QA Manager / Senior QA Manager

Our Company:
AviadoBio is on a mission to to transform the lives of people living with neurodegenerative disorders through the development of cutting-edge gene therapies - and we're looking for an experienced and driven Quality Assurance Manager to champion our quality systems within a fast paced, GxP regulated environment.

The Role:

Siting within the Quality Assurance team, this is a pivotal role responsible for ensuring that our operations, processes, and products consistently meet the highest regulatory standards across GMP and GCP frameworks.

As a member of the QA function, you will be instrumental in maintaining our culture of quality, driving continuous improvement initiatives, and serving as a key point of contact for QA activities. You will collaborate cross-functionally with Manufacturing, R&D, Regulatory Affairs, and Supply Chain.

Responsibilities will include:

Quality Management Systems

• Maintain, and continuously improve the Quality Management System (QMS) in line with GxP requirements and ICH guidelines to drive continuous improvement
• Oversee the management and release of SOPs and quality records, ensuring timely review and version control
• Lead the Event, Change Control, CAPA, and Deviation processes from initiation through to closure on behalf of QA
• Manage the SOP process to ensure timely release of procedures and staff adherence, maintaining a state of compliance
• Ensure quality oversight of manufacturing, supply chain, nonclinical and clinical activities to maintain compliance and mitigate risk
• The successful candidate will have overall responsibility of the eQMS, keeping it up to date with all its relevant records and documentation

Auditing & Supplier Quality

• Plan and conduct internal and vendor GxP audits, tracking findings and ensuring timely CAPA closure
• Assist in the management of the approved supplier/vendor qualification programme, including qualification audits and ongoing monitoring
• Review and approve supplier quality agreements and technical agreements

Product & Process Quality

• Provide QA oversight and approval for critical GxP documentation
• Assist in designing and allocating QA training to build quality knowledge across the organization, strengthening the quality culture
• Ensure GxP training compliance to meet regulatory requirements
• Maintain SOP training matrix to ensure staff competency on current procedures, enabling consistent execution

We are open to candidates at Manager or Senior Manager level — the role and title will be scoped to reflect the experience of the successful candidate

• Degree (or equivalent) in a Life Sciences, Chemistry, Pharmacy, or related scientific discipline
• Extensive QA experience within a GxP-regulated industry (pharmaceutical, biotech, medical devices, or CDMO)
• Demonstrated experience managing regulatory authority inspections
• Excellent working knowledge and experience in a GMP environment
• A good working knowledge of GxP regulations and relevant ICH guidelines
• Extensive experience managing eQMS processes including Events, CAPA, change control, deviations, and document management
• Excellent written and verbal communication skills, with the ability to present to senior stakeholders and regulatory bodies
• Flexibility and the ability to adapt quickly in a fast-paced environment
• Ability to identify and mitigate compliance risks
• Excellent project management and organizational skills
• Demonstrated team engagement and people management capabilities
• Strong problem-solving and decision-making skills
• Experience supporting clinical trial operations and IMP release
• Experience within an ATMP, biologics, or sterile manufacturing environment
• Lead Auditor experience

• Competitive Salary
• Annual Bonus
• Season Ticket Loan
• Exciting Equity Plan
• Pension Scheme
• Private Healthcare
• Fantastic Maternity Leave policy
• Childcare/Nursery scheme
• Cycle to Work scheme
• Discount club
• Gym benefits
• Electronics Benefits
• Income protection