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 Winslow, ME 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. 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 6 direct reports and lead an overall Quality organization of roughly 40 personnel.
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 cGMP regulatory requirements for Biotech products, including direct experience with external audits (USDA, FDA, EMEA).
What will give you a competitive edge (preferred qualifications):
- Advanced degree highly preferred
- Previous Poultry and/or Egg-based vaccine manufacturing experience
- 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:
- Winslow, ME: On-Site Work Environment – Excellent relocation package available!
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
Top Skills
What We Do
At Elanco, we work to improve the health of animals through innovative products and services for pets and farm animals around the world. As a global animal health company, we provide solutions that empower our customers to advance a vision of Food and Companionship Enriching Life. Since 1954, Elanco has committed to empowering veterinarians, farmers, and all those who care for animals with the tools they need to help animals live healthy lives.
Healthier animals are the key to making our lives better - This is the fundamental belief uniting all global Elanco employees. That’s why we are committed to the idea that our business can be a unique force for good for all in society.
Through our Elanco Healthy Purpose™ framework of Environmental, Social and Governance (ESG) commitments, we focus on delivering sustainable solutions to advance the well-being of animals, people and the planet. This program also enables our employees around the world to take paid time off to make an impact as a volunteer, offering their time or talent to give back to our customers, causes and communities. #ElancoHealthyPurpose #WeAreElanco
