This company is one of the world's leading pharmaceutical companies. Through acquisitions and mergers, this company has expanded rapidly in its short history and now boasts more than 10,000 employees, and offices in more than 40 countries. This organisations growth strategy is to focus on developing and marketing innovative speciality medicines for symptomatic conditions to meet significant unmet patient needs. Their strategic priorities are to drive optimum performance of their existing products, enabling access to these medicines for patients today and building their pipeline through research and development and business development delivering access in the future for patients. Due to continued expansion, an exciting new position has arisen in the organisation for a Director of Quality & QP for their manufacturing plant in North Dublin in addition to responsibilities covering two other sites in the organisation's network.
- Day to day leadership for Quality aspects of the facility including QC testing, QMS implementation and oversight.
- Member of the plant management team for the site manufacturing facility which decides and implements strategy and direction.
- Certification and Release of API lot(s) in accordance with EU & US CGMP requirements.
- Eligible to perform the Qualified Person (Q.P.) role in accordance with the legislative requirements within Article 51 of Directive 2001/83/EC and Article 55 of Directive 2001/82/EC3.
- Creation, governance and maintenance of the manufacturing facility Quality Management System as defined through the Site Master File, Technical Agreements, SOPs and Eudralex - Vol.4 GMP Guidelines.
- Oversight and Governance of all Product/Technical Transfer(s) with 3rd parties from a Quality perspective.
- Authorisation and Approval of Change Records, Validations and Qualifications.
- Leading the Quality unit within the manufacturing facility.
- Communication with Competent Authorities as and when required.
- Governance of all External and Internal audit programmes and plan, executing and following up on supplier site visits due to identified issues, validation/transfer activity or as routine periodic visits.
- Responsible for ongoing inspection readiness program to ensure that Quality System is managed and maintained in accordance with ICH Q7 and ICH Q10.
- Management and development of members of the plant Quality Team.
- Identify, develop and execute project plans and timelines to achieve desired results.
- Lead continuous improvement efforts for projects identified at the suppliers or within the plant.
- Serve as the leading technical expert in one or more key quality or compliance areas.
- B.Sc in chemistry or related science minimum.
- Qualified Person status is preferred.
- 10-15 years Pharmaceutical related experience.
- 10+ year's experience in a managerial role.
- Expert knowledge of cGMP requirements.
- Strong working knowledge of FDA and EU requirements and guidance documents.
To discover more about this opportunity, apply now or contact Shane Browne at HRM on +353 1 632 1865 for a confidential discussion.