Quality Assurance Manager

4 weeks ago

London, United Kingdom Northreach Full time

Northreach is a dynamic recruitment agency that connects businesses with top talent in the Advanced therapy, fintech, and digital sectors. Our mission is to provide a seamless and personalised recruitment experience for clients and candidates, and to create a positive work environment that encourages equality, innovation, and professional growth.

Job Summary:

As the Senior Manager, Site Quality Assurance, you will play a pivotal role in overseeing and enhancing quality assurance operations at our manufacturing site. Reporting to the Site Leadership Team (SLT), you will lead a team of QA professionals, ensuring compliance with regulatory standards and fostering a culture of continuous improvement.

Key Responsibilities:

  • Manage all site-related QA operations in accordance with Quality Agreements and GMP guidelines.
  • Serve as the QA representative on the Site Leadership Team.
  • Lead adherence to local or corporate Quality Management Systems (QMS).
  • Collaborate in developing the Quell PQS, including implementing an eQMS where applicable.
  • Define and develop new quality processes, policies, and data management systems.
  • Establish and monitor quality standards and metrics to ensure compliance and effectiveness.
  • Utilize quality metrics to mitigate risks, enhance compliance, and improve business processes.
  • Identify and communicate significant quality-related matters or risks affecting product quality and regulatory compliance.
  • Oversee complex QA activities related to manufacturing, testing, and clinical trials, ensuring compliance with regulatory requirements.
  • Manage elements of the PQS pertaining to cellular therapies manufacture, including document control, risk management, training, and audits.
  • Develop, review, and approve Quality and GxP-related documentation.
  • Lead risk assessments and investigations as required.
  • Approve equipment, materials, and services for site use.
  • Conduct external audits as necessary.
  • Provide strategic input into decisions impacting the Quality Assurance department.
  • Deliver QA-related training and basic GMP training as needed.
  • Act as a subject matter expert on Quality-related processes.
  • Lead or represent QA in related projects, identifying metrics, issues, and mitigation strategies.
  • Foster a quality culture of continuous improvement within the team and across the Site Leadership Team.
  • Ensure inspection readiness and support regulatory agency inspections.
  • Recruit, lead, motivate, and develop a team of QA professionals.
  • Support quality-related activities across sites as required.

Minimum Qualifications and Experience:

  • Minimum 10 years' experience in GMP manufacturing, with a focus on QA/Quality roles.
  • Experience in QA support for ATMP manufacture preferred.
  • Demonstrated leadership of small QA teams.
  • Proficient in providing scientifically sound, risk-based quality advice.
  • Extensive experience in writing and reviewing GxP documents.
  • Strong knowledge of GMP principles, sterile production, and regulatory requirements for cell therapy products.
  • Experience in generating and utilizing quality metrics.

Educational Requirements:

  • University degree in a biological science, chemistry, or equivalent field.
  • IRCA Associate Auditor certification desired.

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