Are you passionate about quality and precision? Join our client in this Quality Control Operations position and help ensure top-tier standards every day.
探花合集 is seeking a Quality Control Operations Manager to oversee the daily operations of a quality control team focused on cell therapy products. This role involves ensuring compliance with GMP regulations, managing quality control testing, and fostering a collaborative and high-performing team environment. The position requires strong leadership skills, technical expertise in quality control methods, and a commitment to operational excellence.
Responsibilities:
- Manage daily quality control activities to ensure timely and efficient testing of cell therapy products while maintaining high standards of quality and compliance.
- Coordinate QC lab scheduling and tracking to meet business deadlines.
- Monitor resource utilization to maximize efficiency and minimize downtime.
- Ensure teams are trained and adhere to GMP procedures and quality control standards.
- Collaborate with internal teams to ensure facilities meet operational requirements and remain fit for purpose.
- Participate in internal audits and prepare for external audits.
- Support investigations and documentation of non-conformances and out-of-specification results.
- Implement corrective and preventive actions (CAPA) for deviations in testing processes.
- Lead the implementation of new quality control procedures and projects.
- Foster a culture of continuous improvement, innovation, and operational excellence.
- Provide leadership, mentoring, and effective delegation to build a cohesive and collaborative team.
- Perform quality control scientist activities as needed, ensuring adherence to SOPs and cGMP requirements.
- Promote health, safety, and environmental objectives within the team, ensuring safe systems of work and compliance with HSE policies.
Key Skills and Requirements:
- Strong understanding of GMP regulations and quality control methods related to cell therapy products.
- Proficiency in QC testing platforms such as flow cytometry, PCR, potency, and safety tests.
- Knowledge of scientific principles, assay validity requirements, and procedures for handling invalid assays and out-of-specification results.
- Proven leadership experience in a quality control environment.
- Excellent problem-solving, organizational, and communication skills.
- Ability to work effectively in a fast-paced, dynamic environment.
- Understanding of equipment qualification and maintenance.
- Commitment to fostering team growth, collaboration, and psychological safety.
- Desirable: Knowledge of PIC-S annexes 1 and 2 and experience participating in audits.
If you are having difficulty in applying or if you have any questions, please contact Pamela Phoumavong at p.phoumavong@proclinical.com.
If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.
探花合集 is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. 探花合集 is acting as an Employment Agency in relation to this vacancy.
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