Quality Assurance - GMP&Clinical (d/f/m)
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.
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.
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).
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.
Contact: Kamila Fotiou
Quote job ref: JN-122025-6909327
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