Lead, Technology Compliance

Company: Disability Solutions
Location: Raritan
Posted on: November 1, 2024

Job Description:

Johnson & Johnson Services Inc., a member of Johnson & Johnson's Family of Companies, is seeking a highly motivated and experienced Lead, Technology Compliance individual to join our exceptional team! While the primary location of this role is Raritan, NJ individuals can also be located at our Horsham, PA; Cincinnati, OH or Tampa, FL location.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 https://www.jnj.com/.For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world's most pressing healthcare challenges.We know that the success of our business - and our ability to deliver meaningful solutions - depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential.At Johnson & Johnson, we all belong.This position is responsible for supporting audit and assessment corrective actions as part of closed loop 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!In this role, you will play a crucial part in ensuring the flawless compliance of our technology systems and processes. As a world-class company dedicated to improving the health and well-being of people around the globe, we are looking for someone who has extensive experience in Quality and Regulatory Compliance in a regulated healthcare environment. If you are ambitious, proven in your field, and thrive in a collaborative environment, this is the opportunity for you!Key Responsibilities:

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• Leads and performs closed loop periodic reviews of J&J Segment (Innovative Medicine, Med Tech, and Enterprise) GxP computerized systems that are supported by 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).
• Prepares audit reports and document observations and commitments clearly and accurately.
• Ensures timely and effective support is provided to J&J Operating Companies globally, including working with inspection site leadership to understand 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.\r\r

Keywords: Disability Solutions, Hoboken , Lead, Technology Compliance, IT / Software / Systems , Raritan, New Jersey