Are you passionate about quality and precision? Join our client in this Quality Control Operations position and help ensure top-tier standards every day.
Proclinical 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.
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