At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Quality Quality Assurance All Job Posting Locations: We are searching for the best talent for Pharmacovigilance Quality Assurance Manager Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission. Independently leads the planning, conduct, reporting of R&D; Quality QA routine and non-routine audits/assessments/inspections of activities, data, internal facilities and processes in GxP/non-regulated to assure adherence to corporate policies, internal standards/requirements and compliance with applicable regulatory requirements.

Non-routine audits include Due Diligence, for cause audits, cross-functional, complex/sensitive system/service provider audits as defined by the scope. Manages complex or business critical audits/issues in a supporting or leading role. Supports other auditors in planning, conduct and reporting of audits.

Supports the CAPA process following the audit as needed. Encourages and supports others to properly manage and document the risk-based approach in the audit planning and conduct Inspection Support ~ May participate in regulatory inspections in a leadership role (e.g. host, backroom lead) Training & Development Identifies training needs.

Supports





Development and provides training. Completes training requirements in a timely manner to ensure inspection readiness at all times.

People Management

Able to supervise junior auditors/contractors Project Management ~ Leads initiatives and actively participates in key projects across the organization or company. Interacts with key stakeholders and can influence and effectively drive projects to completion. Actively shares business area and regulatory knowledge/expertise.

Independently provides consultation and advice to Business Partners on quality and compliance processes/procedures. Interprets and applies regulations/policies to unique and/or complex issues, when required. 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 Solid project management experience Experience in leading complex pharmacovigilance audit types e.g., Must be fluent in English.

This position requires 25% domestic and international travel. #Business Alignment, Coaching, Collaboration, Compliance Management, Continuous Improvement, Fact-Based Decision Making, Good Manufacturing Practices (GMP), ISO 9001, Process Improvements, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Quality Validation, Regulatory Environment, Standard Operating Procedure (SOP), Tactical Thinking, Technical Credibility 112,150 CAD - 162,150 CAD As applicable for the role - Under current guidelines, this position is eligible for a discretionary performance bonus.

- The Company uses Artificial Intelligence in its assessment of applicants.
- This job posting is for an existing position. #

📌 Pharmacovigilance Quality Assurance Manager (Toronto)
🏢 Johnson u0026 Johnson
📍 Toronto