Senior Quality Assurance Expert – Compliance in Drug Product Services
lonza · Stein
Description du poste
About the role
Drive supplier qualification activities for GMP‑relevant materials, services, and equipment across Basel and Stein, acting as the key interface between Swiss and Indian teams.
Key responsibilities
- Manage qualification and lifecycle of GMP‑relevant suppliers, ensuring compliance with global quality standards and regulatory requirements.
- Serve as primary Quality contact for supplier qualification, collaborating with Supply Chain, Manufacturing, QC, Engineering and other stakeholders.
- Review, approve and maintain supplier documentation, handling complex cases involving quality agreements and compliance.
- Resolve supplier‑related CAPAs, deviations, quality escalations and change requests with global teams.
- Represent Supplier Quality as a Subject Matter Expert during customer audits and authority inspections.
Required profile
- Academic degree or vocational training in chemistry, biology, pharmaceutical sciences or related field.
- At least three years of experience in a GMP‑regulated pharmaceutical environment.
- Proven experience in Quality Assurance or Supply Chain, preferably with supplier management and cross‑functional collaboration.
- Exposure to customer and regulatory audits (e.g., Swissmedic, FDA) is a strong advantage.
- Fluency in English; business‑level German is a plus.
Required skills
- GMP compliance
- Supplier qualification
- CAPA management
- Quality agreements
- Audit participation
What we offer
- Agile career and dynamic work culture
- Inclusive and ethical workplace
- Compensation programs that recognize high performance
- Competitive salary with lifestyle, family and leisure benefits
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