Pharmacovigilance QA Auditor Specialist

Biopharma Careers; Raritan (NJ); On-site; USD 79,000 - 128,000; Full time

Job summary

Johnson & Johnson seeks a Pharmacovigilance QA Auditor Specialist to lead PV audits in a fast-paced, quality-driven environment. The role covers planning, conducting, and reporting audits, with a focus on GxP and non-regulated areas, and collaboration with regulatory teams.

The candidate will travel up to 25% and support inspections, training, and process improvements. A minimum of 4 years in PV and strong communication skills are required.

Qualifications

• A minimum of 4 years of relevant work experience in Pharmacovigilance.
• Strong project management and coordination skills.
• Excellent verbal and written communication and presentation skills.
• Strong data analysis, attention to detail, and critical thinking.
• Proficiency with Microsoft Office (Outlook, PowerPoint, Excel, Word).
• Travel up to 25% domestically and internationally.

Responsibilities

• Leads the planning, conduct and reporting of routine PV internal and external audits
• Supports audits, data, internal facilities and processes in GxP/non-regulated areas
• Supports regulatory inspections in various supporting roles.
• Participates in projects or serves on teams, as assigned by supervisor.
• Provides consultation to business partners on routine tasks with occasional supervision.
• Collaborates with business partners when contacted for compliance inquiries and seeks advice on non-routine and more complex issues to ensure a departmental unified position.
• May assist in the preparation of training material if requested.

Skills

Agile Internal Audit

Analytical Reasoning

Audit and Compliance Trends

Audit Reporting

Business Behavior

Compliance Management

Compliance Policies

Compliance Risk

Critical Thinking

Detail-Oriented

Problem Solving

Quality Control

Quality Standards

Regulatory Environment

Education

Bachelor's degree (required)

Life sciences / natural sciences / computer science preferred

Tools

Microsoft Office: Outlook, PowerPoint, Excel, Word

Job description

Job Function

Quality

Job Sub Function

Quality & Compliance Audit

Job Category

Professional

All Job Posting Locations

• Horsham, Pennsylvania, United States of America
• Raritan, New Jersey, United States of America
• Titusville, New Jersey, United States of America

Job Description

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

We are searching for the best talent for Pharmacovigilance QA Auditor Specialist to be located at Raritan, NJ; Titusville, NJ or Horsham, PA.

Key Responsibilities

• Leads the planning, conduct and reporting of routine PV internal and external audits
• Supports audits, data, internal facilities and processes in GxP/non-regulated areas
• Supports regulatory inspections in various supporting roles.
• Participates in projects or serves on teams, as assigned by supervisor.
• Provides consultation to business partners on routine tasks with occasional supervision.
• Collaborates with business partners when contacted for compliance inquiries and seeks advice on non-routine and more complex issues to ensure a departmental unified position.
• May assist in the preparation of training material if requested.

Qualifications

Education:

Minimum Bachelor’s degree is required; Focused degree in a life, natural, or computer science is preferred.

Experience and Skills:

Required:

• A minimum of 4 years of relevant work experience in Pharmacovigilance
• Strong project management experience
• Strong verbal and written skills, including presentation skills
• Strong teamwork and collaboration skills
• Strong in data analysis, critical thinking and attention to details
• Experience working with Microsoft Office tools (Outlook, Power Point, Excel, Word)

Preferred:

• Broad understanding of auditing process and landscape
• Audit experience in various audit types

Other:

• This position requires 25% of domestic and/or international travel

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.

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.

Required/Preferred Skills

• Agile Internal Audit
• Analytical Reasoning
• Audit and Compliance Trends
• Audit Reporting
• Business Behavior
• Compliance Management
• Compliance Policies
• Compliance Risk
• Critical Thinking
• Detail-Oriented
• Problem Solving
• Quality Control (QC)
• Quality Standards
• Regulatory Environment

The anticipated base pay range for this position is :

$79,000.00 - $127,650.00

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)).

• 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

For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits