QA Manager

Quality Assurance Manager

Job Type: Permanent | Salary:
Highly attractive |

Location:

Northwest, England

SRG is currently working exclusively with a highly successful, award‑winning contract development and manufacturing organisation focused on providing expert intelligence and support to their partners, driven by their capabilities.

• Ensure full compliance with UK/EU GMP Regulatory Standards and company procedures.
• Lead and manage the Quality Assurance Team at an IMP manufacturing site, focused on Phase I and Phase II clinical trial materials.
• Maintain QA systems and processes, reviewing and supporting ongoing improvement activities.
• Ensure effective management of documents through lifecycle, ensuring compliance with regulations and industry best practices, including creating, reviewing, and approving key documentation such as specifications, SOPs, protocols, and methods associated with all products and procedures.
• Support batch documentation review and provide quality oversight for the certification and release of IMPs by the QP.
• Investigate and approve deviations, complaints and OOS to prevent future reoccurrences of nonconformance, providing support on SMART CAPA plans.
• Supplier Management: manage supplier approval and ongoing performance.
• Evaluate site compliance and implement improvements through the internal audit process, acting as an Internal Auditor and Report approver.
• Represent QA and act as a customer liaison on client projects.
• Support generation and cascade of quality training packages, including GMP induction and annual refresher.
• Assist with management of regulatory inspections: inspection readiness, inspection and response.

• Minimum of 5 years’ recent experience in Quality Assurance within a Pharmaceutical (GMP) facility, preferably Investigational Medicinal Products (IMPs).
• Proven leadership / management experience.
• Degree or equivalent in a relevant scientific discipline desired.
• Experience working with analytical laboratories and/or GMP production areas.