Head of Quality in Cambridge

We are currently seeking a Head of Quality to lead and manage the strategic and operational performance of our Quality teams.

Advent Bioservices is a Contract Development and Manufacturing Organisation (CDMO) providing GMP manufacturing of ATMPs and related products, process development and ancillary services. We support the development of complex, breakthrough therapies for a globally diverse market. We are at the forefront of revolutionary medicine in which life-threatening diseases are treated using advanced therapy medicinal products.

The Head of Quality will work with the President and Senior Managers to ensure the efficient and effective day to day running of the QA, Validation and QC department, ensuring the design elements and the implementation of the PQS meet the relevant regulatory compliance requirements, managing all activities supporting pharmaceutical product manufacture, testing and certification, as well as being responsible for approving and releasing unlicensed medicine manufactured under Advent's MHRA Specials license.

Key responsibilities will include:

• Lead and implement the company’s quality strategy in line with business goals and GMP/UK regulatory requirements
• Maintain and continuously improve a robust Quality Management System (QMS)
• Champion a culture of quality, compliance and patient safety across the organisation
• Provide quality leadership across commercial, clinical and development stage cell therapy products
• Act as the primary quality regulatory inspections and client audits

Quality and Compliance

• Oversee and enhance the eQMS
• Monitor QMS performance and drive continuous improvement initiatives
• Ensure ongoing regulatory compliance and maintenance of licences
• Lead internal GMP audits, supplier audits and regulatory inspections
• Manage investigations, including deviations, complaints and out of specification results
• Develop and maintain SOP’s, QC protocols and quality documentations
• Analyse and present quality and operational performance data

Technical and QC Oversight

• Oversee QC operations for ATMP’s including testing, validation and release activities
• Approve raw materials, packing components and finished products
• Manage environmental monitoring and microbiological control programmes
• Ensure validation of analytical methods, equipment and laboratory systems
• Oversee stability programmes, sampling plans and contract testing
• Provide QC guidance and support to manufacturing teams

Validation and Equipment

• Ensure validation strategies for facilities, utilities and equipment comply with regulatory standards
• Support validation activities across production and QC
• Oversee maintenance, qualification and compliance of laboratory environments and equipment

Leadership and Management

• Lead QA, QC and Validation teams
• Drive companywide training and awareness of quality systems
• Support senior leadership and business development activities
• Provide strategic oversight across quality and operational functions

Regulatory and External Engagement

• Act as main contact for regulatory authorities, clients and external partners
• Support Qualified Person (QP) activities
• Ensure compliance with MHRA, GMP, ATMP and HTA requirements

The successful candidate will have the following experience/qualifications:

• MSc in relevant scientific discipline (Pharmaceutical Sciences, Biotechnology, Biochemistry) or equivalent.
• Significant experience working as a senior quality manager within a GMP Quality department in the manufacture of cell and/or gene therapy products
• Experience of liaison with regulatory authorities (HTA and MHRA)
• Experience in establishing and maintaining a Contamination Control Strategy
• Experience of validation of facilities and equipment
• Demonstrated knowledge of Quality Control, Quality Assurance, validation, GMP, MHRA Regulatory Compliance and testing and packaging of ATMPs
• Ability to interpret complex data and present key findings
• Good documentation practice and QC reporting
• Experience of microbiology and analytical methods in cell therapy

This is a fantastic opportunity to join a growing organisation. We offer an attractive base salary and benefits package. Candidates must have the eligibility to work within the UK. We are not accepting agency applications for this position.