Supervisor, Quality Control

Role Summary

This role is primarily responsible for reviewing data to ensure accuracy, compliance, and completeness within the team or department, while also providing people leadership. Key responsibilities include leading and developing team members, evaluating and interpreting data from various sources, ensuring adherence to regulatory and organizational standards, and identifying trends or discrepancies. The position involves coaching and supporting team members, fostering professional growth, and handling personnel issues as needed. Additionally, this role supports continuous improvement initiatives, prepares technical reports, and collaborates with both internal team members and external stakeholders to resolve data-related issues and maintain high standards of data integrity.

Responsibilities

• Supervise a team and 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 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.
• Directs area of responsibility to meet production objectives within planned budgets. Provides input to Supervisor for resources needed to construct budget, updates, and changes in financial plan. Supervises 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.
• 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.

Qualifications

• Required - BS degree in Science or equivalent
• 8+ years of relevant experience
• <3 years of supervisory 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 make operational and business decisions with minimum direction from immediate supervisor. Must have knowledge and skill in personnel supervision 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.