Quality Assurance, Senior Specialist

Our client is a leading pharmaceutical company with a state-of-the-art production site in the Neuchâtel area, operating globally and ranking among the largest employers in the industry in Switzerland. To strengthen the team, we are looking for an experienced professional as

In this role, you will provide quality oversight for external manufacturing partners involved in the manufacture, packaging, testing, release, and distribution of biological and sterile pharmaceutical products. You will collaborate closely with contract manufacturers as well as internal Quality, Supply Chain, Manufacturing, and Regulatory teams to ensure compliance with international GMP and GDP requirements. Occasional business travel may be required.

• Provide quality oversight for assigned external manufacturing partners and ensure that products are manufactured, tested, packaged, released, and distributed in compliance with regulatory and internal requirements.
• Prepare and review batch release documentation, including executed batch records, certificates, testing documentation, investigations, and change-control assessments.
• Manage quality events such as deviations, complaints, out-of-specification results, change controls, investigations, and corrective and preventive actions.
• Review and approve validation documentation, technical reports, contractor procedures, investigations, and other quality-related records.
• Maintain effective working relationships with external partners, lead quality-related discussions, and monitor the timely completion of agreed improvement measures.
• Support the preparation and review of Quality Agreements and Annual Product Quality Reviews and contribute to quality trend analyses and performance metrics.
• Participate in supplier audits, self-inspections, and health authority inspections while supporting the ongoing development of quality systems, procedures, and working instructions.

• Bachelor's or Master's degree in a scientific discipline or an equivalent qualification.
• At least three years of experience in Quality Assurance within the pharmaceutical or biopharmaceutical industry.
• Practical experience with sterile manufacturing and a solid understanding of pharmaceutical manufacturing and quality operations.
• In-depth knowledge of GMP and GDP requirements applicable to European, US, and other international markets.
• Experience providing quality oversight for external manufacturers or contract manufacturing partners.
• Previous involvement in health authority inspections, ideally with exposure to European or US regulatory authorities.
• Fluent English is mandatory;
  German and/or French language skills are an advantage, combined with strong analytical, communication, organizational, and project management capabilities.