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Quality assurance - gmp&clinical (d/f/m)

Basel
Michael Page International (Switzerland) SA
Inserat online seit: 2 März
Beschreibung

* Globally operating pharmaceutical company
* Temporary assignment for 12-24 months


About Our Client

For our client, a globally renowned pharmaceutical company in the Basel area, we are seeking a Quality Assurance (GMP&Clinical) professional to strengthen the team in 2026 in support of Phase 3 development activities. The contract duration is 12-24 months and is open to candidates with 5+ years of relevant experience across different seniority levels.

Depending on the selected candidate's performance and motivation, the possibility of an extension or a permanent take over.


Job Description

Depending on the candidate`s seniority, the incumbent will provide Quality Assurance oversight for Phase 3 clinical development, ensuring GMP and GCP compliance for clinical trial material and trial execution (small molecules drugs).

* Lead / Support establishment and maintenance of the Quality Management System appropriate for Phase 3
* Own / Contribute to GMP oversight of drug substance, drug product, packaging, labeling, and testing activities
* Manage / Coordinate batch record review, lot disposition, and clinical supply release
* Lead / Support deviation, CAPA, and change control activities impacting Phase 3 material
* Oversee / Participate in vendor and CDMO quality oversight and audits
* Ensure / Support inspection readiness for GMP and GCP inspections
* Lead / Support Quality input to stability programs and expiry management
* Approve / Review quality documentation depending on delegated authority


The Successful Applicant


In order to be considered for the role, the selected candidate must have:

* Degree in Life Sciences disciplines
* Relevant experience in QA phase 3 (small molecules):
o ~5-7 years: Executes QA activities, supports audits/inspections, manages assigned systems
o ~8-10 years: Leads QA activities, acts as primary QA contact for Phase 3 program
o 10+ years: Owns QA strategy, leads inspections, accountable for quality risk
* Strong communication skills in English
* Passion for Drug Development (small molecules)


What's on Offer

The selected candidate will be part of a dynamic team in an international environment and actively contribute to shape, develop, and drive the market authorization of innovative drugs. Hybrid work model (3 days onsite). Extension or take-over possibility.

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