Senior Manager, Cybersecurity Quality and Data Integrity - Raritan New Jersey

Company: Disability Solutions
Location: Raritan, New Jersey
Posted On: 04/21/2024

Johnson & Johnson Services Inc., a member of the Johnson & Johnson Family of Companies, is recruiting for a Senior Manager, Cybersecurity Quality and Data Integrity. The primary and preferred location for this position is Raritan, NJ. (Consideration may be given for candidates located in New Brunswick, NJ, Raynham, MA, Irvine, CA, or Horsham, PA.) 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/. Technology Quality and Compliance (TQ&C) manages the Quality and Compliance strategy for IT systems including applications, infrastructure and digital health solutions for J&J. TQ&C is the Subject Matter Expert (SME) for validation/qualification of both applications and infrastructure in accordance with J&J's Systems Development Life Cycle (SDLC) and Computer System Validation (CSV) Framework, assuring compliance across the enterprise with applicable global regulations, advising on quality matters, and assisting with closing compliance gaps related to audits and inspections. The Senior Manager of Cybersecurity Quality & Data Integrity is responsible for designing and implementing fit-for-purpose quality and compliance strategies and programs in the specialized technical areas of regulated product (Medical Device) Cybersecurity and GxP Data Integrity. This position will serve as the quality partner to J&J Information Security Risk Management. This leader provides quality systems oversight of medical device and non-medical device cybersecurity, as well as security controls supporting data integrity, and collaborates with key senior business partners within the Information Security Risk Management (ISRM) Function and across J&J MedTech and J&J Innovative Medicine Quality organizations globally to sustain risk management and strong compliance posture in these critical regulatory areas. As the Quality Subject Matter Expert for Cybersecurity and GxP Data Integrity, this individual provides leadership oversight and guides project and security teams through the QMS requirements associated with cybersecurity including, but not limited to, design, threat modeling, security testing, and vulnerability monitoring. This position will partner with Information Security Risk Management, JJT-Technology Services, Technology Quality, and Business Sectors to ensure that J&J quality standards and global regulatory requirements are met and will support integration of new or changing regulatory requirements into the JJT-TS QMS. Key Responsibilities:

• Provides quality systems oversight of medical device and non-medical device cybersecurity, as well as security controls supporting data integrity, and collaborates with key senior business partners within the Information Security Risk Management (ISRM) Function and across J&J MedTech and J&J Innovative Medicine Quality organizations globally to sustain risk management and strong compliance posture in these regulated areas.
• Understanding and interpreting global regulatory expectations and providing direction and guidance related to pre and post-market cybersecurity requirements and GxP data integrity, including emerging associated frameworks (e.g., NIST CSF and ISO 27000 family).
• Maintaining knowledge of strategic product and non-product cybersecurity initiatives and innovation programs across J&J globally and serving in a quality strategy advisory capacity in the development of compliant pathways that meet regulatory requirements.
• Guide and train project teams to ensure security and data integrity requirements are understood and implemented, including leading inspection readiness related to these technologies.
• Support incident management, root cause investigations, CAPA (Corrective Action Preventive Action), and audit/inspection observation response and action plans.
• Guides and train project teams to ensure security and data integrity requirements are understood and implemented, including leading inspection readiness related to these technologies.
• Engages directly with health authority agencies during inspections.
• Supports other JJT-TS Quality Management System related processes and duties as needed.
• Mentors talent and helps them grow in their careers. More...

      

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