Lead Technology Compliance

Lead, Technology Compliance

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.

The Lead, ERP & WMS Technology Compliance is responsible for execution and operational support of J&J Technology Quality & Compliance (JJTQ&C) global compliance programs.

Key Responsibilities:

• 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.

Tasks/Duties/Responsibilities:

• 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 compliant innovation. Identifies potential risks, articulates impact, and works with business partners to establish proactive risk mitigation strategies.
• When applicable, lead the development and delivery of education and training on compliance requirements, procedures and controls to key stakeholders

Perform other work-related duties as assigned.

• Ensures timely reports of status, metrics and time sheets as required by the Technology Quality & Compliance organization
• Ensures timely completion of assigned training and expense reports.
• Supports JJRC enterprise initiatives, including execution of JJRC independent audit program, projects, and special assignments.
• Proactively sense for opportunities and actively participate in compliance program development from the outset

Qualifications:

Education:

A minimum of a Bachelor's or equivalent University degree is required.

Required

Knowledge, Skills and Abilities:

• 3+ years of progressive experience in managing all aspects of Quality and Regulatory Compliance in an international, global context, in a regulated healthcare environment.
• Expert knowledge of Quality System regulations, ISO, ICH, PIC/S, and cGMP regulations, including Annex 11, 21 CFR Part 11, Part 210, Part 211 and Part 820, and how these apply to Computer Systems and software medical devices.
• Auditor experience in a regulated…