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Quality Assurance Supervisor
2 months ago
The Quality Control Manager is integral to the success of our quality assurance processes, ensuring that all QC functions effectively support both clinical and commercial production activities. This role is essential in maintaining the highest quality standards for all products manufactured at our facility.
Key Responsibilities- Lead and mentor a team of QC professionals, fostering their development and performance.
- Implement strategic hiring practices aligned with business objectives.
- Oversee QC staff in their duties, ensuring safe and efficient verification and approval of products.
- Delegate tasks and supervise laboratory personnel, providing guidance to enhance productivity.
- Ensure adherence to cGMP and GTP regulations, as well as company protocols.
- Facilitate consistent laboratory practices across multiple sites.
- Act as a key approver in investigations, ensuring timely resolution of deviation reports and change controls.
- Ensure all client QC requirements for GMP cellular products are met.
- Manage material dispositions through deviation reporting systems.
- Prioritize and coordinate multiple projects and resources effectively.
- Monitor the efficacy of quality systems and address audit findings.
- Investigate customer complaints and coordinate corrective actions related to Quality Control.
- Maintain and track the deviation reporting system.
- Develop and monitor Key Performance Indicators (KPIs) for laboratory testing.
- Collaborate with vendors and in-house teams to implement corrective actions for recurring issues.
- Engage with management for alignment on significant deviation resolutions.
- Oversee the development and implementation of Standard Operating Procedures for QC activities.
- Participate in budget planning and cost management initiatives.
- Maintain effective communication with senior management and business partners.
- Ensure compliance with company policies and legal standards.
- Complete special projects as assigned by the Global Quality Head.
- Be available for off-schedule shifts as required by business needs.
- Provide on-call support when physical presence is not feasible.
- Bachelor's or Master's degree in a scientific discipline is required.
- Advanced degree in Business Administration is preferred.
- 7 to 10 years of experience in the pharmaceutical or biologics industry.
- Prior experience in a cGMP environment is essential.
- Hands-on experience in QC laboratory operations, particularly in Flow Cytometry.
- Minimum of 5 years in a leadership role, demonstrating effective team management skills.
- Strong understanding of current Good Manufacturing Practices (cGMPs).
- Familiarity with routine QC laboratory procedures and production processes.
- Experience in reviewing and developing Standard Operating Procedures is advantageous.
- Proven track record in a supervisory or managerial capacity.
- Ability to formulate strategic plans based on business requirements.
- In-depth knowledge of Quality Control in the pharmaceutical and biotechnology sectors.
- Proficient in Microsoft Office and Visio.
- Exceptional communication and presentation skills.
- Strong analytical and problem-solving capabilities.
- Detail-oriented with the ability to manage multiple tasks in a dynamic environment.
While performing the duties of this position, employees may encounter various hazards and are expected to follow safety protocols diligently. This job description is intended to provide a general overview of the responsibilities and qualifications associated with the role and may be subject to change.
