Compliance Lead, US RMPV Compliance (Titusville, NJ)
Johnson & Johnson, Titusville, FL, United States
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
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
Compensation
$137,000.00 - $235,750.00
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
Long‑Term Incentive Program
This position is eligible to participate in the Company’s long‑term incentive program.
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 period 10 days
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year
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.
#J-18808-Ljbffr
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
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
Compensation
$137,000.00 - $235,750.00
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
Long‑Term Incentive Program
This position is eligible to participate in the Company’s long‑term incentive program.
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 period 10 days
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year
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.
#J-18808-Ljbffr