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Director Quality Assurance & Production Management

Medinova AG · Zurich

New
Senior 🇬🇧 English
GMP GDP ISO 13485 Quality Management System (QMS) CAPA

Job description

About the role

Medinova is looking for a Director, Quality Assurance & Production Management to lead its global quality and manufacturing strategy from its headquarters in Zurich Oerlikon. This is a highly visible leadership position with direct impact on the business's growth, compliance and operational excellence, combining strategic leadership with hands-on operational oversight.

Key responsibilities

  • Lead the Quality Assurance & Production Management organization, including personnel leadership, resource planning, budget accountability, KPI management and execution of strategic initiatives.
  • Define and run the global quality and compliance strategy, keeping compliance with GMP, GDP, ISO 13485, regulatory requirements, licenses, certifications and inspection readiness.
  • Own and improve the global Quality Management System (QMS), covering document control, change control, training, deviations, CAPAs, supplier qualification, complaints, risk management and Product Quality Reviews.
  • Drive quality oversight of manufacturing instructions, Master Batch Records, validations, change controls, risk assessments and production documentation.
  • Lead regulatory inspections, internal audits, supplier audits and partner audits, and oversee deviation investigations and CAPAs.
  • Manage the manufacturing network, including CDMO management, manufacturer qualification, manufacturing and technology transfers, and integration of new products and partners.
  • Foster a culture of quality, operational excellence, continuous improvement and safety through leadership, coaching and cross-functional collaboration.

Required profile

  • Degree in Pharmacy, Life Sciences, Chemistry or a related scientific discipline.
  • Qualified Person (QP) certification strongly preferred; Deputy QP experience and potential to take on QP duties highly desirable.
  • Significant leadership experience in pharmaceutical manufacturing, quality assurance and regulated production.
  • Strong manufacturing background and experience managing CDMOs, quality agreements, supplier relationships and manufacturing transfers.
  • Fluent German and English, able to lead stakeholders across Switzerland, Germany and international markets.
  • Willingness to travel up to 50% across multiple European sites.

What we offer

  • Flat hierarchies, open and direct communication.
  • Benefits such as a financial contribution to sports courses and public transport, cultural activities and a meal allowance.
  • Above-average pension fund and private accident insurance.
  • Flexible working hours and a home office arrangement.
  • 25-30 vacation days.
  • Access to the DKSH Fantree Academy for employee development.

Questions fréquentes

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Published 7 hours ago

Expires 1 month from now

4 views · 0 interested

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Medinova AG

Zurich