Pharmacovigilance QA Manager - Global Audits & Compliance

Johnson & Johnson Innovative Medicine; Toronto; On-site; CAD 112,000 - 162,000; Full time

Job summary

Johnson & Johnson Innovative Medicine in Toronto, Canada is seeking a Pharmacovigilance Quality Assurance Manager to oversee audit programs, regulatory compliance, and QA activities across R&D operations. You will lead audits, support regulatory inspections, and mentor junior staff while partnering with cross-functional teams.

The role requires 6+ years in a GxP regulated environment with 3 years in PV auditing, strong leadership and communication skills, and willingness to travel up to 25%.

Qualifications

• Minimum bachelor’s or equivalent University degree required; Focused degree in a life, natural, or computer science is preferred
• A minimum of 6 years of relevant work experience in a GxP regulated industry including 3 years in pharmacovigilance auditing
• Strong project management experience
• Strong verbal and written skills, including presentation skills
• Must be fluent in English

Responsibilities

• Independently leads planning, conduct, and reporting of audits/assessments in GxP/non-regulated areas to assure adherence to corporate policies and regulatory requirements
• Supports other auditors in planning, conduct and reporting of audits
• Ensures standard procedures and audit plans are understood and applied in audit activities
• Supports the CAPA process following the audit as needed
• Encourages and supports others to properly manage and document risk-based audit planning

Skills

Auditing

Pharmacovigilance

Project management

Regulatory knowledge

English communication

Education

Bachelor's degree in life, natural or computer science

Job description

Johnson & Johnson Innovative Medicine in Toronto, Canada is seeking a Pharmacovigilance Quality Assurance Manager to oversee audit programs, regulatory compliance, and QA activities across R&D operations. You will lead audits, support regulatory inspections, and mentor junior staff while partnering with cross-functional teams.

The role requires 6+ years in a GxP regulated environment with 3 years in PV auditing, strong leadership and communication skills, and willingness to travel up to 25%.