Supervisor- Quality Control, Data Review

We are seeking a dynamic individual to join our team as a Data Review Supervisor! As a Data Review Supervisor, you will be responsible for overseeing a business unit consisting of one of the following disciplines: API Laboratory Operations, Finished Goods Laboratory Operations, Environmental Monitoring, Raw Material/ In-Process Laboratory Operations, Laboratory Support Operations, Laboratory Continuous Improvement/Compliance Operations, Stability, Validation and support Regulatory Submissions. Your main responsibilities will include managing, leading, training and developing your team to ensure that the department has the appropriate talent and level of performance to meet business objectives. You will also be responsible for problem solving and identifying and resolving people issues without direct supervision.

If you have a passion for leadership, problem-solving, and compliance, and are looking for an exciting opportunity to join a team of talented professionals, we encourage you to apply for this position.

Responsibilities: 

• Manage, lead, train and develop team to ensure that the department has the appropriate talent and level of performance to meet business objectives. 
• Assist subordinates in problem solving.  Identify and resolve people 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.
• Direct area of responsibility to meet production objectives within planned budgets. Provide input to Supervisor for resources needed to construct budget, updates, and changes in financial plan. Supervise area supplies and equipment within budgeted amounts.
• Establish and execute plans and commitments consistent to Development, Manufacturing, Customers and Business needs.
• 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, interact and negotiate with external contacts and customers to develop positive business relationships.

• Bachelor's Degree in Science or in-lieu of a degree, an equivalent years of experience is preferred.
• Minimum 8 years of relevant Quality Control Lab, Data Review, GMP experience. Previous supervisory or team lead experience preferred.
• Demonstrated experience with high level of technical skill in technical lab operations and good understanding of related business.
• Knowledge in Product Quality, Quality Control Lab Operation and Regulatory requirements is required.
• Ability to work independently and make operational and business decisions to meet operational goals and business needs.
• Experienced in developing team and managing the budget.
• Skilled in interacting and establishing a positive interaction with internal and external customers.
• Shows broad understanding of the issues relevant to technical/science and business
• Strong creative problem solving and analytical skills.