Sr. Director - Site Quality Lead

Elanco; Fort Dodge (IA); On-site; USD 180,000 - 240,000; Full time

Job summary

Elanco in Fort Dodge, IA, seeks a Sr. Director, Site Quality Head to lead quality and compliance across vaccine manufacturing, QC, and contract manufacturers, supporting global product distribution. The role drives global strategies, regulatory interactions, and site-level quality leadership.

Ideal candidates bring extensive pharma/vaccine manufacturing experience, senior leadership, and a proven track record in budget management, regulatory inspections, and cross-functional collaboration.

Qualifications

• 10+ years’ experience in a commercial pharmaceutical and/or vaccine manufacturing environment and 5+ years’ leadership experience in directing employees, projects and business/functions
• Demonstrated competency developing partnerships with regulatory authorities to amiably resolve quality & compliance issues
• Sound business acumen to include previous budget process design and management
• Advanced degree (preferred)

Responsibilities

• Strategic Leadership: Establish global quality and compliance strategies for biological vaccines, providing site-level leadership to drive operational improvements and define validation policies.
• Regulatory Compliance & Liaison: Serve as the primary liaison between Corporate QA and Regulatory Affairs, managing regulatory inspections and ensuring technical compliance across US and global markets.
• QA/QC Operational Oversight: Direct all biological Quality Assurance and Quality Control functions, including budget management, vendor certifications, and the testing and release of components and finished products.
• Product Safety & Surveillance: Lead the global investigation of all product quality complaints and adverse events to ensure continued product safety and regulatory adherence.
• Standards & Training: Maintain rigorous Elanco quality standards and direct regulatory training programs for operations teams to ensure organizational compliance and excellence.

Skills

Strategic leadership

Regulatory liaison

QA/QC leadership

Budget management

Cross-functional collaboration

Education

Bachelor's degree in biology, chemistry, biochemistry, virology or science-related field

Job description

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. At Elanco, we are driven by our vision of Food and Companionship Enriching Life and our purpose – all to Go Beyond for Animals, Customers, Society and Our People.

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: Sr. Director, Site Quality Head

Provide strategic leadership and oversight for quality and compliance initiatives across Fort Dodge Vaccine Manufacturing, Quality Control, and Site Contract Manufacturers to support the global distribution of the product portfolio.

Your Responsibilities:

• Strategic Leadership:Establish global quality and compliance strategies for biological vaccines, providing site-level leadership to drive operational improvements and define validation policies.
• Regulatory Compliance & Liaison:Serve as the primary liaison between Corporate QA and Regulatory Affairs, managing regulatory inspections and ensuring technical compliance across US and global markets.
• QA/QC Operational Oversight:Direct all biological Quality Assurance and Quality Control functions, including budget management, vendor certifications, and the testing and release of components and finished products.
• Product Safety & Surveillance:Lead the global investigation of all product quality complaints and adverse events to ensure continued product safety and regulatory adherence.
• Standards & Training:Maintain rigorous Elanco quality standards and direct regulatory training programs for operations teams to ensure organizational compliance and excellence.

What You Need to Succeed (minimum qualifications):

• Education: Bachelor’s degree in biology, chemistry, biochemistry, virology or science-related field.
• 10+ years’ experience in a commercial pharmaceutical and/or vaccine manufacturing environment and 5+ years’ leadership experience in directing employees, projects and business/functions
• Demonstrated competency developing partnerships with regulatory authorities to amiably resolve quality & compliance issues.
• Sound business acumen to include previous budget process design and management.

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

• Advanced degree

• Understanding of USDA, FDA, 9CFR,Australian, Canadian and EU GMP regulatory requirements.
• Versatility in conflict resolution, problem solving and working with cross functional teams. Sound business acumen and strategic mindset required.
• Ability to network and build strong, collaborative relationships across functions / geographies.
• Strong mentoring and coaching skills.

Additional Information:

• Travel:10%
• Onsite Location: Ft. Dodge, IA Manufacturing Facility

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

Elanco may use automated tools, including AI, to support parts of our recruitment process, such as reviewing applications against job‑related criteria and/or transferrable skills. These tools help ensure a consistent, structured evaluation, but they do not make hiring decisions. All decisions involve a human reviewer. For more information on how we handle personal data, please see our Elanco Workforce Privacy Notice.