Sr. Director - Site Quality Lead

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

Job summary

Elanco in Fort Dodge, IA is seeking a Sr. Director, Site Quality Head to lead global quality strategies for biological vaccines supporting the company’s product portfolio.

The role provides site-level leadership across Vaccine Manufacturing, Quality Control and Site Contract Manufacturers, driving regulatory readiness, QA/QC oversight, and continuous improvement while partnering with regulatory authorities worldwide.

Qualifications

• Bachelor’s degree in biology, chemistry, biochemistry, virology or science-related field.
• 10+ years in a commercial pharmaceutical/vaccine manufacturing environment with 5+ years of leadership.
• Proven ability to partner with regulatory authorities to resolve quality & compliance issues.
• Sound business acumen including budget design and management.

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

Leadership

Regulatory liaison

Budget management

Quality assurance

Cross-functional

Education

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

Job description

Sr. Director - Site Quality Lead (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. 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

Don't meet every single requirement? Studies have shown underrecognized groups are less likely to apply to jobs unless they meet every single qualification. At Elanco we are dedicated to building a diverse and inclusive work environment. If you think you might be a good fit for a role but don't necessarily meet every requirement, we encourage you to apply. You may be the right candidate for this role or other roles!

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.