Site Quality Lead (IE_Tall_SQL) Dublin South, Republic of Ireland
Role Summary
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 that 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. Additonally – the role is responsible for creating and executing the Site Quality Roadmap.
Role Responsibilities
- 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.
- Insure that products are manufactured in compliance with Registration File (and appropriate Reg Bodies)
- Insure Product Release is done within Regulatory Standards and pertinent Registration Files.
- Insuring 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.
- Insure 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.
- Insure 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 organisation’s strategic plan.
Organisational Relationships
- Quality Platform Lead
- Global QSS
- Manufacturing Site Leadership
- Corporate Quality Auditing
- Site Enabling Functions (ie: Engineering; GMT; Finance etc)
- Operational Excellence
- VMRA and VMRD
Candidate Requirements
Education & 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 Aseptic Manufacturing
- HRPA, FDA, and EU regulated work experiences desired
- Fluent with Six Sigma and/or Lean Manufacturing
Technical Skills
- 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