Quality Assurance Manager

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.