We are looking for a Quality Management Lead - Commercial Quality, Mechelen
Scope of the job: The Quality Management Lead - Commercial Quality will be responsible for the operational management of the quality processes related to the commercial GMP activities. In this role, you will be working closely with internal partners (Quality Management, New Product Introduction, Supply Chain, Regulatory, etc.) and external partners/vendors (Contract Manufacturing and Packaging Organizations).
Your role:
* Ensure adequate vendor quality oversight: quality review of executed batch records, deviation and change control support, external audit follow-up, and management of CMO/CPO Quality Agreement(s).
* Be the Quality Lead for appointed vendors in Drug Substance, Drug Product, and Packaging.
* Manage Product Quality Complaints and Service Complaints.
* Drive the processes related to Quality Management Review, Annual Product Quality Review, Quality Risk Management, and (mock) recalls.
* Provide support during regulatory inspections.
* Participate as appointed in (improvement) projects related to commercial GMP activities.
* Provide continuous GMP compliance support by acting as an internal Quality advisor on the key quality systems and procedures to ensure correct interpretation and implementation.
* Build collaborative working relationships with cross-functional peers and advocate a Quality culture and mindset.
Who are you?
* You have a master's degree in a scientific discipline or equivalent education.
* You have a minimum of 5 years' experience within the Pharmaceutical Industry (preferably QA) with proven knowledge and experience in GMP & regulatory requirements.
* You have a good understanding of the end-to-end pharmaceutical and supply chain lifecycle.
* You possess efficient problem-solving, decision-making, and analytical thinking skills.
* You have good interpersonal skills resulting in an effective (intra- and cross-departmental) team player.
* Auditing and Regulatory Authority inspection experience is considered a plus.
* ATMP knowledge is a plus.
Contact Gilles Carpentier .
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