Join a dedicated team at the forefront of GMP manufacturing excellence, where you will lead critical deviation investigations to help ensure the quality, safety, and reliability of life-changing therapies. This is an opportunity to apply scientific expertise, collaborate across multiple functions, and drive continuous improvement in a highly regulated biopharmaceutical environment. The role is primarily based on site in Visp, Switzerland, supporting close, real-time collaboration and technical precision needed to manufacture medicines to the highest quality and safety standards.
Tasks
- Lead and author GMP deviation investigations for manufacturing, cleaning, qualification, and operational events within Module L.
- Conduct structured fact finding, event reconstruction, root cause analysis, impact assessments, recurrence evaluations, and product quality assessments in collaboration with process subject matter experts.
- Partner closely with Operations, QA, MSAT, QC, Engineering, Manufacturing Support, and other stakeholders to define effective corrective and preventive actions (CAPAs).
- Drive deviation records through drafting, review, comment resolution, approval, and closure, ensuring compliance with agreed priorities and timelines.
- Maintain investigation records that are complete, scientifically sound, traceable, inspection-ready, and compliant with GMP requirements and site procedures.
- Support internal audits, customer inspections, and regulatory authority inspections by presenting investigation outcomes, impact assessments, root cause rationale, and CAPA strategies.
- Contribute to deviation reduction initiatives, recurring issue analysis, workload tracking, and the continuous improvement and standardization of investigation practices across the team.
Requirements
- Experience within biotechnology, biopharmaceutical, pharmaceutical, or GMP-regulated manufacturing environments.
- Demonstrated experience leading or supporting deviation investigations, root cause analysis, CAPA management, and quality system processes.
- Strong understanding of GMP requirements, manufacturing processes, cleaning validation, qualification activities, and quality risk management principles.
- Ability to analyze complex technical data, assess product and process impact, and develop scientifically justified conclusions.
- Excellent stakeholder management and communication skills, with the ability to collaborate across Operations, QA, MSAT, QC, Engineering, and Manufacturing teams.
- Degree in Biotechnology, Bioprocess Engineering, Chemical Engineering, Life Sciences, Pharmaceutical Sciences, or a related scientific discipline, or equivalent experience gained in a relevant environment.
- Strong organizational skills with the ability to manage multiple priorities, drive timely execution, and maintain high-quality documentation standards.
Benefits
- An agile career and dynamic working culture.
- An inclusive and ethical workplace.
- Compensation programs that recognize high performance.
- Opportunities to work with highly experienced cross-functional teams in a world-class biopharmaceutical manufacturing environment.
- Professional development through exposure to complex GMP investigations, inspection readiness activities, and continuous improvement initiatives.
- A variety of benefits dependent on role and location.
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