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

Senior Director, Site Quality (m/f/d) bei Lohmann Animal Health

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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. We're driven by our vision of ‘Food and Companionship Enriching Life' and our approach to sustainability – the Elanco Healthy Purpose – to advance the health of animals, people, the planet and our enterprise.
At Elanco, we pride ourselves on fostering a diverse and inclusive work environment. Making animals' lives better makes life better – join our team today!

Your Role: Senior Director, Quality

Reporting to the Biotech Global Quality Leader, with dotted-line reporting to the Site Head, this role is responsible for providing technical, regulatory/compliance, and strategic leadership for the Quality function at the Cuxhaven, GER site. This leader is accountable for all Product Quality, Compliance and Quality System activities as well as for development, launch and commercialization of new products in collaboration with Elanco R&D and other relevant functions.

Your Responsibilities

• Provide strategic leadership and oversight for Quality Assurance and Compliance initiatives, as well as Quality Control testing facilities, for global product launch, manufacturing, and distribution.
• Provide leadership and direction to the Operations Unit for implementing quality policies, strategic plans, systems and procedures that will assure purity, efficacy, safety and potency of all products manufactured or tested at the facility.
• Serve as the leader for regulatory inspections at the site.
• Responsible for final approval at the site for testing, inspection and release of packaging components, raw materials, labeling, and finished products.
• Develop the organization to improve technical depth and capabilities related to Biotech products manufacturing.

What You Need To Succeed (minimum Qualifications)

• Education: Bachelor's degree in biochemistry, chemistry, virology, biology, or other science related field.
• Required Experience: 10+ years of experience in pharmaceutical and/or vaccine/Biotech production with increasing responsibilities in Quality Assurance.
• 5+ years of experience in people management including direct & indirect reports.
• Thorough knowledge of EU-GMP regulatory requirements for Biotech products.
• English and German language fluency.

What Will Give You a Competitive Edge (preferred Qualifications)

• Advanced degree highly preferred.
• Ability to set up partnerships with regulatory authorities to resolve quality & compliance issues.
• Versatility in conflict resolution, problem solving and working with cross functional teams.
• Sound business acumen and strategic mindset.

Additional Information

• Ability to travel nationally & internationally as needed.

Elanco 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 status.

Please be advised that a valid work permit for Germany is required for non-EU citizens. Unfortunately, applications without a valid work permit and sufficient German language skills may not be considered.