Compliance Associate

1. Ensure compliance to GMP/Good Documentation Practice (GDP) and departmental procedures of executed documents.
2. Generate and review departmental procedures relating compliance.
3. Generate departmental KPI adherence reports. Use SAP to create departmental metrics.
4. Support vendor/supplier management system.
5. Initiate, lead, perform investigations, coordinate activities, and complete deviation reports (e.g., incident reports, issue reviews) in a timely manner.
6. Initiate, lead and perform impact assessments for change control.
7. Manage departmental training program, identify gaps in training and execute required follow up actions.
8. Manage 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.
9. Lead 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.
10. Monitor progress and deadlines for Facilities department quality related IRs, CRs, and CAPAs and assemble required documentation to effectively complete quality objectives.
11. Coordinate 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.
12. Prepare and participate in internal, client and regulatory audits as SME.
13. Identify potential areas of compliance risk in the facility; assist with development/implementation of corrective/preventative action plans.
14. Possess 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.
15. Build and maintain a trusted and respectful relationship with other department stakeholders.
16. Assist in a timely manner with investigations for out-of-specification incidents.
17. Assist with addressing audit observations (internal, client, regulatory) and ensure timely closure.
18. Identify and help resolve departmental compliance issues.
19. Familiar with current ALCOA principles.
20. Experience with electronic quality document management systems (QMS), and root cause analysis methodologies.
21. 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.
22. Complete special projects and reports, as needed.
23. Other duties as assigned, including department-wide projects.
24. Perform cross-functional and/or other duties as assigned or requested. For example, assist other departments with completing issue review reports CAPAs, and CRs as it relates to Facilities’ action items to help ensure timely closure.
25. Work in compliance of the Occupational Health & Safety Act and its regulations, reporting hazards, deficiencies and contraventions of the Act in a timely manner.

Qualifications:

1. At minimum, completion of a 3-year college program in engineering (applied science), or any related technical field or equivalent job experience in a biopharmaceutical company or recognized equivalent.
2. At minimum, over 6 years of practical and related experience and/or 2 years of on-the-job training required.
3. Minimum 5 years of experience in a GMP environment at a bio/pharmaceutical CDMO.
4. Minimum 5 years of experience in a compliance, documentation or technical role in a bio/pharmaceutical GMP environment.
5. Understanding of facility and process equipment.
6. Strong English written and oral communication skills.
7. Requires a flexible work schedule.

1. Takes a collaborative approach to working with cross-functional teams, with good multicultural awareness.
2. Demonstrates initiative and the ability to deliver high quality outcomes.
3. Leads by example by proactively identifying problems and areas for improvement.
4. Personable with excellent communication skills.
5. Ability to read and understand technical documents.
6. Diligent and service-minded.
7. Ability to communicate with external parties through email and phone.
8. Excellent organizational skills with an eye for detail.
9. Ability to take direction.
10. Enthusiastic and willing to learn.