Compliance Manager - Toronto, Canada - Centre for Commercialization of Regenerative Medicine

Centre for Commercialization of Regenerative Medicine

Verified Company

Toronto, Canada

3 weeks ago

Posted by:

Sophia Lee

beBee Recruiter

Description

About CCRM:

Position Summary

As a Compliance Manager at CCRM on the Deliver team, you are an experienced individual in the field of GMP manufacturing of regulated products who is driven by the opportunity to enable clinical translation of cell and gene therapies.

You are responsible for managing 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 site.

You will manage 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 will ensure 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 "culture of quality" across the organization.

Responsibilities:

Manage implement and maintain an externally facing quality management system, including materials management, vendor management, and audits (internal, external and 3rd party).
Manage supplier audit program to support GMP operations.
Lead review and management of Quality Agreements and Validation protocols for Facility & Equipment, Computer Systems and Software.
Manage system for approval of deviation investigations and implementation of corrective actions and preventative actions and change controls.
Monitor and manage the 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.
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 identified, consistent with quality and regulatory requirements.
Perform trending and reporting of Quality Performance Indicators for monitoring the overall health of the quality system.
Manage team to develop, draft, review, and approve specific SOPs, specifications, manufacturing batch records, and other documents in accordance with GMP regulations.
Manage internal audits 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, perform key audit roles/functions, and follow-up on audit observations related to compliance issues.

Assist in the preparation of regulatory documents.
Ensure proactive performance management having annual performance appraisals and career development plans in place for all employees in the department. Routinely work with direct and indirect reports to comanage their career development.
Be an active member of the Quality & Compliance Management team and help support continuous quality improvements.
Represent CCRM and promote its mission and capabilities to the cell and gene therapy field through participation at conferences, symposia, other venues, 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.
Continuously grow and adapt in a fastmoving field to keep yourself and the organization at the forefront of the cell and gene therapy and regenerative medicine fields.

Requirements:

BSc (bioengineering, chemical engineering, bioprocess, biotechnology, cell biology, microbiology, chemistry, etc.).
10+ years of experience in cell therapy/viral, or a contract manufacturing organization, quality department supporting GMP production, or within the pharmaceutical, biologics, or similar industries.
Proven experience in project leadership roles (team lead, project lead).
Proven experience in management of electronic Quality Management systems and extraction of complex data for continuous improvements to Quality systems
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.
Must be able to travel domestically and internationally up to 20 percent of the time.
Advanced understanding of quality management systems used in health product manufacturing environments.

Desired Characteristics