Deputy QA Site Lead / Senior Quality Assurance Officer (m/w/d)

Deputy QA Site Lead / Senior Quality Assurance Officer (m/w/d)

We take great pride in our vast range of chemical and biochemical products, and our high standards are maintained through great people, who share our values, and want to do the very best job possible, every day.

We acknowledge the important part our team members, who are based over three continents with manufacturing laboratories in Switzerland, the United Kingdom, Slovakia and China, and distribution centres in the United States, play, in our continued success.

About the Role

We are seeking a Deputy QA Site Lead and Senior Quality Assurance Officer to strengthen our QA team at our GMP and ISO 9001 certified chemical production site in Staad. The role combines operational QA responsibilities with leadership duties, acting as deputy to the QA Lead and supporting global cross-site projects.

This position requires a strong grasp of GMP and ISO standards in a vibrant CDMO environment, the ability to manage complex quality matters independently, and the leadership to drive audits, compliance, plant qualification projects, and continuous improvement initiatives.

Key Responsibilities

• Act as Deputy QA Site Lead, supporting and substituting for the QA Lead in day-to-day operations and decision-making.
• Ensure compliance with GMP and ISO 9001 requirements across all QA activities at the Staad site.
• Lead, coordinate, and support internal and external audits, including customer audits and authority inspections.
• Manage QA oversight of production, laboratory, and supply chain operations in a CDMO environment.
• Drive qualification, validation, and compliance projects, including plant and equipment qualification.
• Collaborate with global QA and cross-site teams to align processes, implement best practices, and contribute to strategic initiatives.
• Provide guidance and training to QA team members and other departments on quality matters.
• Identify, implement, and monitor continuous improvement initiatives within the QA system.
• Prepare, review, and approve QA documentation such as SOPs, CAPAs, deviations, and change controls.
• Serve as key contact for quality-related questions, risk assessments, and decision-making on complex issues.

Requirements

• University degree in chemistry, pharmacy, biology, or related natural sciences, or equivalent qualification.
• Several years of professional experience in QA within a GMP-regulated environment, ideally in chemical production or a CDMO setting.
• In-depth knowledge of GMP and ISO 9001 requirements and proven ability to apply them pragmatically.
• Strong track record in audits, inspections, and compliance oversight.
• Experience in qualification/validation projects and knowledge of computerized system validation is an advantage.
• Leadership experience or strong leadership potential, with the ability to motivate and develop team members.
• Excellent communication skills in English and German.
• Analytical and structured working style with strong problem-solving abilities.
• High level of independence, reliability, and resilience in a dynamic environment.

About us

Biosynth is an innovative life sciences reagents, custom synthesis and manufacturing services company headquartered in Staad, Switzerland. We are by scientists, for scientists, securing supply chains with consistent quality, across the globe. As a trusted supplier, manufacturer and partner to the pharmaceutical, life science and diagnostic industries, as well as food, agrochemical and cosmetic customers, we have facilities on three continents and a rapid global distribution network. Our main production laboratories are located in Switzerland, the UK, Slovakia and China, with peptide and antibody production in the US, the UK and the Netherlands. Enzyme projects are based in Austria, bioconjugation projects in Germany and biological IVD reagents in Ireland.

Deputy QA Site Lead / Senior Quality Assurance Officer (m/w/d)