Senior Quality Assurance and Regulatory Compliance Officer

By joining Bio-Techne, you'll join a company with a powerful and positive purpose of enabling cutting-edge research in Life Sciences and Clinical Diagnostics. Bio-Techne, and all of its brands, provides tools for researchers to further treat and prevent disease worldwide.

Reports To: QA and regulatory Compliance Team Leader

Location: On-site in Bristol, UK

Work type: Full-time (37.5 hours)

Position Summary

Bio-Techne is a world-leading developer and manufacturer of high quality life science reagents and is seeking a Senior QA Compliance Officer to join their growing team in their QA department in Bristol.

This successful candidate will join a vibrant and dynamic Quality Assurance team, working alongside the QA Compliance Team Leader, to coordinate and lead Quality Assurance tasks relating to ensuring compliance to the QMS and GMP regulations for products manufactured on the Bristol site. The Senior QA Compliance Officer will mentor and coach other QA Compliance Officers in QA Compliance requirements and business practices.

Reporting to the QA Compliance Team Leader the Senior QAC Officer will be a highly collaborative and proficient individual with excellent communication skills.

This is an exciting opportunity for a Senior QA Compliance Officer to help lead and maintain the current Quality Systems as well as get involved in continual improvement of these systems.

Key Responsibilities

• Leading activities that support ensuring site compliance with the ISO 9001:2015 QMS, EurdraLex Volume 4 Part II GMP regulations and other applicable legislation, by working closely with internal colleagues from all departments to ensure compliance requirements are recognised, understood and maintained.
• Assist with planning and scheduling activities in relation to Quality System internal audits across the Bristol site. Participate in the completion of internal audits in compliance with ISO 9001:2015 and applicable GMP regulations. Mentor and coach internal auditors.
• Oversight and administration of the Documentation Control system
• Lead Non-conformance system activities. Coordinate, approve and manage to completion Non-Conformances/Corrective Actions, working closely with colleagues from all areas to ensure items are effectively managed and closed in a timely manner. Ensure adequate root cause investigations are conducted. Identify NC trends and communicate these to quality and operational leaders.
• Lead Change Control and Deviation activities. Coordinate, assess, approve and manage to completion change controls and deviations, working closely with colleagues from all areas to ensure items are effectively managed and closed in a timely manner.
• Input into the Customer Product Complaint process for the Bio-Techne Bristol product portfolio.
• Gathering and analysing Quality Systems data, including assessment against KPIs to ensure the effectiveness of the Bristol QMS.
• Responsible for creating, maintaining and continually improving standard operating procedures (SOPs) to ensure compliance is met and maintained.
• Participate in customer and regulatory audits, including leading preparation activities, during the audit and any follow up activities.
• As required, participate in applicable meetings as the QA Compliance representative and serve as a contact for internal and external customer compliance matters for Bio-Techne Bristol products.
• Lead QA related training sessions for new starters and ongoing refresher training sessions for the business.
• Coordinate the QA Training Matrix to ensure it is up to date and training records have been completed as required.
• Regulatory Compliance activities related to Controlled Drugs.
• Provide cover for Supplier Quality and QA Batch Release Team, when required.
• Work closely with Quality, Manufacturing, Operations and Facilities teams to identify and support Quality System compliance and customer needs.
• Coach and mentor team members on QA Compliance and business requirements including best practices.
• Foster and support a culture of high performance, teamwork and exhibiting Bio-Techne's EPIC values.
• Perform additional duties as assigned.

Education and Experience

Essential:

• BSc/BA degree in biology, chemistry, biochemistry, bioengineering, or a related life science field.
• A high level of experience working within a Quality Assurance or Quality Systems function for a Pharmaceutical, Medical Device, Life Science or Biotechnology company.
• Experience of working within a cGMP environment.
• Experience of working to EudraLex Volume 4, Part II or to 21CFR part 820.
• Experience of working to ISO 9001 or ISO 13485.

Desirable:

• Experienced internal auditor for ISO 9001/ISO 13485 and cGMP.
• Experienced in investigation of customer complaints and customer technical support.
• Experience with Customer and Regulatory audits.
• Experienced in the critical review of CAPA / non-conformances / deviations.
• Experience of data analysis against KPIs and reporting trends to Top Management.
• Experienced in documentation management systems and change control processes from a Quality Assurance perspective.
• Experience of Supplier Quality processes.

Personal Qualities and Attributes:

• Excellent team working skills
• Ability to critically review documentation
• Methodical, process orientated and highly organised
• Excellent attention to detail
• Excellent time management skills
• Excellent verbal and written communication skills in English
• Problem solving ability
• Flexible with a can-do attitude

Bio-Techne is committed to product quality, customer satisfaction, continued improvement, minimising environmental impacts and conserving natural resources. Environmental and quality management is an integral core value and vital part of the Bio-Techne culture.

Why Join Bio-Techne:

• We offer competitive wages along with extensive benefits for employees and their families.
• We invest in our employees' financial futures through retirement programs and an employee stock purchase plan.
• We help our employees develop their careers through mentorship, promotional opportunities, training and development, internship programs, and more.
• We offer an international and diverse working environment, enriched by employee resource groups; volunteer and charity events; and employee events that build a culture of caring and belonging.
• We foster a culture of empowerment and innovation, where employees feel valued and encouraged to bring their new ideas to the table.

Bio-Techne 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, disability, or status as a protected veteran.

To protect the interests of all, Bio-Techne will not accept unsolicited resumes from any source other than a candidate application. Any unsolicited resumes sent to Bio-Techne will be considered Bio-Techne property.