Job Search

Affiliate QA Manager

  • 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

Copyright © All Rights Reserved SEC Life Sciences
Site by Venn