Lead, Technology Compliance - Raritan, United States - Johnson & Johnson

Johnson & Johnson Raritan, United States

2 weeks ago

Description

Johnson & Johnson Services Inc., a member of Johnson & Johnson's Family of Companies, is recruiting for a Lead, Technology Compliance, located in Raritan, NJ

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 .

The Lead, Technology Compliance is responsible for providing operational support for the execution of Enterprise Quality Compliance Programs.

This position is responsible for supporting audit and assessment corrective actions as part of closed loop audit and assessment programs, including Technology Supplier Audit and GxP System Periodic Review. This role is also responsible for providing direct support to business segments during Health Authority and other Third-Party audits related to Technology areas; and compliance metrics analysis and communication of risk themes to drive systemic actions when appropriate. 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

Key Responsibilities

Leads and performs closed loop periodic reviews of J&J Segment (Innovative Medicine, Med Tech and Enterprise) GxP computerized systems that are supported by Enterprise Quality including a large global portfolio of computerized systems covering Manufacturing and Laboratory.
Leads and performs closed loop supplier audits, covering GxP related software and service providers, including suppliers of infrastructure as a service (IaaS), Platform as a service (PaaS), Software as a Service (SaaS).
Assists in providing independent oversight of audit and assessment corrective actions, documenting results, reporting on follow-up status, raising any identified risk, and assisting with the continuous improvement of the follow-up program.
Ensures 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 domain experts to speak with investigators.
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.
Maintain awareness of new and emerging technologies and regulatory requirements.

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