Compliance Associate; Manufacturing

Compliance Associate (Manufacturing, 12-month contract)

This range is provided by Omnia Bio. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

CA $65,000.00/yr - CA $75,000.00/yr

Active Vacancy

Job Title
:
Compliance Associate

Revision No.: OBCOMPASSOC-2024117

Department
:
Supply Chain, Manufacturing, Facilities & Engineering

Working Arrangement
:
On Site

About Omnia Bio:

Omnia Bio Inc. is a technology-focused, global cell and gene therapy CDMO with a vision to manufacture a disease-free world. Strategically located at McMaster Innovation Park in Hamilton, Ontario, Omnia Bio harnesses over a decade of expertise in regenerative medicine and advanced therapies from CCRM. Offering comprehensive and tailored CDMO services, cutting-edge development, and reliable Good Manufacturing Practices capabilities, Omnia Bio provides its clients with comprehensive services from preclinical to commercial manufacturing to help streamline the path to market for these transformative treatments.

Omnia Bio specializes in immune cell-based therapies, induced pluripotent stem cell therapies and lentiviral vectors, driving advancements in the field, and bringing maturity to cell and gene therapy. Omnia Bio is poised to meet the surging global manufacturing demand, enabling access to transformative treatments for patients around the world. Please visit  to learn more.

Role

Summary:

The Compliance Associate will provide guidance, leadership and training to other Business unit personnel to meet compliance goals within the department, as per Good Manufacturing Practices (GMP) requirements. This role reports to the business unit leader. The Business Compliance Associate will be familiar with the different responsibilities required to maintain the facility in a GMP environment at a biomanufacturing contract development and manufacturing organization (CDMO).

The person hired will also have knowledge and experience with the facility, Supply Chain and Manufacturing systems used in such facilities, including environmental monitoring systems, equipment maintenance management systems, building and equipment automation systems, tasks and ticketing systems, understanding their structures, limitations and functionalities,

Responsibilities:

• Ensure compliance to GMP/Good Documentation Practice (GDP) and departmental procedures of executed documents.
• Generate and review departmental procedures relating compliance.
• Initiates, leads, performs investigations, co-ordinates activities, and completes deviation reports (e.g., incident reports, issue reviews) in a timely manner.
• Initiates, leads and performs impact assessments for change control.
• Manages departmental training program, identifies gaps in training and executes required follow up actions.
• Manages SOP periodic review cycle timelines to ensure timely review of departmental SOPs. This includes coordinating reviews by subject matter experts, revising the SOP, and preparing supporting Change Request (CR) documents.
• Leads cross-functional personnel to develop documented risk assessments and mitigation strategies for change controls (CRs) and corrective action preventive action (CAPA) plans, for Facility related changes/repairs.
• Monitors progress and deadlines for Facilities department quality related IR’s, CR’s, and CAPA’s and assembles required documentation to effectively complete quality objectives.
• Co-ordinates training activities for departmental staff, including quality management system (QMS) documents, and directing and presenting GMP-related training. This will include scheduling, preparation of materials, instructing/guiding personnel, and reviewing test results, as applicable.
• Prepares and participates in internal, client and regulatory audits as SME.
• Identifies potential areas of compliance risk in the facility; assist with development/implementation of corrective/preventative action plans.
• Possesses knowledge of the applicable regulatory frameworks and requirements for cell and gene therapy and regenerative medicine (e.g., GMP guidelines, Health Canada, U.S. FDA, EMA, ICHQ7, as well as ISO standards), or medical device…