Director, Quality Management Systems (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: Director, Quality Management Systems
Responsible for the design, implementation, continuous improvement, and oversight of robust Quality Management Systems (QMS) at the Elanco Fort Dodge site to support a risk-based quality culture in alignment with Elanco and industry standards. Monitors the health of the Elanco QMS at the Fort Dodge site and identifies cross-functional areas of opportunity or risk for action and reports to the appropriate quality governance.
Your Responsibilities:
- Leads Quality Management Systems (QMS): Implements, maintains, and improves QMS processes, ensuring compliance with regulations and Elanco standards. Provides technical guidance and training to the QMS team. Oversees budgets, authors the Site Quality Plan, and drives continuous improvement initiatives.
- Manage Audits and Inspections: Prepares for and manages regulatory inspections and corporate audits. Ensures inspection readiness, reviews QMS records, and drives timely completion of corrective actions.
- Provides Quality Governance: Develops and implements governance processes (e.g., Quality Lead Team, Deviation Review Board). Identifies and analyzes quality risks, reporting the overall state of QMS control to senior leadership.
- Oversees Training and Development: Develops and executes training programs for the Elanco QMS. Ensures training program effectiveness within the QMS department. Identifies professional development opportunities for self and team.
- Leads Investigations and CAPA: Reviews and approvals of manufacturing and Quality department investigations, ensuring compliance, root cause identification, and effective corrective and preventative actions (CAPA).
What You Need to Succeed (minimum qualifications):
- Education: Bachelor's degree in science-related discipline.
- Experience: 10+ years' experience in a regulated pharmaceutical/vaccine manufacturing environment. 5+ years of experience in people management including direct & indirect reports.
- Thorough knowledge of cGMP/GLP regulatory requirements for Biotech products, including direct experience with external audits (USDA, FDA, EMEA).
- Previous experience in department oversight (organizational, budgeting, strategy).
What will give you a competitive edge (preferred qualifications):
- Advanced degree highly preferred
- Demonstrated proficiency in lean/5S/six sigma methodologies
- 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: Fort Dodge, Iowa: 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
