We have a new opportunity for a Quality Control Director for our Pharmaceutical Manufacturing client based in Dundalk. This position will be a key member of their Quality site leadership team with responsibility for all aspects of the Quality Control laboratories including the GMP sustaining operations requirements to ensure that all local and Global regulations are adhered to. The role will be responsible for providing the necessary leadership across all site Quality Control Developing key relationships with external stakeholders and customers will also be critical requirements of this position in order to ensure the achievement of the business goals and long-term strategy.
Overview of your responsibilities (full job description available on request):
- The role will require extensive liaison with counterparts and business leaders to include the highest level of professional representation of the local site Quality Control organisation.
- Develop the overall Quality Control strategy aligned with the facility’s strategic business plans and global QC testing strategy.
- Develop and implement the strategic objectives for the QC team
- Provide leadership and direction for all site QC activities i.e. safety, quality, cost, inventory and stock management, resource allocation and re-prioritisation.
- Build and develop a high performing QC management team.
- Work with the Site Quality Head and the HR function, to measure the QC team’s performance against Key Performance Indicators.
- Ensure the engagement of the team with Learning and Development initiatives and the performance management system for the site.
- Develop a culture of continuous improvement, recognition, and constructive feedback for the team.
- Identify and drive opportunities to achieve optimal and cost-effective productivity for the facility related to testing requirements
- Provide direction to the QC team with regard to achieving customer service requirements within defined timelines.
- Collaborate with other members of the leadership team to plan requirements for future capacity
- Lead the implementation of cost improvement activities and the outsourcing of testing as required.
- Ensure the efficient and safe execution of QC testing and drive assay robustness to reduce deviations in QC.
- Lead the QC team to ensure best value is achieved by driving lean cGMP testing practices and/or OPEX principles.
- Provide direction and expertise on complex compliance issues and ensure the QC team operates in accordance with relevant regulatory standards.
- Provide direction to the QC team to ensure expectations of quality, delivery and cost are met by implementing appropriate processes to assess and manage all relevant risks
- Interface with Regulatory bodies as required, representing the site to relevant authorities and regulatory inspectors in matters relating to production management, quality, safety and risk.
Knowledge, Skills, and Experience Required for the Role:
- Degree qualified in relevant Science discipline with a master’s qualification being beneficial.
- Ideally More than 15 years of experience in Pharmaceutical/Biopharma manufacturing environment with a well-rounded exposure to all areas, including organisation design, recruitment & selection, talent development, performance management, employee relations, employee engagement and HR policies and processes.
- Extensive experience of relevant QC processes and systems in a highly regulated testing environment.
- Ideally experienced in a range of QC disciplines including Microbiology, Analytical protein analysis, Bioassays & Raw Material testing, Maintenance and Project Management.
- Demonstrable ability to influence senior managers, build strong relationships and drive a global QC testing strategy.
- Excellent strategic/business planning, budgeting and reporting experience.
- Previous experience with regulatory inspections and internal/customer audits is strongly preferred
- Excellence in leadership, providing clear direction and focus to the QC team and wider business functions.
- Proven ability in leading a high performing team, setting the highest professional standards.
- Ability to interact well with all levels of staff, including senior management with excellent problem-solving capabilities.
For a confidential discussion and more information on the role contact Gillian Nicholsongillian.firstname.lastname@example.org
+353 01 6620088