Compliance Lead, US RMPV Compliance (Titusville, NJ)

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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 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 nonconformances 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 endtoend 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 riskmanagement regulations drug development and postmarketing 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 customerservice skills; effective at building credibility across all organizational levels.

• Proven leader with coaching ability skilled in guiding crossfunctional teams influencing without authority and driving highquality timely work.

• Strong organizational problemsolving and project management capabilities; able to manage multiple detailed tasks under tight timelines.

• Familiar with J&J systems and tools (e.g. COMET ); 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 and internal employees contact AskGS to be directed to your accommodation resource.

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