Job Description

As a Supervisor, Quality Assurance, at CCRM, you are experienced in the field of Good Manufacturing Practices (GMP) manufacturing of cell and gene therapy products and driven by the opportunity to enable clinical translation of cell therapy and regenerative medicines. You will supervise and monitor CCRM\'s Quality Assurance team to deliver on client demands, including fee-for-service work, contract manufacturing, access services, technology transfer, training, technical and process development services to cell and gene therapy and regenerative medicine producers. You will provide technical expertise and ensure the high-quality delivery of contract services. You will play a supportive role to overcome cell manufacturing and testing challenges to enable life-saving advances in cell and gene therapy and regenerative medicine.

Responsibilities

Supervise quality-related services, including reviewing and approving master batch records (MBR), executed batch records (BR) and associated documents, logging time against client projects where appropriate, and providing inputs to project management.
Ensure support for Operations, Manufacturing Sciences and Technology (MSAT), Quality Control (QC), Supply Chain Management (SCM) and other areas when issues arise, to facilitate decision-making to assess batch impact. On-call support may be required.
Oversee the review and approval of master documents, executed documents and summmary reports as applicable.
Review and approve deviations, corrective and preventative actions (CAPA), change controls, standard operating procedures (SOPs), etc.
Oversee the teams to maintain proper GMP in everyday tasks.
Coordinate with clients and third-party contract services to ensure quality guidance is provided as needed.
Support the Quality Manager and/or Quality Director in all aspects of the quality management system.
Oversee the Quality Assurance (QA) team and manage client projects, providing quality inputs to project management.
Implement key process improvements to enhance systems, gain site efficiencies, and elevate GMP requirements to continuously improve.
Implement and maintain a QA training program to meet QA training needs that align with CCRM needs.
Represent CCRM and promote its mission and capabilities to the cell and gene therapy field through participation at conferences, symposia, etc., and customer visits.
Liaise with academic and industry partners to ensure meaningful engagement and collaboration.
Demonstrate the CCRM values of purpose, integrity, excellence, accountability and collaboration, and motivate others to do the same.
Continuously grow and adapt in a fast-moving environment.
Act as a mentor for team members and new employees.
Train, coach and guide the team in day-to-day activities.
Additional duties, as assigned.

Requirements

Bachelor\'s degree in Science (Bioengineering, Chemical Engineering, Bioprocess, Biotechnology, Cell biology, Microbiology, Chemistry etc.). Master\'s degree is preferred.
8+ years of experience in a cell therapy/viral vector quality department supporting GMP production, or similar within the pharmaceutical, medical technologies, biologics, or similar industries.
Experience working for a contract manufacturing organization, a third-party testing facility, or a biotechnology company performing similar activities.
Leadership and team supervisory experience.
Strong understanding of cell manufacture processes and technologies.
Strong English written and oral communication skills.
Must be able to travel domestically and internationally up to 10 per cent of the time.
Strong understanding of quality management systems used in cell therapy product manufacturing environments.
Sound knowledge and experience in management of current GMP (cGMP)/GMP requirements,
applicable regulatory frameworks and experience in implementation of requirements for cell and gene therapy and regenerative medicine, such as cGMP/GMP, ISO, or medical device development.
Independent, detail-oriented, self-starter with excellent analytical skills and the ability to multitask and succeed in a team environment.
Experience establishing customer-facing organizations and service models.
Demonstrate initiative and the ability to oversee delivery of high-quality outcomes.

CCRM