Senior Quality Assurance Specialist – Neuchâtel (12‑month contract)

About the role

We are seeking an experienced Quality Assurance Senior Specialist to provide oversight for external manufacturing partners producing biological and sterile pharmaceutical products. The role involves close collaboration with contract manufacturers and internal teams to ensure compliance with international GMP and GDP standards.

Key responsibilities

• Provide quality oversight for assigned external manufacturing partners, ensuring compliance with regulatory and internal requirements.
• Prepare and review batch release documentation, including batch records, certificates, testing documentation, investigations, and change‑control assessments.
• Manage quality events such as deviations, complaints, out‑of‑specification results, investigations, and corrective and preventive actions.
• Review and approve validation documentation, technical reports, contractor procedures, and other quality‑related records.
• Support supplier audits, self‑inspections, and health authority inspections while contributing to the development of quality systems.

Required profile

• Bachelor’s or Master’s degree in a scientific discipline or equivalent qualification.
• At least three years of Quality Assurance experience in the pharmaceutical or biopharmaceutical industry.
• Practical experience with sterile manufacturing and solid understanding of pharmaceutical manufacturing operations.
• In‑depth knowledge of GMP and GDP requirements for European, US and other international markets.
• Fluent English; German and/or French language skills are an advantage.

Required skills

• GMP
• GDP
• Batch release documentation
• Sterile manufacturing processes