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Affiliate QA Manager

PR/156226_1717418578
  • Negotiable
  • Allschwil, Basel-Country
  • Permanent

Join a leading global player in the pharmaceutical industry as a Commercial Affiliate QA Manager (GMP/GDP). This role offers an exciting opportunity to drive Quality and Regulatory Compliance across European affiliates. You will be integral to developing and implementing a standardised QMS aligned with headquarters' quality assurance requirements, ensuring adherence to GMP and GDP for products within the supply chain.



Your Role as Commercial QA Manager

  • Develop and maintain compliance of the Affiliate Quality Management Systems (QMS) with company policies, industry standards, and local GMP/GDP regulations.
  • Manage affiliate documentation and training records, collaborating with HQ QA for alignment and consistency.
  • Handle non-conformances related to GxP: deviations, change controls, CAPAs, and Quality Events.
  • Monitor quality system performance using relevant metrics, ensuring alignment with HQ QA guidance.
  • Notify HQ QA and stakeholders of substantial concerns regarding product quality, safety, and compliance.
  • Support external audits and inspections, ensuring the affiliate's readiness for planned and ad hoc audits.
  • Ensure local PV-related vendors/external partners are qualified and monitored.
  • Conduct GxP-related self-inspections and internal audits as necessary.


Experience and Qualifications for the Commercial QA Manager Role

  • Graduate degree in Pharmacy, or related scientific/health field (BSc minimum); additional knowledge in Quality Assurance/Compliance and Auditing.
  • Fluency in English, both written and spoken; intermediate knowledge of French is a plus.
  • Minimum of 5 years of experience in the pharmaceutical industry in QA and PV fields, including GDP for commercial products and GMP.
  • Experience in regulatory inspection management and interactions with health authorities.
  • Qualified Person (QP) experience is a plus.
  • Strong organisational skills with the ability to manage multiple priorities and timelines.
  • In-depth knowledge of GMP/GDP requirements and PV regulations, including product complaint and recall management.


Apply Now
If you are ready to take on this pivotal permanent role and drive quality assurance in a leading pharmaceutical company, apply now for immediate consideration. For similar opportunities in the sector, feel free to reach out directly.

Isobel Abernethy Associate Consultant, Quality Assurance

Apply for this role

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