A Site Quality Director is required by Careerwise recruitment to work with our Clare based biotech client.
Role of this position
- Provide and demonstrate leadership, championing the overall quality strategy and direction for the site assuring the site is GMP compliance with applicable regulations and company QMS.
- Lead the process with the relevant regulatory authorities to gain the necessary site licence approvals on time as required to support business strategies.
- Recruit and develop a high performing Quality Team. Lead the team in all aspects of the people process including hiring, on-boarding, mentoring, coaching, annual objective setting, performance management and development.
- Responsible for resource management and for initiating timely resource planning for the Quality department based on project plan and business needs. Ensure that Quality resources and competences at all times are supporting business goals, challenges and strategies.
- Ensure that analysis are transferred, validated and equipment qualified in compliance with applicable GMP rules and regulations and company QMS.
- Responsible for preparing, hosting and follow up on the escalation Review Board and for ensuring timely communication and notification internally and with external regulatory authorities
- Prepare for, and host, successful site regulatory inspections and/or partner audits. Lead the resolution of any findings and of the response in a timely manner.
- 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, including Computer System Validation e.g. EU/FDA GMP guidelines, EU Annex 15, PIC/S & GAMP guidelines, CPV, EU Annex 11 & CFR Part 11 and ICH guidelines.
Please call Michael O'Connor today for further information on 091-452410 or email email@example.com
CareerWise Recruitment (In Search of Excellence)