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Quality Assurance Manager
Job summary
A leading CDMO in the pharmaceutical sector is seeking a Quality Assurance Manager to join their team in Manchester. This role involves ensuring compliance with UK/EU GMP standards, leading the QA team at an IMP manufacturing site, and maintaining QA systems. The ideal candidate will have over 5 years of experience in Quality Assurance within a pharma environment, provide quality oversight for product certification, and manage supplier performance. This position offers a unique opportunity for professional growth in a fast-paced environment.
Qualifications
- Minimum of 5 years of recent experience in Quality Assurance within a Pharmaceutical (GMP) facility, preferably with IMPs.
- Proven leadership and management experience.
- Experience working with analytical laboratories and/or GMP production areas.
Responsibilities
- Ensure compliance with UK/EU GMP Regulatory Standards and procedures.
- Lead the Quality Assurance Team at an IMP manufacturing site.
- Maintain QA systems and processes.
- Manage documents through their lifecycle for compliance.
- Review batch documentation and provide quality oversight for IMP certification.
- Investigate deviations and provide support on CAPA plans.
- Manage supplier approval and performance.
- Conduct internal audits and implement compliance improvements.
- Support client projects as a QA representative.
- Provide quality training sessions.
- Assist with regulatory inspections.
Skills
Education
Are you an experienced Quality Assurance Leader looking for a challenge with a really exciting CDMO focused on Pharmaceutical Manufacturing?
Job Title: Quality Assurance Manager
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.
As a result of expansion, we are looking for a Quality Assurance Manager to join their quality team.
- 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. This includes - 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.
- Investigating and approval of deviations, complaints and OOS to prevent future reoccurrences of nonconformance, providing support on SMART CAPA plans.
- Supplier Management: Managing supplier approval and ongoing performance.
- Evaluating site compliance and implementing improvements through the internal audit process, as an Internal Auditor and Report approver.
- Supporting Client projects as a Quality Assurance representative and Customer liaison
- Support generation and cascade of quality training packages, including but not limited to GMP induction and annual refresher.
- Assist with management of Regulatory inspections: inspection readiness, inspection and response.
- Minimum of 5 years' of 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 in working with analytical laboratories and / or GMP production areas.
* The salary benchmark is based on the target salaries of market leaders in their relevant sectors. It is intended to serve as a guide to help Premium Members assess open positions and to help in salary negotiations. The salary benchmark is not provided directly by the company, which could be significantly higher or lower.