Director of Quality (QP/RP)

Position Responsibilities:

• Quality Systems & Leadership:
• Assist in the development and maintenance of the QMS in accordance with EU GMP EudraLex Vol. 4 and EU GDP (2013/c 343/01) requirements. 
• Provide quality oversight for operations and ensuring product quality, compliance and batch certification/release.
• Participate in Quality Management Review meetings, ensuring effective communication of quality metrics and continuous improvement initiatives.
• Ensure effective stakeholder engagement and collaborate cross functionally to achieve quality objectives.
• Ensure effective mechanisms of escalation are in place to effectively manage communication of significant quality events.
• Qualified Person (QP) in accordance with Directive 2001/83/EC, Article 51:
• Act as Qualified Person in accordance with EU GMP, including explicit compliance with Annex 16 and the terms of the Marketing Authorisation.
• Certify batches for release to the market or for export, ensuring that products are manufactured and tested in compliance with EU GMP, the marketing authorisations and relevant legislation.
• Ensure third-party manufacturing sites and testing laboratories are appropriately qualified, audited and compliant. 
• Provide QP oversight for importation activities, ensuring appropriate testing, certification and documentation for imported medicinal products.
• Maintain knowledge and qualifications status in accordance with HPRA QP registration requirements.
• Exercise independent authority for batch disposition and escalation of quality and compliance risks to senior management.
• Responsible Person in accordance with EU GDP Guidelines Section 2:
• Ensure wholesale distribution operations comply with GDP principles and the company’s WDA.
• Ensure the initial and on-going verification of suppliers and customers of medicinal product is in scope of the WDA. 
• Oversee the maintenance of distribution records, recall readiness, complaint management and falsified medicines reporting. 
• Support training of staff involved in GDP operations and monitor on-going competence.
• Act as point of contact with the HPRA for GDP-related matters.
• Ensure GDP-related deviations, complaints, recalls and CAPAs are appropriately assessed and managed.
• Global Quality Oversight:
• Provide quality oversight for global supply chain activities under the remit of the Irish entity.
• Ensure all outsourced activities are governed by effective Quality Technical Agreements and subject to ongoing performance monitoring.
• Collaborate with U.S. and global Quality counterparts to ensure consistent quality standards, release practices, and escalation pathways across regions.
• Support alignment of quality processes and practices across global affiliates and Marketing Authorisation Holders.
• Provide expert input into risk assessments, deviation/CAPA management, annual product quality review, and global quality improvement initiatives.
• Compliance, Inspection & Audits and Continuous Improvement:
• Serve as the primary point of contact for HPRA inspections and EU regulatory interactions related to the Irish entity.
• Ensure on-going HPRA inspection readiness for both the WDA and MIA, participate in inspection and response preparation activities.
• Ensure inspection readiness and timely closure of CAPAs, including effectiveness checks and documented follow-up.
• Lead and participate in internal audits and self-inspections, ensuring continuous improvement and compliance.
• Oversee the investigation and closure of deviations, CAPAs, complaints and change controls. 
• Drive risk-based quality improvement projects and promote a strong compliance culture across operations. 
• Monitor changes in GMP/GDP legislation, HPRA guidance and ICH standards implementing updates as required.

Candidate Requirements:

• Degree in Life Sciences, Pharmacy or related discipline.
• Eligible to act as Qualified Person (QP) and Responsible Person in Ireland.
• Demonstrated experience with both GMP (MIA) and GDP (WDA) virtual manufacturing and wholesale environments. 
• Strong working knowledge of GxP regulations, international quality standards and distribution requirements.
• Substantial experience acting as a QP for biologics and/or sterile products preferred.
• Demonstrated experience supporting HPRA and/or EMA inspections.
• Strong knowledge of EU GMP, GDP, Annex 16, and virtual/outsourced manufacturing models.
• Ability to operate independently and confidently in a regulator-facing role.
• Hybrid role to be based in Ireland, with availability to support on-site regulatory inspections and partner oversight.
• Strong communication and stakeholder engagement skills.
• Experience with biologics and sterile manufacturing.
• Ability to work effectively in a dynamic, fast-paced and global environment.
• High integrity and a commitment to patient safety and product quality.