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We want you to feel inspired every day. We're future-focused and our business is growing. We succeed together through passion, commitment and teamwork, and so can you. We are currently recruiting for a Process Compliance Officer to join the Manufacturing team on a 12 month fixed-term contract. The purpose of this role is to work alongside the GMP Manufacturing teams to ensure the timely completion of batch related issues, as well as ensuring compliance with internal and external GMP requirements. Our manufacturing team is a critical part of Oxford Biomedica's operations. We produce multiple clinical and commercial lentiviral vector based gene therapy products Your responsibilities in this role would be: <ul> <li>Lead investigations and root cause analysis into process and facility deviations </li> <li>Identify and implement effective Corrective and Preventative Actions (CAPAs) </li> <li>Conduct regular self-inspections of the Manufacturing department. </li> <li>Organise and facilitate individual and group training with regard to manufacturing SOPs and procedures.</li> <li>Lead updates to batch and facility documentation to capture new learnings and best practices. </li> <li>Lead and promote process improvement ideas to increase the department's efficiency.</li> <li>Key link between the QA department and the Manufacturing department.</li></ul>We are looking for: <ul> <li>Experience of working within a GMP pharmaceutical/biotechnology environment.</li> <li>Experience of leading and being a part of structured problem solving events.</li> <li>Experience with Manufacturing documentation such as SOPs, Deviations, Change Controls Risk Assessments and CAPAs </li> <li>Competency in Microsoft Office </li> <li>Familiarity with Root Cause Analysis techniques and the ability to amalgamate and interpret complex data in an investigative capacity would be an advantage</li> <li>Demonstrable process orientated approach to investigations.</li> <li>Organised, self-motivated, pragmatic, and have an excellent attention to detail. </li> <li>Have experience of continuous improvement</li></ul>About Us: OXB is a quality and innovation-led viral vector CDMO with a mission to enable its clients to deliver life changing therapies to patients around the world. One of the original pioneers in cell and gene therapy, we have more than 25 years of experience in viral vectors; the driving force behind the majority of gene therapies. OXB collaborates with some of the world's most innovative pharmaceutical and biotechnology companies, providing viral vector development and manufacturing expertise in lentivirus, adeno-associated virus (AAV) and adenoviral vectors. OXB's world-class capabilities span from early-stage development to commercialisation. These capabilities are supported by robust quality-assurance systems, analytical methods, and depth of regulatory expertise. What's in it for you: <ul> <li>Highly competitive total reward packages</li> <li>Wellbeing programmes</li> <li>Development opportunities</li> <li>Welcoming, friendly, supportive colleagues</li> <li>A diverse and inclusive working environment</li> <li>Our values are: Responsible, Responsive, Resilient, Respect</li> <li>State of the art laboratory and manufacturing facilities</li></ul>We want you to feel inspired every day. We're future-focused and our business is growing rapidly. We succeed together through passion, commitment and teamwork, and so can you. Collaborate. Contribute. Change lives

Process Compliance Officer - 12 month FTC

Vacancy Name Information Security Compliance Manager Vacancy No VN3475 Employment Type Full Time Work Place Location City Andover Location Country United Kingdom Secondary Country Role Pitch CloudPay is looking for a highly motivated Information Security Compliance Manager to support the rapid expansion of the company. The Information Security Compliance Manager will ensure that our payroll and payment products and services comply with industry regulations, security standards, and internal policies. Working closely with technology, legal, and operational teams, the successful candidate will drive security initiatives, conduct risk assessments, and manage internal and external audits to uphold a strong security and compliance posture. Key Responsibilities Daily Duties and Main Responsibilities will include: • Policy and Process Development Develop and enforce policies that comply with regulations and standards such as GDPR, ISO27001, SOC2, and NIST. Continuously monitor evolving regulations and standards to assess relevant impacts to the security framework at CloudPay Work closely with stakeholders to advise on the appropriate implementation of security policies to protect customer data. Ensure that policies are communicated to all employees. • Audit and Security Assessments Prepare for and support external audits related to information security such as ISO27001, ISO22301 and SOC. Support the vendor assurance team with the interpretation and review of security elements of compliance assessment responses Work closely with stakeholders on information security questionnaires from prospects and existing customers. • Security Risk Assessment Management Conduct security risk assessments on new products or enhancements to existing products, working with stakeholders to advise on risks and potential mitigation strategies. Work with product and development teams to ensure security controls are embedded into new products and enhancements. Act as subject matter expert to advise stakeholders on the security impacts of new products, services and partnerships. • Incident Response and Reporting Work closely with the technology teams on security incidents to ensure compliance with Incident Response Plans. Support relevant teams with communications and root cause analysis. Monitor and ensure that actions arising from security incidents are logged and managed through to completion. • Continuous Improvement and Monitoring Monitor the effectiveness of security controls through periodic assessments and identify areas for improvement. Ensure that nonconformities are appropriately captured and managed through to completion. Description Attributes and Experience Required: • Proficiency in creating and maintaining information security policies and procedures to a high-quality standard • Strong, practical knowledge and experience with ISO27001 and SOC frameworks, including implementation and compliance analysis • Comprehensive knowledge of common information security technologies, tools, and best practices (i.e. Microsoft Azure, Vulnerability Management, Incident Management, Risk Analysis, Security Awareness and Training etc.) • Experience in conducting risk assessment and implementation of security controls • Exceptional attention to detail • Ability to use initiative to solve problems • Ability to work autonomously when required Preferred • CISSP, CISM, CRISC, CISA, PCI-DSS certification, or other relevant certifications preferred. • Experience working in a global technology company • Experience of working in financial services #LI-AC1 #LI-HYBRID Benefits Package and Benefits: • Competitive annual salary • 25 days annual leave, plus bank holidays • Flexible remote working • Birthday leave • Flexible pension contribution • Life assurance x4 • Private medical insurance • Earned Wage Access (via CloudPay Now app) • Personal and professional development opportunities • Friendly working environment CloudPay is committed to being an equal opportunities employer.

Information Security Compliance Manager

Overview Do you want to be help enrich the lives of learners worldwide? At RM, we've been pioneers of education technology since 1973. We provide technology and resources to the education sector supporting over 10 million students around the world. We work with 28,000 schools, nurseries, and education trusts in 115 countries to deliver customer-centric solutions that improve education outcomes worldwide. What we do helps learners at all stages of their lives, from preschool to higher education and professional qualification, we partner with schools, examination boards, central governments and other professional institutions, to enrich the lives of learners. RM is a leading supplier of technology and resources to the education sector, supporting schools, teachers, and pupils across the globe - from pre-school to higher education - including examination boards, central governments, and other professional institutions. RM Group operates through three businesses: Technology (Managed Services, Software and Infrastructure for Schools), Assessment (Software and Services) and TTS (Education Resources). RM Technology is a market-leading supplier of ICT products and services to UK schools and colleges to deliver a technology environment that improves learning outcomes and makes the most of IT investment, driving focus through four lines of business: Managed Services, Software, Hardware and Broadband Visit us here to find out more: <a href="http://www.rm.com/education" target="_blank">www.rm.com/education</a> The Role The Compliance Manager is based within the Delivery Operations Standards Office (DOSO) and reports to the Service Delivery &amp; Standards Manager. The DOSO defines and documents all operational practices and processes, ensures the adoption of same, and enforces proper compliance with, and utilization of, standard operations. As Compliance Manager, you will take a "hands on" approach to compliance, supporting our Service Delivery &amp; Standards Manager in defining, developing, supporting, and governing service quality and compliance across the Technology business. You will manage and maintain our established ISO certifications including ISO 9001, ISO 22301, and ISO 27001 ensuring that administration and activities required for compliance are complete, driving and supporting continuous improvement across these, acting as a specialist and leading related activities in these areas. You will support the ISO 270001 lead implementer in the transition to ISO27001:2022 from the 2013 versions currently held by the Technology business. You will support functional managers in adherence to process including key activities such as Incident and Problem Management and Change Enablement ensuring that the business learns from feedback and that opportunities for improvement are captured and implemented as part of a culture of continual service improvement. You will build and maintain strong relationships with key stakeholders across the Technology business, acting as a specialist advisor for them on standards and service quality, and develop support initiatives to ensure service excellence. Responsibilities Main Responsibilities include but are not limited to: Service Quality <ul><li>Collaborate with the Service Delivery &amp; Standards Manager in defining and developing operational standards, processes, and practices within Technology to ensure consistent and efficient ways of working. </li></ul><ul><li>Ensure the delivery of high-quality services across our customer base through monitoring and evaluating service performance against defined service quality standards. </li></ul><ul><li>Work with the wider Technology group to ensure we meet the requirements of our key ISO standards, internally leading, participating in, and supporting, both internal and external audits as appropriate, and coordinating delivery of any improvement programmes that follow. </li></ul><ul><li>Support the ISO 27001 Lead Implementer in the transition to the 2022 standard. </li></ul><ul><li>Fulfil the role of process owner for agreed process and practices </li></ul>Continual Improvement <ul><li>You will be responsible for identifying process inefficiencies and collaborating with stakeholders from across the business to develop and implement process improvements, often using your skills and experience to lead and implement such improvements. </li></ul><ul><li>Monitor and act on customer feedback from across the customer base, ensuring it is used to inform improvement recommendations, decisions, and activities. </li></ul><ul><li>This will include streamlining existing activities and identifying opportunities to eliminate waste and inefficiencies e.g., through automation of repetitive tasks.</li></ul>Experience Skills and Experience You will have proven experience of: <ul><li>Working in an ITIL and ISO aligned environment where you will have played an active role in all aspects of process and practice development, implementation, and management to ensure quality of delivery. </li></ul><ul><li>Representing the business in an external audit context e.g., participation in ISO audits covering areas such as Quality, Information Security and Business Continuity management. </li></ul><ul><li>Leading and coordinating improvement projects, involving people from different functional specialisms. </li></ul><ul><li>Applying Lean principles and practices within a service context and successfully embedding resultant improvements. </li></ul><ul><li>Confidently and decisively managing and coordinating complex scenarios involving multiple stakeholders across varying levels of seniority. </li></ul>You will be: <ul><li>Multitasker, able to manage multiple workstreams to ensure compliance with established standards and policies. </li></ul><ul><li>A strong collaborative team player, able to work well with others ensure all functions work in concert to deliver business strategy and outcomes. </li></ul><ul><li>A practical problem solver, with the ability to manage and resolve complex issues arising from people, process and technology. </li></ul><ul><li>A confident communicator and influencer, motivated by managing a wide range of business relationships which may include internal stakeholders, customers, and suppliers. </li></ul><ul><li>Motivated and passionate about all aspects of organisational improvement. </li></ul>You will have: <ul><li>A practical, evidence based, understanding of relevant ISO standards e.g. ISO 9001, ISO 22301 and ISO27001 and the internal audit process which may be evidenced through certification (advantageous). </li></ul><ul><li>Significant experience of leading and delivering process improvement in a service context (essential) which may be evidenced through relevant certification. </li></ul><ul><li>Practical knowledge of ITIL V4 (essential) which may be evidenced through certification. </li></ul><ul><li>Broad experience and understanding of managing functions within an IT service operation that will inform and support your approach to quality and improvement. </li></ul><ul><li>A practical knowledge / experience of data protection (GDPR) and associated activities (advantageous) </li></ul><ul><li>A strong alignment to our Five to Drive values and behaviours. </li></ul>What's in it for you? What's in it for you? At RM we have "My Work Blend @RM" which provides office-based colleagues with multi location and hybrid working options to suit them. As well as your office base, you can spend a proportion of your time working at other locations that suit your role and your life, including home, other offices, customer sites, distribution centres or on the move. We encourage you to discuss arrangements for this role with your potential line manager during the recruitment process. We expect how we make best use of hybrid working may continue to adapt as we adjust to our new ways of working. As well as a competitive salary and our core benefits package which includes private medical healthcare, life assurance and a Group Personal Pension Plan with higher contribution levels available, some roles are also eligible for a performance-related bonus. There are lots of voluntary benefits too. You could buy additional annual leave, join our dental plan, sign for a health assessment, or take part in our cycle to work scheme. You could even earn yourself an extra bonus for successfully recommending a friend or family member for a position within RM. To better reflect the society that we serve, we're committed to building a diverse workforce and creating an inclusive and welcoming environment for all. To achieve this, we create teams of talented people from different backgrounds and experiences and strive to be a business where our people can bring their whole selves to work. We also want to make the recruitment process as inclusive as possible for everyone. Should you require additional support with your application or through the interview process, please contact us at <a href="mailto:recruitment@rm.com" target="_blank">recruitment@rm.com</a>. Unfortunately, we are unable to offer sponsorship for this role.

Compliance Manager

HealthHero is a digital-first, end-to-end healthcare provider. We connect smart digital tools with gold-standard clinical expertise to enhance people's whole health and optimise healthcare efficiency. Active in the UK, Ireland, France and Germany, our mission is simplifying healthcare, improving lives. Being the European market leader, HealthHero is leading the way on shaping the virtual healthcare industry. We are seeking a Quality and Compliance Manager to work in our Clinical Product Team. In this role you will: <ul> <li>Provide support and guidance to the organisation on all aspects of Product Quality, Compliance &amp; Governance, </li> <li>Act as a Business Partner for therelevant Department/Business Area, with specific focus on Medical Device regulations</li> <li>Manage the quality and compliance of the whole product lifecycle, including compliance and maintenance of relevant standards and certifications.</li> </ul>You will be a reference point to the organisation and a champion of our Quality and improvement culture, for all areas of Clinical Product governance and the subject matter expert in their specialist area. You will be required to exercise discretion, initiative, pragmatism, independent judgement and decision making and have the ability to deliver a high-quality service at all times. The role is suitable for hybrid working from home and at our Bracknell office and may involve some travel to other HealthHero sites or external partners as required. Requirements Management and coordination of the Clinical Product Quality and Compliance function, ensuring effective engagement with our product, technical and client services teams and external stakeholders where appropriate. Supporting and enabling our Clinical Product family and market expansion plans, using judgement and experience when liaising with key stakeholders, to escalate complex queries or issues to colleagues, the Compliance Director or Clinical Safety Officer as required. Key Responsibilities: <ul> <li>Chair relevant meetings and committees as required as part of the Quality Management System </li> <li>Ensuring effective systems and processes for proactive development of the HealthHero Clinical Product family and the integration of HealthHero functions and entities </li> <li>Lead the process of transitioning our Class 1 Medical Devices to Class 2a under the EU MDR framework, acting as the point of contact with the Notified Body</li> <li>Leading preparations for ISO13485 audits and working with the Governance Team to ensure that our certified quality management system is maintained throughout the year</li> <li>Ensure compliance with clinical risk management standards through manufacturing, implementation and documentation</li> <li>Lead support and liaison with teams and stakeholders, acting as a point of escalation for governance of Clinical Product development, specifications and customer requirements </li> <li>Providing information for reported Quality and Safety Issues, enabling the Compliance Director and Clinical Safety Officer to be informed in the in the appropriate escalation and reporting to relevant stakeholders including MHRA</li> <li>Ensuring effective systems to evidence Clinical Product performance to specification and clarify the responsibilities of each partner and stakeholder within product development</li> <li>Auditing of key systems, ensuring appropriate and effective documentation of processes including training and support materials</li> <li>Compiling and maintaining QA documentation to support business development, including reviewing bid responses, providing information for applications for procurement frameworks and for diligence activities </li> <li>Manage the creation and maintenance of Clinical Product Safety Documentation and Technical Files, within the required timescales and in compliance to relevant regulatory standards</li> <li>Ensure the development and implementation of processes to monitor and report any actions resulting from recommendations of internal and external audit reviews.</li> <li>Provide support and advice to staff across the organisation in the implementation and review of localised requirements for compliance, governance and regulations within the global market</li> <li>Provide periodic reporting to the Governance Team and other Stakeholders.</li> <li>Depending on the business need, have line management responsibilities.</li> </ul>Accountability: You will report directly to the Compliance Director Requirements: <ul> <li>Knowledge and experience of quality management and the governance of medical devices within an ISO 13485 accredited healthcare organisation</li> <li>Able to gather and assimilate information quickly and effectively</li> <li>Ability to write and contribute to complex documents and reports</li> <li>Understanding of audit and its application in practice</li> <li>Working knowledge of healthcare regulation, standards and guidelines</li> <li>Educated to degree level or equivalent </li> <li>Desirable - have experience of software as a medical device including MDR submissions </li> </ul>Personal qualities &amp; behaviours required: <ul> <li>Tenacity</li> <li>Credibility </li> <li>Resilience </li> <li>Articulate </li> <li>Appropriate DBS clearance</li> </ul>Benefits <ul> <li>Company Pension scheme</li> <li>Access to HealthHero healthcare services, including Private 24/7 GP service and Employee Assistance Programme</li> <li>25 days holiday +8 days bank holiday and an extra day off for your birthday</li> <li>Electric Car scheme</li> <li>Cycle to work scheme</li> <li>Salary Exchange scheme</li> </ul>

Quality and Compliance Manager

As Enterprise Manager for EMEA within Global Trade Compliance you will be responsible for the execution and maintenance of CSL's world-class import-export compliance program in the EMEA Region. Its focus is to ensure all CSL legal entities operating in EMEA are compliant with all applicable customs and trade regulations whilst maximizing feasible savings for the business. You will report into the CSL Enterprise Senior Manager, EMEA Trade Compliance You will be responsible for the day-to-day oversight of EMEA import and export transactions, ensuring compliance with local Customs and trade laws &amp; regulations including export control laws, free trade agreements, pharmaceutical products specific partner government agencies requirements: import, export permits or registrations, duties mitigation programs, HS classification, origin, preference, and customs value determination. This position is responsible to monitor compliance readiness of CSL sites in the EMEA region. You will support EMEA CSL Customs and Trade operations in the region and manage customs brokers, and or other outsourcing providers in partnership with the logistics teams. Also partnering directly with the various CSL strategic departments, business units, and functional area leaders to implement process improvements, operational excellence, and optimize duty spend with all applicable duty mitigation programs. You will work closely with the Global Trade Compliance Program function to implement CSL Global Trade Compliance Policies, deploy regional and local procedures, monitor changes in trade regulations and inform GTC management about changes and impact to CSL, monitor the compliance readiness of the region through the management of the CSL import and export compliance risk-assessment, on site compliance reviews (audits), and support all external government audits. You will interface with CSL Business Management, CSL Global Supply chain and Logistics, Regional compliance Leadership team, customs brokers, freight forwarders, internal/external legal counsel, customers, suppliers, and CMOs. Position will also provide support to develop training materials and support the CSL Global Supply Chain with all departmental goals and objectives. Responsibilities include: - <ul><li>Implementing CSL Global Trade Compliance Policies, guidelines, develop and deploy regional and local procedures, monitor the compliance readiness of the region through the management of the CSL import and export compliance risk-assessment, on site compliance reviews (audits), and support all external audits.</li><li>Monitoring regional key industry developments, legislative, and regulatory changes affecting CSL businesses, assess impact, and translate into processes and controls.</li><li>Driving efficiency throughout the import and export processes, develop import export data, duty spend and savings metric monthly reports!</li><li>Overseeing customs brokers in the region: KPIs, develop broker SOPs, adherence to contract obligations, performance, reporting of export and import data as per CSL requirements, monitoring POAs.</li><li>Lead transition and implementation to new selected brokers.</li><li>Leading on regional and local cross-functional teams responsible for EMEA region and customs operations.</li><li>Implementing the EMEA region record keeping, ensures completeness as per regional, local requirements and CSL internal Policy.</li><li>Overseeing HS and ECCN classification as well as database and GTS Master data.</li><li>Responsible for origin and preference determination, including LTSD process, customs value, duties and VAT for imports and duty program utilization as per CSL Policies. Support complex customs valuations requirements for non-commercial shipments and license/permit determination/application. Responsible for best customs regimes determination</li><li>Identifying risks and opportunities in the EMEA region and report to the Global TC team</li><li>Supporting Government audits and Customs Certifications, Internal Corporate and GTC audits. Perform post entry audits of CSL entities entries.</li><li>Identifying duty VAT for cross border tax mitigation programs, analyse cost benefits and lead implementation of duty savings.</li><li>Managing e GTS and Master data: denied parties Screening, Trade embargoes Blocks, and other IT GTS related upgrades and projects. </li></ul>Qualifications, skills, and Experience: - <ul><li>Experience in highly regulated, multi-location environments, cross functional experience is preferred.</li><li>Experience in managing complex Customs and trade operations.</li><li>Expertise in SAP GTS System and related IT projects</li><li>Experience with Customs and Export controls regulations, HS and Explanatory Notes, binding rulings, and Customs Valuation rules, as well as a thorough knowledge of entry processing, international freight industry standards and practices, and INCOTERMS.</li><li>Skilled with special Customs programs (inc. FTAs, Value Reconciliation, IPR, OPR, Tariff Suspensions, bonded Warehouse etc.)</li><li>Excellent skills in organization, prioritization, and negotiation; must excel under pressure.</li><li>Able to collaborate cross-functionally to drive peak performance.</li><li>Must be self-motivated, goal oriented, and able to work independently in producing results.</li><li>Proficient with: Microsoft Word, Excel, PowerPoint with ability to develop skills with other programs as required.</li><li>Understands Quality systems and importance of systems, operational excellence culture and behavior to organizations.</li><li>Experience in the pharmaceutical industry or other similarly regulated industry.</li><li>Ability to analyze and utilize data to drive decisions and priorities.</li><li>Able to influence and challenge senior leaders and peer groups.</li><li>Comfort around senior management.</li><li>Experience in understanding industry trends and changes to practice standards so CSL remains an industry leader.</li><li>Displays strong level of engagement at all levels of the organization.</li><li>Excellent written and verbal communications skills in English.</li></ul>Our Benefits CSL Seqirus is committed to attracting and retaining world-class employees who are valued for their contributions to achieving business objectives. Learn more about some of the benefits you can participate in when you join CSL Seqirus. About CSL Seqirus CSL Seqirus is part of CSL Limited (ASX: CSL). As one of the largest influenza vaccine providers in the world, CSL Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. Learn more about CSL Seqirus. We want Seqirus to reflect the world around us As a global organisation with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity &amp; Inclusion at CSL Seqirus. Do work that matters at CSL Seqirus! Watch our 'On the Front Line' video to learn more about CSL Seqirus

EMEA Enterprise Trade Compliance Manager

Job Description We are looking for a compliance officer to join our firm who will be responsible for ensuring we are compliant in all aspects of regulatory and legal requirements. The successful candidate will assist management and staff to identify and manage regulatory risks. Main Functions and Responsibilities <ul> <li> Provide support and on-going assistance to the COLP; COFA; MLRO and DPO in their daily compliance activities. </li> <li> Ensure we are compliant at all times with government and SRA regulations. Investigate any irregularities. </li> <li> Monitor compliance - ensure that CI complies with legal and ethical guidelines. </li> <li> Identify potential risks - identify activities and practices that risk violating regulations and SRA standards. </li> <li> Manage conflict queries and higher risk conflict queries with the relevant Officer. </li> <li> Perform routing risk assessments to understand compliance risk, scope and significance. </li> <li> Administration tasks as required to ensure all policies, plans and procedures are kept up to date. </li> <li> Assist the Operations Team with tasks as required. </li> </ul>Requirements and Skills <ul> <li> Regulatory Knowledge, which laws and regulation apply to CI. </li> <li> Data Analysis, analytical skills to research and interpret data. </li> <li> Good computer skills, knowledge of Office 365. </li> <li> Excellent communication skills, the ability to communicate regulations and laws to all employees. </li> <li> Critical thinking, assess guidelines and be able to put them into practice. </li> <li> Problem solving, identify risks of noncompliance and ensure these are mitigated and eliminated. </li> <li> Excellent attention to detail. </li> <li> Ability to multi-task, set priorities and manage time effectively. </li> <li> The ability to work independently. </li> <li> Previous legal sector experience is desirable. </li> </ul>The Role <ul> <li> Working hours: 9:00am to 5:30pm, Monday to Friday </li> <li> Location: Clifton Ingram's Wokingham office </li> </ul>The Firm Clifton Ingram is well established and recognised by Legal 500 as a Leading Firm with offices in Farnham, Reading, and Wokingham to cover Berkshire, Surrey, and Hampshire. Our core values of being supportive, responsive, and trusted are important qualities of all colleagues within the firm and feed into the service we deliver to our clients. Staff Type Business Support Staff

6 Business Compliance Jobs in Berkshire, UK