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

Stellenbeschreibung

As the Site Quality Leader, you will own the Quality Assurance and Quality Control functions for the Kiel manufacturing site, leading an organization of approximately 130 personnel. You will provide strategic, regulatory, and technical leadership to ensure the sustainable performance and compliance of this high impact site within the Elanco network.

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.

Additional Information:
Location: Kiel Manufacturing Site, Germany