Biosynth
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.
Deputy QA Site Lead / Senior Quality Assurance Officer (m/w/d)
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.
We offer
Biosynth ® offers a number of benefits, including:
- A varied and responsible position, working for a global company
- Attractive and comprehensive employee benefits package
- Competitive wages
- Flexible schedule and holiday arrangements.
- Generous parental leave
- Free parking and good transport connections
Arbeitsort: 9422Staad
Biosynth
Rietlistrasse 4
9422 Staad