Quality Control Manager
Haleon View all jobs
- Dungarvan, Co Waterford
- Permanent
- Full-time
- Lead site Quality Control operations in compliance with GMP, regulatory, and Haleon Quality Management System requirements.
- Act as Management Representative for EU Medical Devices within the QC function.
- Ensure readiness for, and lead participation in, external regulatory inspections and internal audits.
- Provide quality leadership during deviations, investigations, and compliance-related incidents.
- Champion continuous improvement and effective escalation, decision-making, and risk management.
- Oversee analytical and microbiological testing of raw materials, intermediates, APIs, final products, and stability samples.
- Ensure effective environmental and utilities monitoring and microbiological assurance.
- Maintain oversight of laboratory instrumentation, including qualification, calibration, and maintenance.
- Ensure compliant sample management, including retains and stability programs.
- Authorise release for use of materials in line with site procedures.
- Act as site Aseptic Expert, providing leadership on environmental monitoring, microbiological control, and aseptic assurance.
- Support aseptic-related projects, investigations, shutdown activities, and liaison with global aseptic networks.
- Lead QC supplier management activities, including compliance of specifications, COAs/COCs, and resolution of quality issues.
- Represent QC at supplier forums and escalation meetings as required.
- For applicable products/markets, ensure compliance with Halal Product Assurance System (HPAS) requirements and participate in the Halal Management Team.
- Lead, develop, coach, and motivate the Quality Control team.
- Foster strong cross-functional collaboration across site functions.
- Support recruitment and succession planning aligned with long-term site quality strategy.
- Contribute quality input to site leadership decisions, strategy, and change initiatives.
- Manage QC budgets (Opex/Capex) and support operational excellence initiatives.
- Degree in Chemistry or a related science discipline.
- Preferred: Third-level science degree (postgraduate advantageous) and Certified Qualified Person (QP).
- 3–5 years’ experience in a Quality Management or Quality Control leadership role within the pharmaceutical or healthcare industry.
- Proven ability to lead and develop teams of highly skilled technical professionals.
- Demonstrated experience driving continuous improvement and adapting quality systems to changing business and regulatory demands.
- Strong understanding of Quality Control operations, manufacturing processes, and site-wide Quality Management Systems.
- In-depth knowledge of global regulatory and compliance requirements for medicinal products and medical devices, including:
- EU/UK GMP, EU MDR, ISO 13485
- US cGMP (21 CFR 210/211, 820)
- Japanese and other international regulatory frameworks
- Membership of relevant professional bodies (e.g. C.Chem, MRSC) desirable.
- Strong leadership, decision-making, and stakeholder engagement skills.
- Ability to provide effective quality input into senior management and business decisions.