The actual location of this job is in Stein, AG, Switzerland. Relocation assistance is available for eligible candidates and their families, if needed. Be part of an exciting project-phase team driving operational readiness from a Quality perspective, ensuring robust documentation, SOP compliance, aseptic process preparedness, and effective deviation and CAPA oversight. This role offers the chance to influence how future manufacturing operations are established, making it an ideal step for professionals looking to transition from production into Quality Assurance. This role is primarily based on site. Working together in person supports close, real‑time collaboration and the technical precision needed to manufacture medicines to the highest quality and safety standards. Flexibility to work remotely for no more than 20% of your time is offered, with requests considered on a case‑by‑case basis, in line with business needs.
Tasks
- Provide QA oversight for shopfloor manufacturing activities within a growth project, ensuring compliance with GMP requirements and operational readiness.
- Review and approve SOPs, work instructions, and other GMP documentation to support successful start-up and sustainable manufacturing operations.
- Partner with Manufacturing teams to drive aseptic process readiness, including preparation, training support, and execution readiness for APS and future media fill activities.
- Lead and coordinate quality events by reviewing and approving deviations, CAPAs, investigations, and related quality records, ensuring timely and effective resolution.
- Act as the Quality representative during project discussions, audits, and inspections, clearly communicating the quality oversight strategy and supporting inspection readiness.
Requirements
- Proven experience in the pharmaceutical industry within a GMP-regulated environment, with expertise in sterile and/or drug product manufacturing is a must.
- Experience in quality oversight, management of deviations, CAPAs, and investigations.
- Fluent German and fluent English communication skills are essential, enabling effective collaboration with shopfloor operators, cross-functional teams, customers, and regulatory authorities.
- Willingness to spend significant time on the manufacturing shopfloor, including working in full aseptic gowning, and a hands-on approach to supporting operations and driving quality excellence is a must.
- Bachelor's, Master's, or PhD degree in Life Sciences, Pharmacy, Chemistry, Biology, Biotechnology, or a related field, combined with a pragmatic, solution-oriented mindset, strong stakeholder management skills, and the agility to thrive in a dynamic greenfield project environment.
- Experience supporting regulatory and customer audits and inspections is an advantage.
Benefits
- An agile career and a dynamic work culture.
- An inclusive and ethical workplace.
- Compensation programs that recognize high performance.
- In addition to a competitive salary, you can expect numerous lifestyle, family, and leisure benefits.
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