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Quality Control Operations Manager

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Proclinical

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Location:
Australia , Melbourne

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Category:
Quality Control

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Contract Type:
Not provided

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Salary:

115000.00 - 135000.00 AUD / Year
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Job Description:

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.

Job Responsibility:

  • 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

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

Nice to have:

  • Knowledge of PIC-S annexes 1 and 2
  • experience participating in audits

Additional Information:

Job Posted:
May 05, 2026

Employment Type:
Fulltime
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