Manager QA Operations & Responsible Person (RP/FvP)

About the role

Ophtapharm AG is seeking a Manager QA Operations & Responsible Person (RP/FvP) to lead quality assurance in its sterile ophthalmic manufacturing site in Hettlingen, near Winterthur. The role combines strategic oversight with hands‑on execution, ensuring product release, GMP compliance and inspection readiness.

Key responsibilities

• Act as the Responsible Person (RP/FvP) under Swiss regulatory requirements, authorising product release and guaranteeing full GMP compliance.
• Lead and develop the QA Operations team, setting priorities and fostering a high‑performance culture.
• Oversee core QA processes including deviations, complaints, CAPA, change control and risk management.
• Maintain inspection readiness and represent QA Operations during health‑authority inspections and customer audits.
• Drive continuous improvement by monitoring quality metrics, optimising processes and implementing operational excellence initiatives.

Required profile

• MSc or PhD in Pharmacy, Chemistry, Biology or a related discipline.
• Proven experience as a Responsible Person (RP/FvP) for sterile drug products, including interaction with Swissmedic.
• Extensive background in sterile drug product manufacturing within GMP‑regulated environments.
• Demonstrated leadership ability to build and manage high‑performing teams.
• Structured, proactive and solution‑oriented mindset with strong communication skills.

Required skills

• Good Manufacturing Practice (GMP) knowledge.
• CAPA management.
• Risk management and change control.
• Deviation and complaint handling.
• Familiarity with Swissmedic regulatory requirements.

What we offer

• High‑responsibility role with visibility in inspections and audits.
• Opportunity to shape and further develop QA Operations, processes and structures.
• Dynamic environment with short decision‑making paths and close leadership collaboration.
• Flexible working conditions, including partial remote work.
• Attractive employment package with excellent pension scheme, public‑transport accessibility and free parking.