Quality Assurance Manager - ATMPs

Stevenage, Hertfordshire, South East, England

Posted:14 days ago
Location:Stevenage, Hertfordshire, South East, England
Job Ref:BH-33754
Job Type:Contract
Expiry date:12/6/2022
Contact:Audwin Cheung
Contact Email:audwin.cheung@source-technology.com
Xplore life sciences are recruiting for a QA Manager with specialist knowledge of Advanced Therapy Medicinal Products (ATMPs) and GMP relating to aseptic environments.
The role will require the successful candidate to lead establishing a risk based Pharmaceutical Quality System (PQS) to enable compliant manufacture and testing of Advanced Therapeutic Medical Products as directed by the Senior Director, QA. They will help build and then manage a small team of QA professionals.
  • To provide Quality support to manufacturing operations and quality control, manufacturing and testing cell therapy products for clinical use based within a shared GMP manufacturing centre
  • Manage and perform routine QA duties to ensure manufacturing, testing and clinical trials activities comply with GMP, GCP, HTA and other regulatory requirements relating to manufacture and clinical trials for cellular therapies and ATMPs including:
    • Document control system
    • Training system
    • Change controls
    • Corrective and preventative actions (CAPA) o Deviation & OOS reporting
    • Complaint and recall handling o Calibration and maintenance o Qualification & validation
    • Internal audits
    • Vendor qualification
    • Batch record review prior to QP release
  • Act as the point of contact for Quality related activities as required by Quality Technical Agreements with contract partners
  • Draft, review and approve Quality and GxP related documentation
  • Facilitate or perform risk assessment and investigations as required
  • Manage Product Specification Files for ATIMP’s
  • Advise the Quell manufacturing and QC teams on Quality related issues
  • Advise and assess the quality and suitability of equipment, materials and services for their intended purpose. Perform external audits as necessary.
  • Monitor for trends and the effectiveness of the quality management systems including developing and producing KPI’s and Quality Metrics
  • Inform Head of Quality and Senior Management of significant quality related matters or risks that could impact product quality, product release or regulatory compliance.
  • Recruit, manage and develop QA team to meet needs of business
  • Promote quality culture and one of continuous improvement within team
  • Organize and deliver QA related training and deliver basic GMP training
  • Provide general quality support for other functions within the business e.g. R&D / clinical trial sample testing / process development teams as required
  • University degree in a biological science, pharmacy, chemistry or equivalent 
  • Min 8 years’ experience or equivalent experience working in a Quality Assurance role in a GMP environment
  • Experience with supporting the manufacture of ATMP’s
  • Experience of writing and/or review of GxP documents (including SOPs, qualification/ validation reports and batch records) to ensure good documentation , data integrity, GxP, quality and regulatory requirements are met
  • Experience of leading or facilitating investigations including root cause analysis
  • Experience of auditing
  • Expert knowledge of GMP relating to sterile production, cleanrooms, aseptic technique and hygienic requirements for sterile products
  • A working knowledge of regulatory requirements that specifically apply for the manufacture and/or testing of cell therapy products and/or ATMP’s
  • Demonstrated experience in developing a PQS especially involving an eQMS
  • Exemplary attention to detail and record keeping demonstrating good documentation practices
  • Excellent interpersonal and English language communication skills (written and verbal)
  • Capable of managing a wide range of tasks, managing own time effectively and prioritising tasks for self and team accordingly
  • Experience of managing and developing staff within a small team
  • Ability to work with integrity, to high ethical standards with an open-minded pragmatic approach

Apply now