Senior Director - Quality Site Lead
As a leading global animal health company, Elanco delivers innovative products and services to improve the health of pets and farm animals around the world because we believe making animals' lives better, makes life better. Since 1954, we have provided solutions that support veterinarians, farmers and pet owners to advance our vision of Food and Companionship Enriching Life. Elanco's promise to employees: Together, we foster an inclusive culture where everyone can make a difference, encouraging ownership, growth and well-being.
Elanco is a Global Leader in pet and farm animal health products. With almost $5 Billion in revenue, our 9000 employees manufacture and market over 200 brands in 90 countries. The Elanco Fort Dodge, IA site manufactures multi-species vaccines for the global market which accept USDA registrations. We produce over 120 different references of inactivated and modified live vaccine products. Our processes include fermentation and cell-based production of viral and bacterial antigens, inactivation, downstream processing, formulation, liquid filling, and lyophilization of finished products. The site sits on ~335 acres, with approximately 420 employees, and is the only Elanco Biotech site to have Manufacturing & Quality (M&Q), Research & Development (R&D), and Animal Care in one location.
Though the region may be considered rural by most standards, the town has a community college and a large university 1 hour from the plant (Ames, IA). Ames is a short drive to a major metropolitan area—30 minutes to Des Moines (state capital). For the nature lovers, you can visit hundreds of thousands of acres of public lands for hiking, fishing, camping, hunting, four-wheeling. Come lead a smart, energetic team, and be an impactful part of a rapidly growing company with a variety of career opportunities inside and outside of Iowa.
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 Fort Dodge 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 Fort Dodge site leadership team who collectively steer the business mission of the site.
Functions, Duties, Tasks:
- 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.
- 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 80 personnel.
- Responsible for Strategic planning, direction, and leadership for all GxP training activities at the site.
- 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.
- Provides business partnership to various departments and entities within the broader network such as but not limited to: Sites operating under Establishment 196 licensure, Operations, Technical Services and Manufacturing Science, Marketing, Research and Product Development, Regulatory Affairs; for quality & compliance topics relating to current products, product launch, and for getting the facilities registered /approved for worldwide production/distribution.
- 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.
- Bachelor’s degree in biochemistry, chemistry, virology, biology, or science related field; Advanced degree highly preferred
- 10+ years of experience in pharmaceutical and/or vaccine/Biotech production.
- 5+ years of experience in people management including direct & indirect reports.
- Thorough knowledge of 9CFR (USDA) regulatory requirements for Biotech products, including direct experience with external audits.
- Ability to set up partnerships with regulatory authorities and Elanco relevant Functions to resolve quality & compliance issues.
- Versatility in conflict resolution, problem solving and working with cross functional teams.
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
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