QA Operations Expert – Drug Substance

About the role

The Quality Assurance Operations Expert for Drug Substance will act as a key quality partner at the Aubonne site, overseeing the quality and regulatory compliance of drug substance batches produced internally or externally.

Key responsibilities

• Own end‑to‑end quality oversight of drug substance manufacturing, applying risk‑based compliance.
• Manage deviations, conduct root‑cause analyses, and implement corrective and preventive actions (CAPA).
• Review and approve manufacturing procedures, batch records, and edit Certificates of Analysis.
• Establish Certificates of Conformity for each batch.
• Act as Responsible Person Delegate in line with Swiss regulatory requirements.
• Contribute to monthly quality indicator reviews and lead the Annual Quality Review for on‑site drug substances.

Required profile

• University degree in Pharmacy, Biology, Chemistry or related scientific discipline, or equivalent professional experience.
• Minimum five years of quality assurance experience in the pharmaceutical or biopharmaceutical industry.
• Strong knowledge of Good Manufacturing Practice (GMP) and health‑authority expectations.
• Fluent in French and professionally proficient in English.
• Excellent ownership, attention to detail, and ability to work cross‑functionally.

Required skills

• Good Manufacturing Practice (GMP) compliance.
• Deviation management and root‑cause analysis.
• Corrective and Preventive Action (CAPA) implementation.
• Risk‑based decision making for quality and compliance.