Sr. Director, Quality (Project Management)
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, Site 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 Elwood, KS 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:
- Strategic Quality Leadership & Continuous Improvement: Provides strategic leadership and oversight for Quality Assurance, Compliance, and Quality Control testing, driving continuous improvement through a robust Quality Plan and collaboration with the Site Leadership Team. This includes final approval for testing, inspection, and release of materials (packaging components, raw materials, labeling) and finished products, as well as product/process validation and quality documentation. Oversees product release, recalls, and market withdrawals.
- Biotech Manufacturing Expertise Development: Develops and enhances the organization's technical capabilities in Biotech product manufacturing, including talent identification, succession planning, recruitment, and leadership of a Quality organization of approximately 20 personnel (including 7 direct reports).
- GxP Training & Education: Leads strategic planning, direction, and execution of all GxP training activities at the site, ensuring compliance with regulatory requirements and educating the workforce on relevant quality and compliance topics.
- Quality Systems Implementation & Issue Resolution: Leads the implementation of quality policies, systems, and procedures to assure product purity, efficacy, safety, and potency. Ensures robust root cause investigations and corrective actions (CAPAs) for quality and compliance issues impacting manufactured products.
- Regulatory Compliance & Business Partnership: Serves as the site leader for regulatory inspections, ensuring compliance with all requirements for product quality and right to operate. Partners with various internal and external entities (Sites under Establishment 196 licensure, Operations, Technical Services, Manufacturing Science, Marketing, R&D, Regulatory Affairs) on quality and compliance matters related to current products, product launches, and worldwide production/distribution approvals.
What You Need to Succeed (minimum qualifications):
- Education: Bachelor's degree in Chemistry, Bio/Pharmaceutical Technology, Microbiology, or a related discipline.
- Experience: 10+ years' experience in pharmaceutical and/or vaccine/Biotech production. 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).
- Previous experience building a Quality Culture and developing high functioning teams
What will give you a competitive edge (preferred qualifications):
- Advanced degree highly preferred
- Monoclonal antibodies (mAbs) manufacturing experience is strongly 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:
- Location: Elwood, Kansas: 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
