Pharmacovigilance QA Auditor Specialist

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.

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

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

As a Pharmacovigilance Quality Assurance Auditor Specialist you will be part of a dynamic global team working to enhance quality across the Company through pharmacovigilance audit and business partner collaboration.

Are you interested in joining a team delivering outstanding results to our customers and patients? Apply now for this exciting opportunity!

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 , internal employees contact AskGS to be directed to your accommodation resource.

#LI-Hybrid

Required Skills:

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)).

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

For additional general information on Company benefits, please go to: -