The Director of Quality for Jazz Pharmaceuticals Ireland Manufacturing & Development will support the quality oversight of the Athlone Manufacturing facility. This role is responsible for the day‑to‑day management and execution of key quality assurance activities related to the manufacture of commercial and investigational medicinal products. Core responsibilities include oversight of quality systems, management of quality technical agreements, support for product release activities, and liaison with regulatory authorities at the local level. The Director of Quality is also responsible for ensuring that the management of controlled substances on site complies with applicable legislation.

The Director will be based in Athlone and will report to the VP of Global Quality, and is a member of the Global Quality Leadership Team (GQLT), with a close working relationship with the Athlone Site Leader.

The primary focus of this position is to ensure effective quality systems and cGMP oversight to support the reliable and timely supply of commercial products. The role also contributes to product and process development support across the organisation, promotes a strong quality culture both internally and with external partners involved in internal manufacturing, and ensures that robust procedures and controls are in place to govern key cGMP processes and maintain regulatory confidence. The role requires an individual who meets the educational and experiential criteria to act as a Qualified Person (QP).

Essential Functions

• Develop, implement, and maintain site quality systems to ensure compliance with applicable regulatory requirements as well as Jazz policies, procedures, and quality strategies.

• Oversee Quality activities associated with internal manufacturing, including support during regulatory inspections, oversight of intermediate and finished‑product manufacturing operations, participation in batch disposition activities (either as a QP or by supporting other site QPs), and collaboration with Quality Control.

• Act as the Responsible Officer for controlled substances on site, ensuring full compliance with relevant legislation, including the Misuse of Drugs Act 1977 (as amended) and associated regulations.

• Provide Quality input into Annual Product Quality Reviews (APQRs) and ensure ongoing fulfilment of related regulatory obligations.

• Develop and monitor site Quality KPIs and metrics, ensuring they effectively measure performance, drive continuous improvement, and support compliance with regulatory and corporate expectations.

• Represent the Quality function on cross‑functional project teams, providing quality oversight and contributing to project planning, execution, and decision‑making.

• Provide Quality input into development projects to ensure activities are executed in a compliant, scientifically sound, and operationally efficient manner.

• Support the establishment of material and product specifications, working collaboratively with Development, Manufacturing, and Quality Control functions.

• Engage with product development teams to provide Quality support and contribute to regulatory submissions as required.

• Support validation planning activities, including input into the site Validation Master Plan and oversight of validation deliverables from a quality perspective.

• Ensure a safe working environment by supporting the implementation of safe systems of work, providing appropriate information and training, and helping to maintain compliance with the Safety, Health & Welfare at Work Act 2005.

• Contribute to the development and implementation of site health and safety policies, ensuring adequate resources and promoting a culture of safety, compliance, and operational excellence.

Required Knowledge, Skills, and Abilities

• Highly flexible, works well in a team environment, and has necessary skills to organize, communicate, influence and lead.

• Demonstrated capability in establishing collaborative working relationships at all levels, regardless of seniority

• Possess fundamental scientific thought processes and demonstrated ability to apply this to overcome problems

• Recognize areas for improvement, and use initiative to implement change programs in support of progress

• Through leading by example, cultivate and nurture culture of collaboration and participation among the team.

• Foster a culture of change, innovation and self- improvement to maximise achievement of overall site goals

• Needs ability to maintain a calm disposition in the face of adversity

• Experience in design, commissioning, and validation of manufacturing facilities

• Experience in negotiating and managing quality agreements contracts

• Excellent communication skills, both oral and written

• Ability to lead and influence peers, superiors, and subordinates

• Ability to work well within a High Performing Team structure

Required/Preferred Education and Licenses

• A BSc/BA degree in science, Pharmacy or relevant field required. Advanced degree preferred

• Qualified Person (QP) eligibility required.

• More than 10 years quality experience in commercial manufacturing of pharmaceutical or similar products that are FDA & EU regulated

• Experience leading successful regulatory audits (HPRA, FDA)

Description of Physical Demands

Responsibilities may require working outside of “normal” hours, in order to meet business demands.