QC Lab Manager
This Leadership position reports directly to the Quality Director.
Manages and provides strategic direction to laboratory business units consisting of one of the following disciplines: API Laboratory Operations, Finished Goods Laboratory Operations, Raw Material/In-Process Laboratory Operations, Laboratory Support Operations, Laboratory Continuous Improvement/Compliance Operations and Microbial Environmental Controls.
Key Responsibilities Include:
- Manage a large team of lab supervisors and analysts. Is 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. Assure training and development of subordinates. Assist subordinates in problem solving. Identify and resolve personnel issues without direct supervision.
- 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.
- Directs area of responsibility to meet production objectives within planned budgets. Provides input to management for resources needed to construct budget, updates, and changes in financial plan. Manages area supplies and equipment within budgeted amounts.
- Establish and execute plans and commitments consistent to Development, Manufacturing, Customers and Business needs.
- Conceives, designs, conducts, and advanced independent scientific research 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.
- Conceives, design, and executes 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.
- Applies advanced technical writing skills to prepare project protocol, and final reports to support product registration and/or business needs.
- Conducts business and interacts/ negotiates with external contacts and customers to develop positive business relationships. Provides strategic direction for area of operation and ensures tactical objectives are met.
- Required - BS degree in Science or equivalent + 8 years of relevant experience OR
Master's degree in Science or equivalent + 6 years of relevant experience
Preferred - PhD in Science or equivalent + 4 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.
- 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