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Quality Assurance Manager
Aspeya · Lausanne
Description du poste
About the role
Aspeya is seeking an experienced Quality Assurance Manager to lead product quality performance across its external manufacturing network. You will be the primary quality representative, ensuring that products meet the highest standards from development through commercial supply.
Key responsibilities
- Provide quality support for product development and launch readiness, including market entry assessments.
- Support commercial product supply by identifying risks, escalating issues, and driving mitigation plans.
- Represent Quality in cross‑functional projects as the main point of contact for all quality‑related matters.
- Conduct supplier qualifications, perform regular product‑specific and quality system audits, and manage the Approved Suppliers List.
- Close non‑conformances, support supplier approvals, and travel to supplier sites as needed.
- Manage complaints, deviations, and investigations for commercial batches, ensuring robust root‑cause analysis and CAPA implementation.
- Review supplier change controls, ensure regulatory alignment, and monitor ongoing compliance.
- Develop and track KPIs for supplier performance and product quality, identify improvement opportunities, and lead structured problem‑solving activities.
Required profile
- Strong experience in quality management within regulated industries such as pharmaceuticals, medical devices, or FMCG.
- Proven track record managing external suppliers and manufacturing partners.
- Experience leading investigations, deviations, CAPA, and change‑control processes.
- Deep understanding of quality systems, audit processes, and regulatory requirements.
Required skills
- Quality Management Systems (QMS)
- Supplier qualification and auditing
- CAPA (Corrective and Preventive Action) management
- Root‑cause analysis
- Regulatory compliance (pharma/medical device standards)
- KPI development and monitoring
What we offer
- Opportunity to work in a dynamic, future‑thinking environment.
- Impactful role contributing to healthier lifestyles and patient outcomes.
- Collaboration with cross‑functional teams and global partners.
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Aspeya
Lausanne
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