QA Director

  • Location

    Hertfordshire, England

  • Sector:

    Life Sciences

  • Job type:

    Permanent

  • Salary:

    Negotiable

  • Contact:

    Carlos Biggemann

  • Contact email:

    Carlos.Biggemann@volt.eu.com

  • Job ref:

    77722-PHARM-CBG_1610110186

  • Published:

    3 months ago

  • Duration:

    Perm

  • Expiry date:

    2021-03-09

  • Start date:

    ASAP

  • Consultant:

    #

Position
*Deputise for Vice President QA and Director QA (US) as required
*Line management responsibility for UK-based QA Managers
*Assist VP QA with QMS design, implementation and maintenance activities
*Ensure that company has a compliant and efficient QA framework and operation to enable GMP activities in company's manufacturing module at the Catapult Cell and Gene Therapy Manufacturing Centre in Stevenage
*Ensure that the company has a compliant and efficient QA framework and operation to enable QA oversight of work executed at third party GxP service providers
*Review annual GxP audit schedules
*Lead complaint investigations and participate in recalls
*Perform self-inspections of activities performed by Systems, Documentation and Training team and assist with audits of other QA departments as required
*Represent QA at CMC project meetings
*Responsible for Site Master File (SMF)
*QA approval of risk assessments and Control Strategies
*Participation in Catapult Collaborator Quality Forums as required
*Chair GxP meetings with operational line managers (GCP, GMP and GLP)
*EU GxP regulatory surveillance
*Ensure efficient operation of the vendor assurance programme and maintenance of the Approved Supplier List
*Support the team as required providing guidance and where necessary technical /QA input into Change Controls, Deviations, OOS reports, investigations and CAPAs
*Lead Quality investigations and perform risk assessments as required
*QA Lead for qualification, validation and technology transfer activities at UK sites
*Conduct external audits of GMP service providers as required
*Conduct internal audits of QMS elements and selected GxP processes as required
*Co-host Competent Authority inspections
*Other QA tasks as required


Requirements
*Educated to degree level or equivalent in a biological or physical science
*Experience in pharmaceutical industry, minimum fifteen years GMP experience of which at least ten must be in a QA role and at least two years' experience working with ATMPs
*Competent Authority (e.g. MHRA, US FDA) inspection experience
*Prior experience auditing contract manufacturers and suppliers
*Excellent planning and organisational skills
*Ability to work in a small team in a dynamic environment
*Significant experience and/ or familiarisation with Microsoft Office applications (specifically Word and Excel)
*Ability to travel to work partners in Europe and US as the role requires
*Excellent working knowledge of ATIMP requirements
*Awareness and understanding of GCP requirements
*Excellent interpersonal skills
*Excellent verbal and written communication and computer literacy skills
*Effective time management
*Strong analytical and problem-solving skills