Quality Manager
Sligo
My client is seeking an experienced Quality Manager to lead the QA team. This role ensures that all products manufactured on-site meet the highest standards of GMP compliance, regulatory requirements, and customer expectations. The successful candidate will oversee QA operations, team performance, audits, and compliance activities, while partnering closely with cross-functional teams to maintain and continuously improve product quality.
Key Responsibilities
- Ensure all products meet the requirements of end users, regulatory authorities, and internal quality standards.
- Lead and manage the Quality Assurance team, providing guidance, mentorship, and support on quality and compliance matters.
- Act as the site contact for regulatory and customer audits/inspections (FDA, HPRA, etc.) and prepare teams for successful outcomes.
- Oversee the implementation and follow-up of CAPAs (Corrective and Preventive Actions).
- Collaborate cross-functionally to resolve quality issues, enhance processes, and ensure ongoing cGMP compliance.
- Promote departmental goals by attracting, developing, and retaining skilled QA professionals.
- Support talent management and professional development within the QA team.
- Develop, review, and approve QA documentation related to general quality activities.
- Provide oversight of batch record reviews, deviation investigations, change controls, and product release decisions.
- Monitor and report on key quality metrics and trends.
- Communicate effectively with internal stakeholders, regulatory bodies, and customer quality representatives.
- Serve as a designee for the Biologics Quality Director as required.
Qualifications & Experience
- Bachelor's degree in Science, Quality, Engineering, or a related field (Master's preferred).
- Minimum of 8 years' experience in the healthcare, pharmaceutical, or biopharmaceutical industry.
- At least 3 years' experience in a supervisory or people management role.
- Strong understanding of GMP requirements and regulatory frameworks.
- Demonstrated expertise in quality and compliance decision-making.
- Excellent attention to detail and a strong commitment to quality standards.
- Ability to make informed quality decisions while maintaining a strong focus on patient safety and product integrity.
