Regulatory affairs specialist Jobs in Nordholz

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. 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, 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. This role is a core member of the Cuxhaven site leadership team who collectively steer the business mission of the site.

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. As a member of, and collaborating with, the Site Leadership Team, drive continuous improvement through development and execution of a robust Quality Plan.
• Provides 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. Ensure robust root cause investigations are conducted with appropriate CAPAs to resolve issues that may impact the quality and / or regulatory compliance of manufactured products.
• Serves as the leader for regulatory inspections at the site. Ensures compliance with all regulatory requirements relating to product quality and right to operate by implementation of relevant regulatory requirements, as well as education and training of the workforce.
• Responsible for final approval at the site for the following : testing, inspection and release of packaging components, raw materials, labeling, and finished products; product and process validation; quality documentation; and execution of release of products, recalls, market withdrawals.
• Develop the organization to improve technical depth and capabilities related to Biotech products manufacturing. This includes identifying individuals with technical and / or leadership potential for succession planning, or recruiting talent as needed. Will champion the efforts of 5 direct reports and lead an overall Quality organization of roughly 45 personnel.

What You Need to Succeed (minimum qualifications) :

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

Additional Information :

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