QA Manager Drug Product klinische Herstellung

Senior Quality Assurance Specialist – IMP Quality Operations (Synthetic Molecules)

📅
Start Date: February 1, 2026 (latest March 1, 2026)

📄
Contract Duration: 12 months (high likelihood of extension)

💼
Workload: 100% |
Home Office: up to 20%

About the Role

The Synthetic Molecules IMP Quality Group ensures quality oversight for Synthetic Molecules Drug Substance and Drug Product operations, including associated quality control. As part of the IMP Quality Organization Switzerland
, you will ensure compliance and continuous improvement of GMP standards for the Drug Product IMP manufacturing site in Basel.

Key Responsibilities

• Review Drug Product Batch Records in collaboration with relevant departments
• Perform IMP Drug Product release
• Review and approve GMP documents (specifications, risk assessments, deviation reports, change control records)
• Approve cleaning protocols and reports
• Provide GMP-related support to operational departments
• Conduct self-inspections and support audits

Must-Haves

• Master’s degree in a scientific discipline
• 10+ years of experience in the pharmaceutical industry, including at least 5 years in Quality Assurance
• Strong knowledge of cGMP and quality requirements for clinical development phases
• Proven success in health authority inspections and internal GMP audits
• Fluent in German and English (written and spoken)

Nice-to-Have

• Experience in pharmaceutical development (Synthetic Molecules Drug Product)

👉
Interested? Apply now and join a dedicated team ensuring the quality of clinical trial materials!