Company Overview 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. Through our expertise in Cutting-edge Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com. As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.
Key Responsibilities Auditing 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. Ensures the relevant standard procedures, diagnostic tools, and audit plans are fully understood and applied in audit activities. 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. Independently advises and coaches other auditors. Involved with the review and approval of curriculum as applicable. Completes training requirements in a timely manner to ensure inspection readiness at all times.
People Management Able to supervise junior auditors/contractors. Deputizes for Team Lead, as required.
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.
Expertise Actively shares business area and regulatory knowledge/expertise. May act as a primary contact for internal and/or external stakeholders. Conducts Peer review of audit reports, as required. 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.
Qualifications Education: Minimum bachelor’s or equivalent University degree required; Focused degree in a life, natural, or computer science is preferred.
Experience and Skills: Required:



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. Strong teamwork and analytical skills.
Preferred: Experience in leading complex pharmacovigilance audit types e.g., system audits.
Other: Must be fluent in English.
This position requires 25% domestic and international travel.
Required Skills Business Alignment
Coaching
Collaboration
Compliance Management
Continuous Improvement
Fact‑Based Decision Making
Good Manufacturing Practices (GMP)
ISO9001
Process Improvements
Quality Control (QC)
Quality Management Systems (QMS)
Quality Standards
Quality Validation
Regulatory Environment
Standard Operating Procedure (SOP)
Tactical Thinking
Technical Credibility
Pay The anticipated base pay range for this position is : 112,150 CAD - 162,150 CAD
Additional Pay Transparency 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
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. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/.

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📌 Pharmacovigilance Quality Assurance Manager (Ontario)
🏢 6010-Biosense Webster Inc. Legal Entity
📍 Ontario