Compliance Lead, US RMPV Compliance (Titusville, NJ)

Johnson & Johnson Innovative Medicine•Hopewell Township, NJ

1d•Onsite

About The Position

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

Requirements

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

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.

Benefits

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