Sr. Director - Site Quality Lead

• 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.

• 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.

• →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.

• 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!

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