunities for system and process innovation to improve compliance and efficiency. This is a key appointment and the Post holder must possess a sound 'intelligent user' knowledge of practical IT systems, along with the technical skills and competencies to manage the information process. The Compliance Manager must have the inter-personal and communication skills necessary to ensure that service or contract breaches are identified, notified and any remedial actions required are undertaken in the appropriate notification line. In addition to the above the post-holder will co-ordinate and manage the Compliance (internal), Health &amp; Safety, and monitor/audit Training functions of the site in order to reduce risk to employees and the organisation. Key Responsibilities <ul> <li>Responsibility for the monitoring and reporting of Statutory and Legislative Compliance across the contract and for bringing this to the attention of managers and staff.</li> <li>Undertake research on technical matters pertaining to contractual or service compliance and liaise with internal experts as appropriate.</li> <li>Responsibility for monitoring of use of ISS internal business systems within the contract and ensuring compliance with the systems (as defined and measured by formal ISS central audits.</li> <li>Manage the process of carrying out site-instigated ISS audits, the Flag Audits and plan training/rectification actions by relevant Service Departments to improve audit scores. </li> <li>Assist Service Managers with the development of new systems, where appropriate, and site-specifying of standard ISS systems, where appropriate, with the involvement of ISS central Audit Department.</li> <li>Attend ISS, Project Co and/ or Trust Compliance Meetings and Reviews and liaise as required.</li> <li>Attend an agreed random amount of Trust audits in relation to the Service Level Specifications. </li> <li>Attend Trust/ Project Co Service Performance Reviews (as required)</li> <li>To record contractual variation Register/ Requests.</li> <li>Report on as part of the Monthly Client Report the Audit Plan for National Cleaning Standards for the Nursing Staff.</li> </ul>Professional and Personal Competencies/Qualifications <ul> <li>Focuses own and team's efforts on hard objectives and targets, prioritising as necessary.</li> <li>Prompts others in the team to formulate action plan to improve performance where necessary.</li> <li>Articulates long term ideas / solutions.</li> <li>Focuses on key issues and makes them clear for others.</li> <li>Reacts to client needs and develops appropriate solutions.</li> <li>Converts high level plans into detailed work programmes.</li> <li>Demonstrates persistence, energy and enthusiasm to overcome obstacles and achieve results for self and team.</li> <li>Distinguishes between activity and achievement when reviewing own and teams performance against set criteria and KPI's.</li> <li>Facilitates ideas for teams to consider.</li> </ul>The Company ISS is a world-leading workplace and facility management company, connecting people and places to make the world work better. Working with customers day by day, side by side, we understand every aspect of the user experience. Through a unique combination of intelligent solutions, high standards and people who care, to help our customers achieve their purpose, whether it's hospitals healing patients, businesses producing the next great innovation, or airports bringing passengers home to their families. ISS is committed to doing business the right way, taking its corporate responsibility very seriously. Our passion is people. We offer you a challenging and exciting career in an organisation with people at its heart. In ISS, everyone has the opportunity to develop, grow and make a difference. #ISSGreatPeople #ISSTalent #PeopleMakePlace ISS is proud to be a diverse and inclusive employer. ISS welcomes all applicants regardless of age, disability, gender identity or gender reassignment, marital or civil partnership status, pregnancy or maternity, race (which includes race, colour, nationality, ethnic or national origin and caste) religion or belief, sex, sexual orientation or educational background Our passion for inclusivity and diversity makes ISS a more creative, productive and happy place to work. If you have any further queries regarding this role, please contact the Resourcing Team by emailing <a href="mailto:resourcing.team@uk.issworld.com" target="_blank">resourcing.team@uk.issworld.com</a> Please click on the following link for more information on this role: Job Description If you are interested in learning about other opportunities at ISS, please join our Talent community by clicking on the following link: TalentPlace To find out more about what we do click here - <a href="https://www.uk.issworld.com/" target="_blank">https://www.uk.issworld.com/</a>

NLMH Compliance manager

Hard FM Technical Compliance Manager Semperian Infrastructure Group have an opportunity for a Hard FM Technical Compliance Manager to join the team on a full time, permanent contract basis. The role will report to the SPC General Manager and will be responsible for the front-line monitoring of the compliant delivery of Hard FM services by the Service Provider. The role involves managing inspections, audits, reporting, and monitoring remediation activities to guarantee compliance and efficiency across all technical operations, as set out in the contractual documents. Hard FM Technical Compliance ManagerResponsibilities <ul><li>Establish key relationships with Contract Representatives from client and Service Provider.</li><li>Attend meetings with Stakeholders to monitor and improve service delivery (Daily).</li><li>Monitoring of hard services including planned maintenance completion against the maintenance schedule and completion of reactive and remedial maintenance within the Contractual SLAs. </li><li>Ensure that all technical aspects of service outputs are delivered by the Service Provider, to comply with the Hard FM Services Contract and PFI Project Agreement on behalf of the SPC. </li><li>Ensure that works are delivered in a timely manner to avoid financial penalties. </li><li>Build relationships with service partners and attend regular planned meetings where appropriate and ensure full cooperation as and when required.</li></ul>Hard FM Technical Compliance ManagerRequirements <ul><li>Qualified at Degree level in either Mechanical or Electrical Engineering/Building Services </li><li>Knowledge and understanding of Electrical, Mechanical and HVAC systems &amp; compliance </li><li>Experience in the PFI Sector working in a large acute hospital</li><li>Demonstrated previous experience of management of Hard FM / Technical Services Contracts Version 01 3 of 3 Personal Attributes: Special Conditions:</li><li>The ability to influence change where required, along with customer facing attitude</li><li>Good communication skills with the mental agility to 'think on feet' and provide convincing practical solutions in a timely manner</li><li>Successful DBS check of relevant level </li></ul>About Semperian Group Limited Semperian Group is a dedicated team of infrastructure experts sharing a core understanding: that effective day to day management delivers value, stability and returns over the long term. As one of the largest SPV and Asset Management service providers to the PPP / PFI infrastructure market, we seek to protect and enhance the value of our investor's assets, which currently stand at £3bn. Location: Bromley Job Type: Permanent, full time Salary: Up to £85,000 Diversity: We're incredibly proud to be an equal opportunity employer and are working to create a more diverse and inclusive workplace that celebrates diversity and creates equity amongst our employees. We are proud of the work we have done so far, but know that we still have a way to go both as an employer and in supporting the industry to represent the communities and society we operate in. We encourage applications from candidates of all backgrounds. If you require reasonable adjustments at any part of your application, please get in touch. Semperian Group welcome applications from ex-service and other former military personnel. We are committed to honouring the Armed Forces Covenant and supporting the Armed Forces community.

Hard FM Technical Compliance Manager

Job Description: Leonardo UK Ltd is seeking Customs Compliance Specialists to work within its Trade Compliance Function to support the management of all aspects of UK Customs Compliance and, as required, the import regulations of other countries, such as the US, as they relate to Leonardo's business operations in the UK. You will be part of a team, which provides a business support service, including advice and guidance, to Leonardo's Electronics and Cyber business operations and functions to ensure the business remains compliant with UK and other relevant trade control laws and regulations. This is a hybrid role and will involve some national travel and possibly international travel. Key Accountabilities/Areas of Responsibility In your role as a Customs Compliance Specialist, you will provide support to enable prompt customs clearance and delivery of goods to the customer. Key responsibilities: <ul><li>Provide advice and guidance to individuals and Project Teams at all levels within the Electronics and Cyber business to ensure compliance with UK and foreign import / export laws, as well as conforming to internal corporate policies and procedures.</li><li>Ensure record keeping is in accordance with regulatory requirements and company procedures to comply with HMRC and DBT regulations.</li><li>Support the management of all Customs special procedures held by LDO such as Inward Processing, Outward Processing, Temporary Admission, Custom Warehouse, and Authorised Economic Operator. Ensuring they are updated, maintained and renewed, as and when required.</li><li>Ensure robust processes and monitoring of agent clearances are implemented to guarantee HMRC declarations are made correctly and in real-time.</li><li>Ensuring all reporting requirements such as bills of discharge are completed correctly and submitted on time.</li><li>Complete compliance checks on UKIMS/UKEMS/SAP/SAP GTS to ensure accuracy and integrity of data. Identify any inaccuracies and address as required. </li><li>Analyse and interrogate MSS data as part of a risk assessment and review of Customs regimes usage.</li><li>Ensuring robust processes are in place to review transaction completed by the incumbent third party Import/Export teams to ensure declarations and clearance are in accordance with LDO instructions.</li><li>Processing of re-exports of imported goods under Customs control to ensure financial liabilities are discharged correctly.</li><li>Good knowledge of Postponed VAT Accounting (PVA) regime. Working with the relevant stakeholders internally and externally to ensure the use of PVA have been done correctly.</li><li>Support preparations for internal/external audits relating to UK Customs matters.</li><li>Provide advice and guidance to Project Teams to ensure compliance with internal corporate policies and procedures. This will include advising the internal business of the most appropriate and valid way to manage imports of LDO owned material, Customer material and repairs.</li><li>Ensure import clearance instructions to freight agents in an efficient and timely manner to enable prompt customs clearance and delivery of goods to the business.</li><li>Monitoring of C88s to ensure freight agents have imported goods correctly, and request amendments where required.</li><li>Process internal reports and ensure record keeping requirements are completed compliantly and in line with HMRC regulations.</li><li>Support meetings with the incumbent Logistics/Freight Provider to ensure KPIs are being met and performance is as expected and in line with the Service Level Agreement.</li><li>Support training needs for incumbent Logistics/Freight provider to ensure processes and work instructions are followed.</li></ul>Skills, Qualifications &amp; Knowledge Required. Essential <ul><li>Experienced UK Customs practitioner with detailed knowledge of UK import and exports requirements</li><li>Good knowledge of Customs Special Procedures including AEO</li><li>Experience of Customs Valuation, Tariff Classification and Origin of goods</li><li>Excellent written skills</li><li>Strong interpersonal/influencing skills to support decision-making based on credible knowledge of International Trade.</li><li>Presentation skills in order to deliver training</li><li>Good all round computer literacy including Microsoft Office applications</li><li>Meeting management skills</li><li>Strong interpersonal skills</li></ul>Desirable <ul><li>Awareness of, and general familiarity with, SAP ERP (ECC6 or S4/HANA, SAPGTS)</li><li>Good understanding of trade compliance considerations for international support programmes within the aerospace, defence and security sector.</li></ul>Security Clearance You must be eligible for full security clearance. For more information and guidance please visit : <a href="https://www.gov.uk/government/publications/united-kingdom-security-vetting-clearance-levels" target="_blank">https://www.gov.uk/government/publications/united-kingdom-security-vett…</a> Life at Leonardo With a company funded benefits package, a commitment to learning and development, and a flexible approach to working hours focused on the needs of both our employees and customers, a career with Leonardo has never offered as many opportunities or been more accessible to as many people. <ul><li>Flexible Working: Flexible hours with hybrid working options. For part time opportunities, please talk to us</li><li>Company funded flexible benefits: Access to private healthcare, dental schemes, Workplace ISA, Go Green Car Scheme, technology and lifestyle options (£500 annual allowance)</li><li>Holidays: 25 days plus bank holidays, option to buy/sell leave and to accrue up to 12 additional flexi leave days per year</li><li>Pension: Award winning pension scheme (up to 10% employer contribution - please note that from April 2024 this amount will increase to up to 15% employer contribution.)</li><li>Wellbeing: Employee Assistance Programme with access to free mental health support, financial wellbeing support and network groups to demonstrate our ongoing commitment to diversity &amp; inclusion (Enable, Pride, Equalise, Reservists, Carers)</li><li>Lifestyle: Discounted Gym membership, Cycle to work scheme </li><li>Training: Free access to more than 4000 online courses via Coursera </li><li>Referral Incentive: You can earn a reward for successfully referring a friend or family member </li><li>Bonus: Scheme in place for all employees at management level and below</li></ul>For a full list of our Company benefits please visit our website. Leonardo is a global high-tech company and one of the key players in Aerospace, Defence and Security. Headquartered in Italy, Leonardo has over 45,000 employees, of which 8,000 are based at 8 sites throughout the UK. At Leonardo UK, we believe that a diverse and inclusive work environment unlocks our people's full potential and drives innovation and creativity. We work hard to offer a welcoming, accessible and inclusive place to work for all of our people, creating a culture where everyone can thrive, feel safe and have a sense of belonging and connection. This is a great opportunity to bring your talents and form an integral part of Leonardo's future. We can help you develop your skills and offer great opportunities to develop and grow, so why not join us. Primary Location: GB - Basildon Additional Locations: GB - Bristol Building, GB - Edinburgh, GB - Luton - Cap. Green 300, GB - Southampton Contract Type: Hybrid Working: Hybrid

Customs Compliance Specialist

Diasorin is a global leader in diagnostic solutions, pushing the boundaries of science and technology to create cutting-edge tools that improve healthcare worldwide. With a legacy spanning over 50 years, we've earned our reputation for excellence by developing innovative diagnostic assays and instruments that are trusted by healthcare providers around the world. Our broad offering of diagnostic tests and Licensed Technology solutions, made available thanks to ongoing investments in research, positions us as the player with the widest range of specialty solutions in the sector and identifies us as the "Diagnostics Specialist." Why Join Diasorin? <ul> <li>Impactful Work: When you join Diasorin, you become part of a team that's dedicated to improving lives. Your contributions will directly impact patient care, making a meaningful difference in the world.</li></ul><ul> <li>Global Reach &amp; Innovation: Our work transcends borders. Joining Diasorin means collaborating with colleagues from all over the world, expanding your horizons, and contributing to global healthcare solutions at the forefront of the diagnostic industry.</li></ul>Diverse and Inclusive Culture: We believe in the strength of diversity, and our inclusive culture reflects this commitment. We value your unique perspective and offer a supportive, collaborative environment where everyone can thrive. Join Our Team: If you're passionate about innovation, diversity, and making a positive impact on healthcare, Diasorin is the place for you. We're looking for passionate and talented individuals who are ready to embrace new challenges and drive healthcare solutions forward. Are you ready to be part of a dynamic team that's shaping the future of diagnostics? Join Diasorin and become a catalyst for change in the world of healthcare. Apply today and be a part of our exciting journey toward a healthier, more connected world. Together, we can make an impact! Summary In this role you will oversee and coordinate the Site Validation Programme. This will involve: leading and coordinating the Site Validation Review Board, overseeing the implementation of the S-VMP and managing and supporting Validation activities for new and existing Site validations. Responsibilities: <ol> <li>Oversee and coordinate the site Validation Programme.</li> <li>Lead and coordinate the site Validation Review Board, overseeing the implementation of the S-VMP.</li> <li>Manage and support Validation activities for new and existing site validations including:</li></ol> <ul> <li>Process Validation: Develop, execute, and maintain validation protocols and reports for all manufacturing processes in accordance with ISO 13485 and IVDR regulations.</li></ul><ul> <li>Cleaning Validation: Establish and perform cleaning validation protocols and studies to ensure compliance with company and regulatory requirements, ensuring the cleanliness of manufacturing equipment and environments.</li></ul><ul> <li>Test Method Validation: Validate and verify analytical and testing methods to ensure they are suitable for their intended use, producing reliable and reproducible results.</li></ul><ul> <li>Spreadsheet Validation: Conduct validation of spreadsheets used for data handling and analysis to ensure accuracy and compliance with regulatory standards.</li></ul><ul> <li>Contribute to project Cross Functional Teams (CFTs) as a Validation subject matter expert, ensuring adherence to validation policies, procedures, safety, and training.</li></ul><ul> <li>As required, liaise with engineering and external vendors regarding equipment User Requirements Specifications (URS's), Factory Acceptance Trials (FAT's) and any other associated validation issues.</li></ul><ul> <li>Develop, execute, and maintain validation protocols, assigning tasks to site personnel as necessary. Drawing on expertise in validation methodologies and practices, as well as integrating risk management principles like ISO 14971, is crucial for protocol success.</li></ul><ul> <li>Review and approve validation documentation to ensure compliance with ISO 13485 and relevant regulatory standards.</li></ul><ol> <li>Responsible for managing site risk management plans and reports, ensuring compliance with regulatory standards and company policies.</li> <li>Actively participate in site projects, including technology transfers and new product development initiatives, ensuring that validation and compliance considerations are integrated from the onset.</li> <li>Prepare for and support internal and external audits, including regulatory inspections.</li> <li>Develop and roll out Validation training for the department and site.</li> <li>Liaise with and seek appropriate advice from the other DiaSorin plants worldwide.</li> <li>Approach the role in a flexible manner and be prepared to adapt to requirements outside of the immediate role that are essential to the organisation.</li></ol> Experience, Qualifications and Skill Requirements: <ol> <li>This role is crucial for ensuring that products and processes comply with internal standards as well as external regulatory requirements, including ISO 13485. The ideal candidate should have a strong background in validation processes, quality systems, risk management and regulatory compliance within the medical device or IVD sector. IVDD/IVDR compliance knowledge advantageous.</li> <li>Proficient in validation methodology, including process, cleaning, test method, and spreadsheet validation.</li> <li>Familiarity with risk management principles and practices in a regulated environment.</li> <li>Excellent analytical, problem-solving, and organizational skills.</li> <li>Science based degree beneficial.</li> <li>Managing timelines and prioritising workload to meet business needs.</li> <li>Good interpersonal and communication skills.</li> <li>Excellent attention to detail.</li> <li>Highly motivated, proactive and solution focused.</li> <li>The ability to adapt to changing priorities.</li></ol> Diasorin is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status, and will not be discriminated against on the basis of disability. In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and Canada and to complete the required employment eligibility verification document form upon hire. Diasorin is committed to providing reasonable accommodations for qualified individuals with disabilities. If you are a US or Canada candidate and require assistance or accommodation during the application process, please contact the North America Talent Acquisition Team at <a href="mailto:hrtalent@diasorin.com" target="_blank">hrtalent@diasorin.com</a> or 1-800-328-1482 to request an accommodation. The above job description is intended to describe the general content, identify the essential functions, and set forth the requirements for the performance of this job. It is not to be construed as an exhaustive statement of duties, responsibilities, or requirements. Diasorin reserves the right to modify or amend this job posting as needed to comply with local laws and regulations. Please note that offers of employment at Diasorin may be contingent upon successful completion of a pre-employment background check and drug screen, subject to applicable laws and regulations. This position is not eligible for partnership with a third-party search firm vendor without expressed, written consent from the Diasorin Human Resources Department.

6 Jobs in Basildon, UK