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

Elanco Tiergesundheit AG; Kiel; Vor Ort; EUR 150.000 - 190.000; Vollzeit

Zusammenfassung

Elanco Tiergesundheit AG in Kiel, Germany, is seeking a Senior Director – Head of Quality to lead the Site Quality function. You will own QA and QC, provide regulatory and technical leadership, and manage ~130 personnel at the Kiel manufacturing site.

You will ensure GMP compliance, readiness for health authority inspections, budget management, talent development, and cross-functional partnerships with Manufacturing, Supply Chain and R&D to support product transfers and launches.

Qualifikationen

• Education: Bachelor’s Degree in a scientific field.
• Minimum 10 years of management or project management experience in the pharmaceutical industry (DP/API), with at least 5 years in Quality Assurance.
• Fluency in English and German; knowledge of global cGMP and health authority inspections (FDA/EMA).

Aufgaben

• 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 and ensure GMP follow-up actions are effectively actioned.
• Manage the organizational Quality budget and deploy operational excellence strategies to drive productivity.
• Recruit and develop global talent to build high-performance culture and succession pipelines for key Q roles.
• Partner with Manufacturing, Supply Chain, and R&D to ensure quality objectives during transfers and launches.

Kenntnisse

Quality Management

Regulatory knowledge

Leadership

English & German fluency

Budget management

Project management

Ausbildung

Bachelor’s Degree in a scientific field

Jobbeschreibung

At Elanco (NYSE: ELAN) – it all starts with animals!As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. At Elanco, we are driven by our vision of Food and Companionship Enriching Life and our purpose – all to Go Beyond for Animals, Customers, Society and Our People.At Elanco, we pride ourselves on fostering a diverse and inclusive work environment. We believe that diversity is the driving force behind innovation, creativity, and overall business success. Here, you’ll be part of a company that values and champions new ways of thinking, work with dynamic individuals, and acquire new skills and experiences that will propel your career to new heights.Making animals’ lives better makes life better – join our team today!Your Role: Senior Director – Head of Quality (m/f/d)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, GermanyElanco is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected statusElanco may use automated tools, including AI, to support parts of our recruitment process, such as reviewing applications against job‑related criteria and/or transferrable skills. These tools help ensure a consistent, structured evaluation, but they do not make hiring decisions. All decisions involve a human reviewer. For more information on how we handle personal data, please see our Elanco Workforce Privacy Notice.