Job Description

As a Supervisor, Compliance, at CCRM, you are an experienced individual in the field of Good Manufacturing Practices (GMP) manufacturing of regulated products and driven by the opportunity to enable clinical translation of cell and gene therapies. You are responsible for overseeing the quality management system and monitoring quality performance indicators. You are also responsible for continuously monitoring and ensuring overall compliance of activities carried out at the site. You will supervise and develop CCRM\'s Compliance team to deliver on client demands, including fee-for-service work, contract manufacturing, access services, technology transfer, training, and technical and process development services to cell and gene therapy developers. You will provide technical expertise and will be responsible for management of client audits, communication to customers and leadership, and ensuring the high-quality delivery of contract services.
You will be a leader in understanding how to overcome compliance challenges for cell manufacturing and testing, to enable life-saving advances in cell and gene therapies.
You act as a champion for building a \xe2\x80\x9cculture of quality\xe2\x80\x9d across the organization.

Responsibilities

Implement and maintain an externally facing quality management system, including materials management, vendor management, and audits (internal, external, and third-party).
Implement supplier audit program to support GMP operations.
Lead the review and management of quality agreements, and validation protocols for facility, equipment, computer systems and software.
Implement a system for approving deviation investigations and the implementation of corrective actions, preventative actions (CAPA) and change controls.
Monitor and manage the Corrective and Preventative Actions (CAPA) system, including evaluation of CAPA records for appropriate plans and actions, monitoring timely completion and CAPA effectiveness. Analyze CAPA data and monitor for emerging trends.
Lead the team to develop, draft, review and approve specific standard operating procedures (SOPs), specifications, manufacturing batch records (MBR), and other documents in accordance with GMP regulations.
Manage the development and maintenance of the quality management system.
Develop and maintain metrics and reporting tools to monitor and review compliance activities such as Investigation and CAPA management at the site. Act as lead to respond to issues and concerns, consistent with quality and regulatory requirements.
Perform trending and reporting of quality performance indicators for monitoring the overall health of the quality system.
Implement internal audits, audit for facilities and systems for compliance to SOPs and GMP regulations.
Manage audits by clients and regulatory authorities.
Provide necessary support during regulatory inspections, which may include provision of pre-requested documents, performing key audit roles/functions, and following-up on audit observations related to compliance issues.
Assist in the preparation of regulatory documents.
Be an active member of the Quality & Compliance Management team and help support continuous quality improvements.
Ensure proactive performance management by having annual performance appraisals and career development plans in place for all employees in the department. Routinely work with direct and indirect reports to co-manage their career development.
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 the CCRM values of purpose, integrity, excellence, accountability, and collaboration, and motivate others to do the same.
Evolve in a fast-moving field 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.).
8+ years of experience in cell therapy/viral vector, or a contract manufacturing organization, or a quality department supporting GMP production, or within the pharmaceutical, biologics, or similar industries.
Proven experience in project leadership roles (team lead, project lead).
Strong understanding of manufacturing processes and technologies.
Sound knowledge of 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 20 per cent of the time.
Advanced understanding of quality management systems 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, 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 deliver high-quality outcomes.

CCRM