Global Site Quality Leader — Vaccines & Compliance

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

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.