Job Description

As a Compliance Associate I at CCRM, you will be part of the field of Good Manufacturing Practices (GMP) in the manufacturing of regulated products and driven by the opportunity to enable clinical translation of cell and gene therapies. You will help support CCRM\'s Quality Assurance and Quality Control teams to deliver on client demands, including fee-for-service work, contract manufacturing, access services, technology transfer, training, technical and process development services for cell and gene therapy developers. You will be responsible for helping with client audits and communication to customers and leadership, and will ensure the high-quality delivery of contract services. You will be a leader in understanding how to overcome cell manufacturing and testing challenges to enable life-saving advances in cell and gene therapies.
Responsibilities:

Assist with maintenance of externally facing quality management system (QMS), including materials management, vendor management, audits (internal, external, and third-party), and quality support for client projects.
Review of deviation investigations and change controls, and implementation of corrective and preventative actions.
Assist with the maintenance of the ISO 9001 quality management system.
Provide support with the supplier audit program to support GMP operations.
Support and participate in audits by clients and regulatory authorities.
Assist end-users of the electronic QMS to provide training on use of quality systems, system maintenance and other quality procedures.
Work with team members to develop, draft and review specific documents (SOPs, specifications, etc.) in accordance with ISO 9001/GMP regulations.
Approve materials for release to use in GMP manufacturing.
Represent CCRM and promote its mission and capabilities to the cell and gene therapy field through participation at conferences, symposia, etc., and customer/supplier visits.
Interface with academic and industry partners to ensure meaningful engagement and collaboration.
Demonstrate CCRM\'s values of purpose, integrity, excellence, accountability, and collaboration, and motivate others to do the same.
Evolve in a fast-moving environment to keep yourself and the organization at the forefront of the cell and gene therapy industry and regenerative medicine field.

Requirements:

Bachelor\'s degree in Science (Bioengineering, Chemical Engineering, Bioprocess, Biotechnology, Cell Biology, Microbiology, Chemistry, etc.).
2-3 years of experience in cell therapy/viral vector quality group or a contract manufacturing organization quality department supporting GMP production, or within the pharmaceutical, biologics, or similar industries.
Strong understanding of manufacturing processes and technologies.
Familiarity with a Validation Master Plan (VMP), as well as qualification and validation principles.

Strong English written and oral communication skills.
Must be able to travel domestically and internationally up to 10 per cent of the time.
Advanced understanding of QMS used in health product manufacturing environments.

Desired Characteristics:

Sound knowledge of applicable regulatory frameworks and requirements for cell and gene therapy and regenerative medicine, such as GMP, ISO, ICH Q7, ATMP, FACT, 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 in supporting the establishment of customer-facing organizations and service models.
Demonstrated initiative and the ability to deliver high-quality outcomes.

CCRM