We are currently sourcing a high calibre Senior QC Lab Manager to lead our diverse, technical lab team in Sligo.
We are currently sourcing a high calibre Senior QC Lab Manager to lead our diverse, technical lab team in Sligo. Reporting to the Quality Director, the successful candidate will manage API & Drug Product (DP) Laboratory Operations, Finished Goods, Raw Material/ In-Process and Laboratory Continuous Improvement/Compliance Operations.
In this role, you will:
Key Responsivities Include:
Education & Experience:
- Manage a team of Supervisors and Lab Analysts and be responsible to hire, lead and develop team members to ensure that the department has the appropriate talent and level of performance to meet business objectives.
- Ensure training and development of your team and building technical problem solving capabilities.
- Coach and mentor Supervisors to identify and resolve people issues.
- Assure conformance to all government and corporate regulations. Responsible to develop, provide, defend, persuade Corporate/Plant practices with outside organizations. Routinely meet with regulators (FDA & EU) and customers to ensure no interruption in business due to compliance issues.
- Meet production objectives within planned budgets, providinh input to Director for resources needed to construct budget, updates, and changes in financial plan. Manage area supplies and equipment within budgeted amounts.
- Establish and execute plans and commitments consistent to Development, Manufacturing, Customers and Business needs.
- Conceive, design, and conduct advanced independent QC activities per strategic business needs.
- Ensure research activities/projects are on track per business needs and established timeline.
- Develop, negotiate, finalize timeline and cost estimates for projects and/or service contracts to support business operations and/or external customer’s needs.
- Conceive, design, and execute projects related to the strategic needs of the business operations.
- Provide timely testing or execution of in-process, raw materials, intermediates, API, finished goods, continuous improvement initiatives, QA training, laboratory equipment validation and stability depending on area of responsibility.
- Apply advanced technical writing skills to prepare project protocol, and final reports to support product registration and/or business needs.
- Conduct business and interact/ negotiate with external contacts and customers to develop positive business relationships.
- BSc degree in Science or equivalent and 10+ years of relevant experience OR MSc degree in Science and 8+ years of relevant experience OR PhD in Science or equivalent and 6+ years of relevant experience.
- Must be experienced and demonstrate high level of technical skill in technical lab operations and good understanding of related business.
- Related knowledge in Product Quality, Quality Control Lab Operation and Regulatory requirements is required.
- Prior experience of liasing with key regulatory bodies HPRA, FDA etc
- Ability to work independently to meet operational goals and business needs.
- Ability to develop, design, execute and manage complex research programs.
- Ability to make operational and business decisions with minimum direction from immediate manager.
- Must have knowledge and skill in personnel management, and develop and managing budget.
- Ability to interact and establish positive interaction with internal/external customers.
- Shows broad understanding of the issues relevant to technical/science and business.