Director GxP Quality Assurance

  1. Permanent
Massachusetts, USA
  1. Quality Assurance, Quality Systems
Posted: 18/04/2024

This vacancy has now expired. Please see similar roles below...

Hobson Prior is seeking a dedicated individual for the role of Director GxP Quality Assurance. The successful candidate will be responsible for developing and maintaining the GMP/GDP specific aspects of the Quality Management System to meet country specific requirements. This role will also involve leading country level inspections, conducting audits, and supporting various quality assurance initiatives.

Please note that to be considered for this role you must have the right to work in this location.

Key Responsibilities

  • For this role you will, develop and maintain the GMP/GDP specific aspects of the Quality Management System to meet US specific requirements.
  • Lead country level inspections.
  • Conduct and oversee audits of GxP vendors.
  • Perform internal audits as required.
  • Provide Quality Oversight of US 3PL vendors, including review of Quality Technical Agreements, attending Quality Meetings, and overseeing GxP quality issues, returns, and destructions.
  • Support recalls and mock recalls.
  • Act as QA assessor/reviewer of GMP/GDP Change Controls.
  • Develop, utilise and continue to mature QA tools.
  • Author/Revise Standard Operating Procedures.
  • Support the wider aims of the QA department.
  • Support initiatives associated with inspection readiness.
  • Support initiatives associated with the design and implementation of the commercial supply chain.


  • Minimum BSc or equivalent.
  • Proven experience working in Quality Assurance (GCP, GMP and GDP compliance).
  • Excellent communication skills with the ability to lead and challenge the status quo.
  • Ability to plan work and prioritise tasks to meet tight deadlines.

Apply now

If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.

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