New · posted Nov 13
Johnson & Johnson · Pharmaceuticals
Pharmacovigilance Quality Assurance Manager
- Raritan, NJ
- Hybrid
- Full-time
- Manager
The role
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 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.
Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s):
Brazil R-110867, Canada R-110868, United States of America R-096642
Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.
Other
- Must be fluent in English.
- This position requires 25% domestic and international travel.
Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers. Internal employees contact AskGS to be directed to your accommodation resource.
If you are under 18 years of age you (the candidate) may need to obtain the necessary working papers or other documentation required by state law to start the assignment, as well as get a parent’s consent for the background check.
We are searching for the best talent for Pharmacovigilance Quality Assurance Manager.
What you need
Education
- Minimum bachelor’s or equivalent University degree required; Focused degree in a life, natural, or computer science is preferred
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
Preferrednice to have
- Experience in leading complex pharmacovigilance audit types e.g., system audits
Preferred Skillsnice to have
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
What you'll do
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.
Pay and benefits
$105,000 – $181,700 a year
Employer providedThe anticipated base pay range for this position is
$105,000.00 - $181,700.00
Pension and 401(k) savings plan
Vacation (120 hours per year)
Sick time
13days
Holiday pay (13 days per year)
Parental leave (480 hours)
Bereavement, caregiver and volunteer leave
Where you'll work
Raritan, NJHybridOpen in Maps (opens in a new tab)
More jobs in Raritan, NJWorking conditions
Job Function
Quality
Job Sub Function
Quality Assurance
Job Category
Professional
All Job Posting Locations
Raritan, New Jersey, United States of America
From the posting
About Johnson & Johnson
About Innovative Medicine
Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.
Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.
Learn more at https://www.jnj.com/innovative-medicine
Equal opportunity, accessibility and legal noticesJohnson & Johnson's statements, word for word
Additional Description for Pay Transparency
Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:
Vacation –120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
Holiday pay, including Floating Holidays –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 the birth/adoption/foster care of a child
Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave – 80 hours in a 52-week rolling period10 days
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year
The compensation and benefits information set forth in this posting applies to candidates hired in the United States.
Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.
For additional general information on Company benefits, please go to: https://www.careers.jnj.com/employee-benefits
Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Job intelligence
The context around this role
Live data · November 13, 2026
Salary intelligence
How the pay compares
This roleEmployer provided
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $105,000 | — | $181,700 |
This role: Johnson & Johnson's own published range.
Career trajectory
Where this role sits in Quality Auditing
The general path across 25 open Quality Auditing roles on Regulatory Jobs, with the titles they carry most. Not Johnson & Johnson's own promotion track.
Career resources on Quality Auditing
Skills DNA
What this role leans on
How many of the posting's 33 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- GMP and compliance15
- Collaboration and leadership9
- Documentation and SOPs6
- Lab testing and methods1
- Investigations and CAPA1
- Validation and qualification1
- Regulatory submissions1
- Quality systems and risk1
- Data and digital systems1
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Quality Auditing work in pharmaceuticals, led by the two this posting names, each linked to the agency or standards body that publishes it.
- FDA21 CFR Parts 210 and 211(official source, opens in a new tab)FDA current good manufacturing practice for finished pharmaceuticalsNamed in the posting
- ISOISO 9001(official source, opens in a new tab)Quality management systems requirementsNamed in the posting
- ISOISO 19011(official source, opens in a new tab)Guidelines for auditing management systems
- FDAFDA Investigations Operations Manual(official source, opens in a new tab)How FDA investigators plan and conduct inspections
- EUEU GMP (EudraLex Volume 4)(official source, opens in a new tab)The EU's good manufacturing practice rules, including Annex 1 sterile and Annex 15 validation
- ICHICH Q10(official source, opens in a new tab)The pharmaceutical quality system across the product lifecycle
- ANVISABrazil ANVISA(official source, opens in a new tab)Brazil's Health Regulatory Agency
- FDA21 CFR Part 11(official source, opens in a new tab)FDA rules for electronic records and electronic signatures
- FDAFDA data integrity guidance(official source, opens in a new tab)Data Integrity and Compliance With Drug CGMP: Questions and Answers
- ICHICH Q7(official source, opens in a new tab)Good manufacturing practice for active pharmaceutical ingredients
- FDAFDA quality agreements guidance(official source, opens in a new tab)Contract Manufacturing Arrangements for Drugs: Quality Agreements
- PIC/SPIC/S(official source, opens in a new tab)The Pharmaceutical Inspection Co-operation Scheme and its GMP guide
- ICHICH E6(R3) good clinical practice(official source, opens in a new tab)The international standard for the design, conduct and reporting of clinical trials
- FDA21 CFR Part 58 (GLP)(official source, opens in a new tab)Good laboratory practice for nonclinical laboratory studies
- FDAFDA Bioresearch Monitoring (BIMO)(official source, opens in a new tab)FDA inspections of clinical investigators, sponsors, IRBs and GLP labs
- ICHICH Q9(R1)(official source, opens in a new tab)Quality risk management
Company hiring pulse
Johnson & Johnson on Regulatory Jobs
- 37
- Open roles
- 37
- Distinct roles
- 17
- Locations
By discipline
- Quality23 62%
- Clinical8 22%
- Regulatory6 16%
By level
- Manager14 38%
- Senior & Principal12 32%
- Director6 16%
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Pharmacovigilance Quality Assurance Manager at Johnson & Johnson
Applications close November 20. $105K–$182K a year, employer provided.