Job Specifications
Active Vacancy
Job Title: Compliance Associate
Revision No.: OBCOMPASSOC-2024117
Department: Supply Chain, Manufacturing, Facilities & Engineering
Working Arrangement: On Site
About OmniaBio:
OmniaBio 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, OmniaBio 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, OmniaBio provides its clients with comprehensive services from preclinical to commercial manufacturing to help streamline the path to market for these transformative treatments. OmniaBio 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. OmniaBio is poised to meet the surging global manufacturing demand, enabling access to transformative treatments for patients around the world. Please visit www.omniabio.com 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.
Generates departmental KPI adherence reports. Use SAP to create departmental metrics.
Support vendor/supplier management system.
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 development.
Builds and maintains a trusted and respectful relationship with other department stakeholders.
Assists in a timely manner with investigations for out-of-specification incidents.
Assists with addressing audit observations (internal, client, regulatory) and ensures timely closure.
Identifies and helps resolve departmental compliance issues.
Familiar with current ALCOA principles.
Experience with electronic quality document management systems (QMS), and root cause analysis methodologies.
Requires a flexible work schedule, which may include shift work and weekends to support operating schedules, facility requirements, and/or responding to call-in emergency situations.
Completes special projects and reports, as needed.
Other duties as assigned, including department-wide projects.
Performs cross-functional and/or other duties as assigned or requested. For example, assists other departments with com
About the Company
OmniaBio is redefining the future of cell therapy manufacturing through its proprietary AI-powered Intelligent Factory(tm). Purpose-built to accelerate discoveries and industrialize production, the Intelligent Factory(tm) integrates artificial intelligence and automation across the entire manufacturing lifecycle. With a focus on autologous CAR-T and other advanced therapies, OmniaBio's platform enables scalable, efficient, and high-fidelity production by embedding predictive analytics, robotic bioprocessing, and digital qual...
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