Global Site Quality Director – Vaccines & Compliance

Elanco Tiergesundheit AG

Fort Dodge (IA)

On-site

USD 180,000 - 240,000

Full time

14 days+

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Job summary

Elanco seeks a Sr. Director, Site Quality Head for the Fort Dodge Vaccine Manufacturing site to provide strategic leadership and oversight for quality and compliance across manufacturing, QA/QC, and site contract manufacturers.

You will drive regulatory liaison, manage inspections, budgets, vendor certifications, and the investigation of product quality complaints to ensure safety and regulatory adherence. Travel about 10%; onsite Ft. Dodge, IA.

Qualifications

Bachelor’s degree in biology, chemistry, biochemistry, virology or science-related field.
10+ years in a commercial pharmaceutical and/or vaccine manufacturing environment and 5+ years’ leadership experience directing employees, projects, and functions.
Experience partnering with regulatory authorities to resolve quality & compliance issues.

Responsibilities

Establish global quality and compliance strategies for biological vaccines and lead site-level quality initiatives.
Serve as liaison between Corporate QA and Regulatory Affairs and manage regulatory inspections.
Direct all biological QA and QC functions, including budget management and testing and release of components and finished products.
Lead global investigations of product quality complaints and adverse events to ensure safety and regulatory adherence.
Maintain Elanco quality standards and direct regulatory training programs for operations teams.