Quality Assurance Manager

SRG; Manchester; On-site; GBP 80,000 - 100,000; Full time

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

Quality Assurance leadership

GMP Compliance

Team management

Regulatory inspections

Education

Degree in a relevant scientific discipline

Job description

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 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.

Essential Requirements :

• 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.