Compliance Lead, US RMPV Compliance (Titusville, NJ)

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:

Product Safety

Job Sub Function:

Pharmacovigilance

Job Category:

People Leader

All Job Posting Locations:

Titusville, New Jersey, United States of America

Job Description:

J&J Innovative Medicine is recruiting for a Compliance Lead, US RMPV Compliance to be located in Titusville, NJ.

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

 

The Compliance Lead, US RMPV Compliance, Associate Director is responsible for leading the US Risk Management & Pharmacovigilance Compliance (US RMPVC) inspection readiness and compliance program within the Johnson & Johnson Innovative Medicine (J&J IM) US Commercial Operating Companies (OpCo) in support of the US Local Safety Officer (LSO) / Pharmacovigilance Officer (PVO).

This role is responsible for the development of robust US RMPVC non-conformance (NC) and CAPA commitments to ensure effective remediation and process improvement are implemented in partnership with Commercial Quality (CQ). The role is primarily focused on Risk Evaluation and Mitigation Strategy (REMS) compliance.

Under the direction of the LSO/PVO in collaboration with CQ, the position leads projects to drive audit and inspection readiness, supporting key improvement initiatives with US RMPVC team members, Subject Matter Experts (SMEs), and cross-functional stakeholders.

Key Responsibilities:

• Support the LSO/PVO oversight of local risk minimization and REMS activities, ensuring compliance with regulations and internal policies and procedures.

• Collaborate with CQ to assess potential PV/REMS non‑conformances and manage NC/CAPA records, ensuring robust documentation and timely completion to support inspection readiness.

• Oversee US RMPVC stakeholder involvement in NC/CAPA development through resolution, and manage CAPA communications and supporting documentation to enable Leadership participation in the CQ CAPA Review Board.

• Participate in the development of metrics to facilitate LSO/PVO oversight of US OpCo, IM Office of the Chief Medical Officer (OCMO), Product Quality Vigilance (PQV) and US RMPVC compliance performance, addressing any trends identified.     

• Support and act as a US RMPVC liaison during audits and/or inspections; supports the activities related to closure of internal and external audit and inspection records.

• Support the development of short-term and long-term audit readiness strategies and proactive practices for US RMPVC including operational process monitoring (“spot checks”) to ensure functional area compliance and documentation inspection readiness.

• Contribute to developing strategic end‑to‑end processes and innovative solutions to mitigate US RMPVC and business compliance risks; lead change across the US OpCo to ensure PV compliance and support the development of procedural documents and training materials.

Qualifications and Experience:

• BA/BS required; MA/MBA/MHA preferred

• 7+ years’ experience in pharmaceutical industry REMS related function.

• Requires knowledge of PV, REMS, global risk‑management regulations, drug development, and post‑marketing obligations, including product quality complaints, with experience in REMS.

• Experienced in auditing, compliance, and navigating complex matrixed environments.

• Strong communicator with excellent writing, presentation, interpersonal, and customer‑service skills; effective at building credibility across all organizational levels.

• Proven leader with coaching ability, skilled in guiding cross‑functional teams, influencing without authority, and driving high‑quality, timely work.

• Strong organizational, problem‑solving, and project management capabilities; able to manage multiple detailed tasks under tight timelines.

• Familiar with J&J systems and tools (e.g., COMET, Salesforce.com); committed to continuous improvement and adapting to evolving business needs

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

Required Skills:

 

 

Preferred Skills:

Developing Others, Global Market, Inclusive Leadership, Leadership, Medicines and Device Development and Regulation, Operations Management, Performance Measurement, Pharmacovigilance, Quality Control (QC), Quality Management Systems (QMS), Regulatory Affairs Management, Report Writing, Safety Investigations, Safety-Oriented, Safety Reporting, Serious Adverse Event Reporting, Team Management

 

 

The anticipated base pay range for this position is :

$137,000.00 - $235,750.00

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)).

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



This position is eligible to participate in the Company’s long-term incentive program.



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