Quality Assurance Supervisor

Novum Pharmaceutical Research Services; Toronto; On-site; CAD 80,000 - 110,000; Full time

Job summary

A leading pharmaceutical research firm in Toronto is seeking a Quality Assurance professional to ensure compliance with regulatory requirements and internal standards. Responsibilities include monitoring studies, conducting audits, and writing SOPs. Candidates must have a B.Sc. in a scientific discipline and at least 5 years of experience in the CRO industry. This full-time position offers a salary range of CA$80,000 to CA$110,000.

Qualifications

• Minimum 5 years of experience in clinical research or CRO industries.
• Strong understanding of regulatory requirements.
• Experience with writing SOPs and conducting audits.

Responsibilities

• Monitor studies for compliance with protocols and SOPs.
• Conduct retrospective compliance audits.
• Write and review Standard Operating Procedures.
• Prepare action plans for regulatory inspections.

Skills

Quality Control

Quality Assurance processes

Clinical research

Auditing

Education

B.Sc. degree in a scientific discipline

Job description

Responsible for providing assurance to the Novum Pharmaceutical Research Services (NVM) management team that the facilities, equipment, personnel, methods, practices, records, controls, and services received are in compliance with the Health Canada Regulatory Requirements, NVM Approved standards / procedures, and other applicable regulatory requirements (i.e., US FDA, EMA, OECD principles of GLP). Responsible for overseeing archiving-related activities.

Responsibilities

• Monitor each study to ensure compliance with the facilities, equipment, personnel, methods, practices, records, and controls according to 21 CFR Part 58 and OECD Principles of Good Laboratory Practices.
• Conduct retrospective audits of studies for compliance with Protocol, NVM-Toronto Standards (Policies, SOPs), Health Canada Regulatory requirements (Division 5 Part C), and other applicable regulations (US FDA, EMA).
• Inspect each non-clinical laboratory study at intervals sufficient to assure study integrity.
• Review Deviation Reports, Investigation Reports, and Corrective Actions.
• Write, revise, and review Standard Operating Procedures (SOPs) in line with NVM Standards/Policies, and participate in SOP review cycles. Notify QA Management of all critical and major deviations, observations, or deficiencies.
• Prepare action plans in response to regulatory inspections or client site audits.

Qualifications

• Minimum B.Sc. degree in a scientific discipline or equivalent.
• At least 5 years of experience in clinical research or CRO industries, with a strong understanding of Quality Control and Quality Assurance processes.
• Previous QA/QC experience is preferred.

Additional Information

Seniority level: Mid-Senior level

Employment type: Full-time

Job function: Quality Assurance

Industry: Research Services

Location: Toronto, Ontario, Canada

Salary Range: CA$80,000.00 - CA$110,000.00