Supervisor, Quality Assurance Jobs

Job Title: Supervisor, Quality Assurance

About CCRM

CCRM, based in Toronto, Canada, is a unique not-for-profit group that is developing and commercializing cell and gene therapies and regenerative medicine technologies. We are leveraging our network of academics, industry partners and investors to tackle significant problems and advance our most promising technologies to the market to meet the needs of patients. For more information about CCRM, please visit our website at ccrm.ca.

Position Summary

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

• Act as a mentor for team members and new employees.
• Represent CCRM and promote its mission and capabilities to the cell and gene therapy field through participation at conferences, symposia, etc., and customer visits.
• Oversee the review and approval of master documents, executed documents and summmary reports as applicable.
• 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.
• Oversee the teams to maintain proper GMP in everyday tasks.
• 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.
• Implement key process improvements to enhance systems, gain site efficiencies, and elevate GMP requirements to continuously improve.
• Continuously grow and adapt in a fast-moving environment.
• Implement and maintain a QA training program to meet QA training needs that align with CCRM needs.
• Demonstrate the CCRM values of purpose, integrity, excellence, accountability and collaboration, and motivate others to do the same.
• Train, coach and guide the team in day-to-day activities.
• Support the Quality Manager and/or Quality Director in all aspects of the quality management system.
• Coordinate with clients and third-party contract services to ensure quality guidance is provided as needed.
• Oversee the Quality Assurance (QA) team and manage client projects, providing quality inputs to project management.
• Review and approve deviations, corrective and preventative actions (CAPA), change controls, standard operating procedures (SOPs), etc.
• Additional duties, as assigned.
• Liaise with academic and industry partners to ensure meaningful engagement and collaboration.

Requirements

• 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.
• Bachelor’s degree in Science (Bioengineering, Chemical Engineering, Bioprocess, Biotechnology, Cell biology, Microbiology, Chemistry etc.). Master’s degree is preferred.
• Independent, detail-oriented, self-starter with excellent analytical skills and the ability to multitask and succeed in a team environment.
• 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.
• Experience establishing customer-facing organizations and service models.
• Demonstrate initiative and the ability to oversee delivery of high-quality outcomes.
• Strong English written and oral communication skills.
• Strong understanding of quality management systems used in cell therapy product manufacturing environments.
• Experience working for a contract manufacturing organization, a third-party testing facility, or a biotechnology company performing similar activities.
• Strong understanding of cell manufacture processes and technologies.
• Leadership and team supervisory experience.
• Sound knowledge and experience in management of current GMP (cGMP)/GMP requirements,
• Must be able to travel domestically and internationally up to 10 per cent of the time.

CCRM is a developing organization and represents a fluid working environment. Flexibility and adaptability are essential, and duties will be influenced by the needs of the organization.

Applicants must be legally eligible to work in Canada and prepared to travel internationally.

CCRM is committed to accessibility, diversity, and equal opportunity. Requests for accommodation can be made at any stage of the recruitment process, providing the applicant has met the bona fide requirements for the open position. Applicants should make their requirements known once contacted to schedule an interview, or when the job offer has been made.