Quality Control Manager
We are seeking an experienced Quality Control Manager to join our team at a leading global biopharma company in Waterford, Ireland.
About the Role:
The successful candidate will be responsible for ensuring the provision of an efficient, independent product assessment capability to verify that all products are manufactured consistently, meeting pre-defined specifications and requirements.
* To lead all aspects of product quality testing proactively and in accordance with cGMP regulations.
* To ensure the availability of adequate facilities, trained personnel, and approved procedures for sampling, inspecting, and testing starting materials, packaging materials, intermediate, bulk, and finished products.
* To monitor environmental conditions for GMP purposes and improve cycle times in all QC related activities.
* To forecast and execute spending in accordance with agreed budgets and customer requirements.
* To provide people leadership to the team, including developing and maintaining succession plans for the QC teams.
* To contribute to the QO&MPT Leadership team and work collaboratively as part of the management team to achieve overall site success.
* To deploy available resources efficiently, including transferring resources between QC teams to meet varying workloads.
* To support operational cGMP compliance activities and HSE initiatives in line with site systems.
* To manage the safety performance of QC according to national legislation, site procedures, and other initiatives.
Requirements:
* Significant experience working in a cGMP manufacturing environment.
* Degree in Science (Chemistry, Microbiology, or Pharmacy preferred).
* Post-graduate studies may be advantageous.
* Previous Lab Management or Team Leader experience is essential.
* Operational experience of quality laboratories in a fast-moving manufacturing environment.
* Detailed knowledge of quality management systems.
* Effective technical knowledge of pharmaceutical plants.
* Knowledge of requirements for cGLP, pharmacopeial methods, and stability.
* Full understanding of relevant quality and compliance regulations.
* Able to manage projects to plan/budget.
* Effective facilitator.
* Good communication skills at organisation, team, and individual levels.