Global Site Quality Leader & Compliance Strategy

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

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.