About this role
Job title: Site Quality Lead
About the Role The Site Quality Lead is accountable for product quality and regulatory compliance at the Charles City site, maintaining inspection readiness and ensuring a continuous supply of high-quality products. The role leads quality operations, champions the quality culture, and collaborates with the Bio/BioPharma Platform Quality Leader and Site Leadership Team; co-chairs the Site Quality Council to drive continuous improvement and compliance objectives.
What You'll Do
- Lead Site Quality Management System ownership and ensure compliance with regulatory standards, including cGMPs, and maintain inspection readiness with USDA, VMD, and European agencies.
- Oversee QC testing, development and implementation of standards, methods and procedures for inspecting, testing, and analyzing raw materials and finished products; partner with regulatory teams to ensure regulatory compliance; drive the Site Risk Assessment and supplier quality programs.
- Create and execute the Site Quality Road Map; develop metrics and drive data-driven continuous improvement; steward the Site Quality Management System and promote quality culture across the site.
- Act as site point of contact for inspections and remediation of audit findings; collaborate with other site leaders and functions; manage budget and resource planning; coach staff and develop a learning organization.
What We're Looking For
- BS/MS/PhD in Biological, Chemistry or Engineering; significant leadership experience in a Quality role within Pharmaceutical, Vaccine, Animal Health or Human Health manufacturing.
- Operations or Quality Manufacturing experience; USDA and European Agencies regulated work experience desired.
- Fluent with Six Sigma and/or Lean Manufacturing; excellent communication and collaboration skills; strong problem solving, root cause analysis, and data-driven decision making; change management capabilities.
Nice to Have
- USDA and European regulatory experience is desired.
Compensation & Benefits
- Salary range and benefits not disclosed in the posting.