Lead Technology Compliance

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld 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 Med Tech, 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.

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Legal & Compliance

Enterprise Compliance

Professional

Horsham, Pennsylvania, United States of America, New Brunswick, New Jersey, United States of America, Raritan, New Jersey, United States of America

Johnson & Johnson is currently recruiting for the best talent for a Lead, Technology Compliance to be located in Raritan, NJ, Horsham, PA, New Brunswick, NJ or Beerse, Belgium. Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s):
North America
- Requisition #R-089703 EMEA– Requisition# R-090248 The Lead, ERP & WMS Technology Compliance is responsible for execution and operational support of J&J Technology Quality & Compliance (JJTQ&C) global compliance programs.

• execution of closed loop audit and assessment programs, including Technology Supplier Audit and GxP system Periodic Reviews.
• providing direct support to business segments during global health authority inspections and other third-party audits related to Technology areas.
• compliance metrics analysis and communication of risk themes to drive systemic actions when appropriate.

Additionally, this position assists in the continuous improvement of the compliance programs, including external regulatory outreach to shape emerging regulations in the areas of technology and innovative healthcare solutions. This position reports to the Head, Med Tech & Emerging Compliance.

• Executes closed loop Supplier Audit and GxP System Periodic Review Programs, including conducting independent audits/reviews, providing independent oversight of audit planning, audit and assessment corrective actions, documenting results, reporting on follow-up status, escalating critical issues/risk to senior leadership,
• Plan, organize and execute comprehensive audits of GxP software and/or software technology service providers such as suppliers of infrastructure as a service (IaaS), Platform as a service (PaaS), Software as a Service (SaaS), encompassing the entire computerized system lifecycle to assess compliance with appropriate health authority regulations, guidance, company procedures and industry standards
• Partners with Technology Quality and Business Quality to execute gap assessments between current practices and new regulatory expectations, as communicated via health authority regulations, guidance, and enforcement trends. Works with Quality partners to establish corrective actions to address any identified gaps.
• Leads the resolution of complex situations that arise during execution of closed loop audit and assessment programs, including conflict resolution, articulates risks and impact, negotiates alignment and secures support for remediation actions that reduce risk.

• Maintain awareness of new and emerging technologies and regulatory requirements
• Ensure awareness of industry standards, trends and best practices in order to strengthen GxP knowledge.
• Participates in industry and other professional networks to ensure awareness of industry standards, trends and enforcement actions in order to strengthen compliance programs. Engage with industry groups (e.g., ISPE, Adva Med) to shape the external regulatory environment.

• Ensure timely and effective support is provided to J&J Operating Companies globally, including working with inspection site leadership to understand Enterprise Quality related inspection requests and preparing technical subject matter experts to speak with investigators.
• Engages directly with health authority inspectors from regulatory agencies and assists/accompanies technical subject matter experts to engage with regulators as needed.
• Provides compliance input and final review of formal responses to health authority observations related to Enterprise Quality

• Provides compliance subject matter expertise and support to Technology Quality and sector Business Partners related to GxP processes in the end-to-end technology areas.
• Partners with stakeholders to assess, develop and implement solutions that enable…