Senior Quality Director
Viatris
Pharmaceutical Industry
Dublin, Tipperary - Irland
Manager / Team Leader
Experteer Overview
In this role you will lead the MDR Quality Operations to ensure GxP compliance across the site and external network, applying global quality standards to deliver high-quality products. You will oversee QA, QC, and quality compliance for manufacturing, inhaler assembly, packaging, testing, and release, championing a strong culture of quality. You will develop and maintain the Quality Management System and Compliance Strategy, coordinate with health authorities, and drive continuous improvement. Your leadership will ensure audit readiness and effective CAPA processes, enabling safe, compliant product release. This is an opportunity to shape quality leadership in a global pharma setting with a
Pay / Benefits
- Excellent career progression opportunities
- Work-life balance initiatives
- Bonus scheme
- Health insurance
- Pension
- Diversity & Inclusion at Viatris
Responsibilites
- Lead MDR Quality Operations (Quality Compliance, QA, QC) ensuring training, SOPs, EU/US FDA, and GMP compliance
- Apply Global Quality Standards across site and external network for GxP compliance and continuous improvement
- Provide quality oversight across supply, manufacturing, inhaler assembly, packaging, testing, and release
- Develop and maintain the Quality Management System and Compliance Strategy aligned with regulatory expectations
- Ensure timely communication of Quality issues with Senior Management and external organizations
- Ensure manufacturing, packaging, testing, and release follow written procedures and authorizations
- Lead investigations of deviations/abnormal events and implement CAPA actions
- Recruit, train and develop personnel for Quality operations including QP release per EU directives
- Lead interactions with HPRA, FDA and other health authorities
- Develop and monitor metrics for Quality Unit performance, QC testing, and Product Release
- Review and critique regulatory submission documents and streamline systems/procedures
- Ensure vendor management program is efficient and effective
- Coordinate budget and headcount planning for the Quality Unit
Key requirements
- Experience leading Audits and direct interaction with Health Authorities
- QP release authority with direct experience releasing batches
- Third party release and quality oversight experience (desirable)
- Experience with Lean manufacturing/labs
- Strong leadership and team management skills
- Experience with Medical Device Regulations and combination products (preferred)
Description
In this role you will lead the MDR Quality Operations to ensure GxP compliance across the site and external network, applying global quality…
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