Director, Global QA & Production Excellence

Medinova AG; Zürich; Vor Ort; CHF 200.000 - 270.000; Vollzeit

Benefits dieser Stelle

Fringe benefits

Flexible hours

Vacation days

Zusammenfassung

Medinova AG in Zürich requires a Director of Quality Assurance & Production Management to lead global quality and manufacturing strategies. Based at our Zurich headquarters, this senior role influences compliance, operational excellence and growth with hands-on oversight and strategic leadership across international operations.

The ideal candidate brings a strong pharmaceutical quality and manufacturing background, with QP or Deputy QP experience, fluency in German and English, and willingness

Qualifikationen

• Degree in Pharmacy, Life Sciences, Chemistry or related scientific discipline.
• Qualified Person (QP) certification strongly preferred; Deputy QP experience desirable.
• Significant leadership experience in pharmaceutical manufacturing, quality assurance, and regulated production environments.
• Strong manufacturing background with 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 ability to lead stakeholders across Switzerland, Germany, and international markets.
• Willingness to travel up to 50% across multiple sites in Europe.

Aufgaben

• Lead the Quality Assurance & Production Management organization, including leadership, resource planning, budget accountability, KPI management and strategic initiatives.
• Define and execute global quality and compliance strategy, ensuring GMP, GDP, ISO13485 and regulatory readiness.
• Own and continually improve the global Quality Management System (QMS) and key quality processes such as document control, change control, deviations, CAPAs, supplier qualification, complaints, risk management and PQRs.
• Oversee manufacturing instructions, ensuring compliant processes, Master Batch Records, validations, change controls, and production documentation.
• Lead regulatory inspections, internal and supplier audits, ensuring preparation, execution, remediation and continuous compliance improvement.
• Direct deviation, investigation and CAPA activities with robust root causes analysis and risk-based decisions.
• Translate GMP, GDP, ISO requirements into practical business processes and standards.
• Oversee manufacturing network performance, CDMO management, technology transfers and new product integrations.
• Foster a culture of quality, operational excellence, and safety through leadership and cross-functional collaboration.

Kenntnisse

Leadership

GMP/GDP/ISO13485

QMS Management

Regulatory Inspections

CDMO Management

Cross-functional Collaboration

German & English

Ausbildung

Degree in Pharmacy, Life Sciences, Chemistry or related

Jobbeschreibung

Medinova AG in Zürich requires a Director of Quality Assurance & Production Management to lead global quality and manufacturing strategies. Based at our Zurich headquarters, this senior role influences compliance, operational excellence and growth with hands-on oversight and strategic leadership across international operations.

The ideal candidate brings a strong pharmaceutical quality and manufacturing background, with QP or Deputy QP experience, fluency in German and English, and willingness