QA Manager

An exciting opportunity has arisen for an experienced Quality Assurance Manager to join an innovative biotechnology organisation developing advanced therapies. This role offers the chance to play a key part in ensuring quality and compliance across both clinical development (GCP) and manufacturing operations (GMP) .

As the Quality Assurance Manager, you will act as the primary Quality partner for Clinical Development and CMC teams, providing oversight of outsourced activities performed by CROs, CMOs, laboratories and other GxP vendors. You'll support inspection readiness, risk management and continuous improvement initiatives while contributing to product development throughout the clinical and manufacturing lifecycle

Key Responsibilities GMP Quality Oversight

• Provide Quality oversight for outsourced manufacturing activities in collaboration with CMC teams
• Review and monitor manufacturing deviations, OOS/OOT investigations and QC activities
• Track CAPAs and Change Controls to ensure timely implementation and closure
• Review GMP documentation including batch records, analytical documentation, specifications, validation documentation and sampling plans.
• Support investigations, quality risk assessments and product quality evaluations.
• Manage and maintain Quality Technical Agreements with manufacturing partners.

GCP Quality Oversight

• Ensure clinical documentation and records are maintained in accordance with regulatory requirements.
• Perform quality review of key clinical documents including protocols, Investigator Brochures, informed consent forms, DSURs and related study documentation.
• Review and monitor Trial Master Files (TMFs) and Sponsor Study Files for completeness and compliance.
• Support clinical risk management activities and mitigation plans.
• Coordinate and support GCP audits of clinical sites, vendors and internal processes.
• Monitor CRO and clinical vendor performance and compliance throughout clinical studies.
• Review protocol deviations, audit findings and CAPAs to maintain study integrity and regulatory compliance.

Quality Management Systems

• Support the implementation, maintenance and continuous improvement of the Quality Management System.
• Contribute to audit and inspection readiness activities.
• Work collaboratively across Quality, Clinical and CMC teams to drive compliance and continuous improvement.

About You

We're looking for a Quality professional with a strong background in both GMP and GCP who thrives in a collaborative, fast-paced biotech environment.

• MSc, Engineering degree, PharmD or equivalent scientific qualification.
• Minimum of 10 years' Quality Assurance experience within the biotechnology or pharmaceutical industry.
• Strong working knowledge of both GCP and GMP regulations.
• Experience developing quality documentation, procedures and QA tools.
• Experience qualifying, overseeing and managing GxP vendors including CROs and CMO's.
• Excellent written and verbal communication skills in English.
• Experience supporting regulatory inspections and GxP audits.
• Background in biologics, advanced therapies, gene therapy or biotechnology products.