Senior Director - Site Quality (m/f/d) (Qualitätsmanager/in)

Your Responsibilities:

• Oversee all aspects of Quality Management to ensure regulatory standards are met, regularly assessed, and reported to global leadership. •
• Drive readiness for Health Authority inspections (PAI, directed, etc.) and ensure all GMP follow up actions from audits are effectively actioned. •
• Manage the organizational Quality budget and deploy operational excellence strategies to drive lab and site-wide productivity. •
• Recruit and develop global talent to build a high-performance culture and a robust succession pipeline for critical Quality roles. •
• Partner cross-functionally with Manufacturing, Supply Chain, and R&D to ensure quality objectives are achieved during product transfers and new launches.

What You Need to Succeed (minimum qualifications):

• Education: Bachelor’s Degree in a scientific field. •
• Experience: A minimum of 10 years of management or project management experience in the pharmaceutical industry (DP/API), including at least 5 years specifically in Quality Assurance. •
• Comprehensive knowledge of global cGMP requirements and a proven track record in inspection management with authorities such as the FDA and EMA. •
• Fluency in English and German.

What will give you a competitive edge (preferred qualifications):

• Technical understanding of DP/API manufacturing and testing processes. •
• Demonstrated ability to lead through transformation and drive digital roadmaps. •
• Strong competency in Quality Risk Management techniques and problem-solving in ambiguous environments. •
• Experience in both site-level and network-level Quality leadership. •
• Experience with Tablets or Liquids is preferred.

Anforderungen an den Bewerber:

• Zwingend erforderlich: Qualitätsmanagement,
• Qualitätsprüfung,
• Qualitätssicherung

Additional Information:

Location: Kiel Manufacturing Site, Germany Ergänzende Informationen: