Pharmacovigilance Quality Assurance Manager
Skills
About the role
This manager-level role leads auditing, inspection support, and quality governance for drug safety operations at Johnson & Johnson's Innovative Medicine division in Raritan, New Jersey. You'll conduct routine and non-routine audits of GxP-regulated activities, manage complex compliance issues, support regulatory inspections, and develop quality assurance staff in an on-site environment.
What you’ll do
- Independently lead the planning, conduct, and reporting of routine and non-routine quality audits and assessments
- Conduct audits of R&D activities, data, internal facilities, and processes to ensure regulatory compliance
- Manage complex and business-critical audits, including due diligence and for-cause audits
- Support other auditors in planning, conducting, and reporting audit activities
- Participate in regulatory inspections in a leadership role
- Identify training needs and provide coaching to other auditors
- Supervise junior auditors and contractors
- Deputize for team leadership as required
- Lead initiatives and participate in key projects across the organization
- Share business area and regulatory expertise with internal and external stakeholders
- Provide consultation on quality and compliance processes
What they’re looking for
- Minimum bachelor's degree or equivalent university degree
- Minimum 6 years of relevant work experience in a GxP regulated industry
- Minimum 3 years of experience in pharmacovigilance auditing
- Strong project management experience
- Strong verbal and written skills, including presentation ability
- Strong teamwork and analytical skills
- Fluent in English
Nice to have
- Experience leading complex pharmacovigilance audit types such as system audits
- Focused degree in a life, natural, or computer science
What’s on offer
- Salary: $102,000 to $177,100 per year
- Consolidated retirement plan (pension)
- 401(k) savings plan
- Long-term incentive program
- Vacation: 120 hours per calendar year
- Sick time: 40-56 hours per calendar year depending on state
- Holiday pay: 13 days per calendar year
- Work, Personal and Family time: up to 40 hours per calendar year
- Parental leave: 480 hours within one year of birth/adoption
- Bereavement leave: 240 hours for immediate family, 40 hours for extended family
- Caregiver leave: 80 hours in 52-week rolling period
- Volunteer leave: 32 hours per calendar year
Questions about this role
What is the salary?
$102,000 to $177,100 per year
Where is this role located?
This is an on-site role in Raritan, New Jersey, United States
What experience is required?
A minimum of 6 years of relevant work experience in a GxP regulated industry, including 3 years in pharmacovigilance auditing
Do I need a degree?
Yes, a bachelor's degree or equivalent university degree is required
Is travel required?
Yes, this position requires 25% domestic and international travel
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