Director Quality Assurance & Production Management

Medinova AG; Zürich; Vor Ort; CHF 250.000 - 350.000; Vollzeit

Benefits dieser Stelle

Fringe benefits: sports & cultural

Pension plan & private accident cover

Flexible working hours & home office

25–30 vacation days

Zusammenfassung

Medinova AG in Zürich seeks an exceptional Director, Quality Assurance & Production Management to shape our global quality and manufacturing strategy. Based at our Zürich Oerlikon headquarters, this senior role blends strategic leadership with hands-on operational oversight across international sites.

You will drive the QMS, ensure GMP/GDP/ISO compliance, and oversee regulatory inspections, audits, and CDMO partnerships, while leading a diverse team and managing budgets.

Qualifikationen

• Degree in Pharmacy, Life Sciences, Chemistry or related field.
• Qualified Person (QP) certification strongly preferred; Deputy QP is desirable.
• Extensive leadership in pharmaceutical manufacturing, QA and regulated production.

Aufgaben

• Lead the Quality Assurance & Production Management organization, with budgeting, KPI and strategic initiatives.
• Define and drive global quality and compliance strategy across GMP, GDP, ISO 13485 and regulatory requirements.
• Own and improve the global QMS: document control, change control, training, deviations, CAPAs, supplier qualification and PQRs.
• Oversee manufacturing processes, Master Batch Records, validations, change controls and risk assessments.
• Lead regulatory inspections, internal and supplier audits with effective remediation and continuous improvement.
• Direct deviation, investigation and CAPA activities with robust root-cause analysis.
• Translate evolving GMP/GDP/ISO requirements into practical business processes.
• Oversee manufacturing network performance, CDMO management and technology transfers.
• Promote a culture of quality, operational excellence and safety through leadership and collaboration.

Kenntnisse

Leadership

Quality mindset

Cross-functional collaboration

Regulatory knowledge

Strategic thinking

Budget management

KPI management

Risk management

Training & coaching

Ausbildung

Degree in Pharmacy/Life Sciences/Chemistry

Qualified Person (QP) certification

Jobbeschreibung

Medinova is seeking an exceptional Director, Quality Assurance & Production Management to lead and shape our global quality and manufacturing strategy. Based at our headquarters in Zurich Oerlikon, this is a highly visible leadership position with significant influence across the organization and direct impact on the future growth, compliance, and operational excellence of the Medinova business.

This role combines strategic leadership with hands‑on operational oversight and is ideally suited to an experienced Quality or Manufacturing leader who thrives in complex international environments.

If you are an accomplished pharmaceutical quality and manufacturing leader who thrives on ownership, challenges convention, and delivers meaningful results, we invite you to play a pivotal role in shaping Medinova's future growth and success.

What You Will Deliver

• Lead the Quality Assurance & Production Management organization, including personnel leadership, resource planning, budget accountability, KPI management, and execution of strategic business initiatives.
• Define and execute the global quality and compliance strategy, ensuring continued compliance with GMP, GDP, ISO 13485, regulatory requirements, licenses, certifications, and inspection readiness.
• Own and continuously improve the global Quality Management System (QMS), overseeing key quality processes including document control, change control, training, deviations, CAPAs, supplier qualification, complaints, risk management, and Product Quality Reviews.
• Drive quality oversight across manufacturing instructions, ensuring compliant manufacturing processes, Master Batch Records, validations, change controls, risk assessments, and production documentation.
• Lead regulatory inspections, internal audits, supplier audits, and partner audits, ensuring effective preparation, execution, remediation, and continuous compliance improvement.
• Direct global deviation, investigation, and CAPA activities, ensuring robust root cause analysis, risk‑based decision making, and sustainable corrective actions.
• Establish and strengthen internal and external quality standards, proactively translating evolving GMP, GDP, and ISO requirements into practical and effective business processes.
• Oversee manufacturing network performance, including CDMO management, manufacturer qualification, manufacturing transfers, technology transfers, process improvements, and integration of new products and manufacturing partners.
• Foster a culture of quality, operational excellence, continuous improvement, and safety through leadership, coaching, training, and effective cross‑functional collaboration across the business.

What You Bring

• Degree in Pharmacy, Life Sciences, Chemistry or a related scientific discipline.
• Qualified Person (QP) certification strongly preferred; candidates with Deputy QP experience and the potential to assume QP responsibilities are highly desirable.
• Significant leadership experience within pharmaceutical manufacturing, quality assurance, and regulated production environments.
• Strong manufacturing background with a practical understanding of production operations and external manufacturing networks.
• Demonstrated experience managing CDMOs, quality agreements, complex supplier relationships, and manufacturing transfers.
• Fluent German and English with the ability to effectively lead stakeholders across Switzerland, Germany, and international markets.
• Strong international leader with proven success navigating multicultural, global environments.
• Hands‑on, pragmatic, and action‑oriented; driving results through collaboration and accountability.
• Willingness to travel up to 50% across multiple sites in Europe.

Why Join Medinova

• A challenging role in an international context, open and direct communication and flat hierarchies
• Attractive fringe benefits (financial contribution to sports courses and public transport, cultural activities, meal allowance)
• Above average pension fund and private accident insurance coverage
• Flexible working time model with flexible working hours and home office arrangement
• 25‑30 vacation days
• The DKSH Fantree Academy, our in‑house training and development centre, offers various programs to support the development of our employees

Medinova AG

At home in Zurich, represented in over 65 countries around the world.

Medinova AG was founded in Zurich over 75 years ago with the aim of producing pharmaceutical specialties from chemical raw materials. Today, the focus is on the marketing and distribution of prescription drugs and over‑the‑counter products in the areas of gynecology and dermatology. Our Swiss quality standard is valued worldwide. As a medium‑size Swiss company, we will continue to create jobs and rely on Switzerland as a location in the future. Medinova AG is part of the network of our parent company, DKSH, the leading company in the field of market expansion services with a focus on Asia.

https://www.medinova.ch/en/about-us/