Associate Director QA is required by CareerWise Recruitment for our Meath based client. This position is a key leadership position that will provide QA direction for New Product Introduction (NPI) as a commercialisation site. The overall responsibility for this role will be to manage, plan and direct QA on site by supporting QA Operations, Disposition and QA Systems.
Role of this position
- Strategic QA oversight and leadership at the Biologics facility to meet functional and site goals and objectives.
- Responsible for QA (QA System, QA Operations, Disposition, Quality Risk Management (QRM) and Permanent Inspection Readiness (PIR))
- Hire, develop, lead and coach the QA team and drive a high-performance organizational culture that accommodates rapid growth and highly dynamic expectations, ensuring attainment of site operational and development goals.
- Responsible for adhering to domestic and international GMP regulations, cGMP's, company policies, leadership behaviours, performance and budget management.
- Responsible for the management of site QMS (Change control, Document Management, SQM, Deviation Management & CAPAs, PIR, QRM, Customer Complaints, Returns & Recalls and APQRs.
- Minimum of level 8 Bachelor's degree in a technical discipline (e.g. biochemistry, chemistry, microbiology) or equivalent.
- At least 12 years' experience in the biotechnology and/or pharmaceutical industry (preferably both).
- Proven leader capability in developing people and teams with at least 8 years of management experience.
Please call Mike Morrissey today for further information on 021-429 7536 or email: email@example.com
CareerWise Recruitment (In Search of Excellence)