Quality Assurance Director, Permanent, Co Clare
Reporting into the VP of Quality this is a great opportunity for someone looking to relocate home to the mid-west or someone looking for a new career challenge!
This position will suit someone with start-up experience combined with commercial manufacturing experience.
Full relocation package provided.
Pharmaceutical or Bio-Pharmaceutical industry experience required!
For further information please contact me for a full job description or more detailed information on this role!
Purpose of Job
- Responsible for the QA and QC departments on the site.
- Co-own, together with the Head of QC (UK), the QC Internalisation Strategy and is responsible for ensuring this is implemented in a timely manner in accordance with business needs.
- The QD is a member of the Sites leadership team and the Quality Leadership team
Qualifications and Education Requirements
- BSC/MSC/PhD in a Science discipline.
- Experience as Site quality Director is essential.
- Extensive knowledge and understanding of pharmaceutical Quality Assurance and GMP experience within a manufacturing stat up project. This knowledge must be combined with clear decision making, pragmatism aligned with quality risk management principles to demonstrate release of product for clinical and commercial use
- Minimum 5 years’ experience in supporting and providing QA/QC oversight to validation activities and with and implementing the concepts, legislation, guidelines, and requirements related to qualification and validation of products, processes, equipment and systems
- Extensive Operational knowledge of GMP Operations and Quality Systems required for a sterile manufacturing facility applying and understanding of the principles of sterile manufacturing
- Eligible to act as a ‘Qualified Person
- Proven ability to make sound decisions regarding evaluation of GMP compliance, and leadership abilities in the management of QA oversight
- Proven ability to work in an ambitious, deadline-driven environment and handle multiple projects simultaneously
- A track record of recruiting, developing and leading high-performance teams
- Must be a team player prepared to lead, work in, and embrace a team-based collaborative culture
For further information or a confidential discussion please contact Deirdre Sheehan
086 046 4671