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.

Typical responsibilities/accountabilities:

• 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 life-cycle, 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 re-occurrences of non-conformance, 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.

Essential Requirements:

• Proven Leadership/ Management experience in Quality Assurance within a Pharmaceutical (GMP) facility.
• Degree or equivalent in a relevant scientific discipline
• Experience in working with analytical laboratories and/ or GMP production areas.
• Experience with Investigational Medicinal Products (IMPs) would be advantageous.

SRG are the UK number 1 recruitment company specialising in the science, engineering, clinical, pharmaceutical, food/FMCG, renewable, biotech, chemicals and medical devices sectors.

As scientists ourselves, our specialist sector knowledge and our passion are second to none. It's this combination that makes us different. We're committed to providing outstanding temporary, contract and permanent career opportunities of all levels for our candidates and a comprehensive range of expert strategic recruitment services for our clients.

If you have a scientific background and this position is not relevant / suitable for you please feel free to get in touch or visit www.srg.co.uk to view our other vacancies.

Guidant, Carbon60, Lorien & SRG - The Impellam Group Portfolio are acting as an Employment Business in relation to this vacancy.