The Site Quality Lead role is accountable for product quality and the site’s regulatory compliance standing – maintaining a state of Inspection Readiness. The Role ensures the QC function meets all regulatory compliance requirements and GMPs.
The Site Quality Lead champions the Quality Culture and takes proactive steps to prevent any decay in the state of quality and compliance at the site.
The position reports to the Platform Quality Leader.
The Site Quality Lead is a member of the Site Leadership Team and participates in setting the strategic direction of the quality unit and the site as well as managing day-to-day quality operations. The position also co-chairs the site Quality Council (with the Site Lead) to drive continuous improvement and compliance objectives as well as prioritizing quality improvement initiatives.
The role has ownership of the Site Risk Assessment Process – leading the Site Leadership through the process on a predetermined cadence.
The Quality Lead uses data and metrics to drive continuous improvement in site quality systems as well as Product Quality. Additionally – the role is responsible for creating and executing the Site Quality Roadmap.
- Establishing / Reinforcing the Quality Culture on the Site; Contributing member of the Site Leadership Team
- Implementation of Quality Standards
- Maintain Site Inspection Readiness. Promote Compliance Audit findings/remediation.
- Ensure that products are manufactured in compliance with Registration File (and appropriate Reg Bodies)
- Ensure Product Release is done within Regulatory Standards and pertinent Registration Files.
- Ensuring QC Testing meets Regulatory Compliance and GMPs.
- Proactive Ownership of the Site Risk Assessment process.
- Oversee the development and implementation of the Quality Plan / Quality Road Map
- Share Leadership of Site Quality Councils and Metrics
- Develop metrics to deliver product and process improvement.
- Maintain the Supplier Quality program and vendor certification.
- Ensure the Validation Master Plan is compliant and up to date. (Validation strategy and site compliance)
- Create and be accountable for the Site QA/QC Budget.
- Champion Leadership Development for the Site Quality Staff.
- Overall Site Product Portfolio Quality Stewardship owner and accountability.
Staff and Leadership Responsibilities
- Leadership Development / Coaching of Staff; Creation of Learning Organization
- Stewardship of the Quality Culture within the QA Function as well as the Site.
- Ensure Training and Development plans are in place for all QA associates.
- Development of Site QA operations budget and resource planning for roll up to the Site Quality Budget.
- Support the development of Quality goals and targets as part of the organization’s strategic plan.
- Direct Supervision: 5 staff reports
Total Site Quality Organization: 66 head count
Quality Unit also utilizes approximately 1 temporary contract worker (contingent employees
Education and Experience
- Science or Engineering BS / MS / PhD
- Demonstrated significant leadership experience in a Quality Role in Animal Health / Human Health manufacturing
- Operations or Quality Experience in Biological Manufacturing, especially cell-associated, live and killed virus and bacteria-based vaccines.
- Experience with USDA, VMD and EU agencies having oversight of veterinary immunologicals.
- Fluent with Six Sigma and/or Lean Manufacturing
Technical Skills Requirements
- Does well in a Change Management environment, Acts as a Change Agent
- Problem solver, root cause analysis methodology
- Process oriented mindset; data and continuous improvement orientation
- Able to work well in complex environment
- Position located in Charles City, IA
- Minimal off-site travel
- Occasional non-core hour work anticipated