Pharmacovigilance Quality Assurance Manager

Location: Raritan, New Jersey, United States of America; hybrid role with 25% domestic and international travel.

Salary: $102,000–$177,100 per year

Company

Johnson & Johnson MedTech develops healthcare solutions and medicines through its Innovative Medicine and MedTech businesses.

What you will do

• Lead the planning, execution, and reporting of routine and non-routine R&D Quality Assurance audits, assessments, and inspections.
• Conduct complex audits involving due diligence, investigations, cross-functional activities, systems, and service providers.
• Support audit-related CAPA activities and risk-based audit planning.
• Participate in regulatory inspections, including hosting and backroom leadership.
• Train, coach, and supervise junior auditors and contractors; deputize for the Team Lead when required.
• Lead quality initiatives and advise business partners on compliance processes and regulatory requirements.

Requirements

• Bachelor’s degree or equivalent university degree required; a degree in life, natural, or computer science is preferred.
• At least 6 years of relevant experience in a GxP-regulated industry, including 3 years in pharmacovigilance auditing.
• Strong project management, analytical, teamwork, presentation, verbal, and written communication skills.
• Fluent English required.
• Ability to work in a hybrid role based in Raritan, New Jersey, United States of America, with 25% domestic and international travel.

Nice to have

• Experience leading complex pharmacovigilance audits, including system audits.
• Experience with GMP, ISO 9001, quality management systems, quality validation, SOPs, and continuous improvement.

Culture & Benefits

• Inclusive work environment focused on diversity, dignity, and equal opportunity.
• Participation in pension, 401(k), and long-term incentive programs.
• Vacation, sick time, holiday pay, personal and family time, parental leave, bereavement leave, caregiver leave, volunteer leave, and military spouse time off.
• Support for an inclusive interview process and reasonable accommodations.