Quality Manager
Location: Athlone, Ireland
Role Purpose
This is a senior, hands-on Quality Assurance role for an experienced QA professional with strong QMS experience and an interest in controlled drugs governance. Reporting to the Director of Quality, you will work closely with a small, dedicated QA team and have access to document control, specialist, and administrative support.
You will own a defined portfolio of QMS responsibilities, with the opportunity over time to take the lead on at least two full systems or programmes, such as supplier management, internal audits, QMR coordination, controlled drug reconciliations, or CAPAs/NCs, based on your strengths and experience.
Key Responsibilities
- Maintain and improve the Quality Management System (QMS) to meet GMP and regulatory standards.
- Take ownership of assigned QMS elements (e.g., deviation/CAPA management, change control, training, supplier oversight).
- Manage and close deviations and non-conformances, coordinating root cause analysis and CAPAs.
- Prepare summaries and trend analyses for site leadership.
- Record actions and decisions, tracking follow-up to completion.
- Support controlled drug activities, including reconciliations, documentation reviews, and investigations.
- Support planning, conducting, and following up on supplier and internal audits.
- Represent QA during internal and external audits within your scope.
- Provide QA input to projects such as new product introductions, process improvements, and updates.
- Communicate clearly with colleagues, external partners, and regulatory bodies.
Requirements
- Bachelor's degree in Chemistry, Pharmaceutical Sciences, Life Sciences, or related discipline.
- 5-10 years' experience in GMP QA, ideally in API or pharmaceutical manufacturing.
- Strong experience with QMS processes: deviation/CAPA management, change control, document control, audits, training.
- Experience supporting senior quality governance forums (QMRs).
- Proven ability to take ownership of QA projects and deliver independently.
Why Apply
This role is ideal for a senior QA professional seeking clearly defined responsibilities, hands-on work, and significant growth potential. You will have the chance to shape key quality systems and contribute to a strong QA culture within a high-potential, growing pharmaceutical site.
