IT Audit and Regulatory Compliance Lead

Johnson & Johnson is recruiting for an IT Audit and Regulatory Compliance Lead to be located in Raritan, NJ. Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 125 years. We embrace research and science -- bringing innovative ideas, products and services to advance the health and well-being of people. With $93.8 billion in 2021 sales, Johnson & Johnson is the world's most comprehensive and broadly based manufacturer of health care products, as well as a provider of related services, for the consumer, pharmaceutical, and medical devices markets. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world. Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer. This role provides operational support for the implementation and execution of Johnson & Johnson Technology Services (JJT-TS) and Technology Quality (TQ) compliance programs, including Supplier Audit, Internal Audit and Periodic Reviews of J&J enterprise computerized systems. This position is responsible for end-to-end execution of Audit programs and for providing GxP compliance support to base business and innovation initiatives, including, but not limited to, emerging healthcare technology such as RPA, Digital Surgery, AI/ML, etc. This position supports the Inspection Readiness program for JJT-TS, including Data Center Inspection Readiness and direct support to business segments during Health Authority and other Third-party audits related to technology areas. This position maintains awareness of the external regulatory landscape and supports the Regulatory Standards Program to ensure global regulatory requirements are met, including, integration of new or changing regulations into the Technology Services QMS and operational processes. This individual will report to the Sr. Manager, IT Regulatory Compliance. Role Responsibilities: End-to-End Audit Program Leads end-to-end execution of Technology Regulatory Compliance (TRC) closed loop audits programs: JJT-TS Supplier and Internal Audits Segment GxP System Periodic Review and Software Supplier Audits 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), Software as a Medical Device (SaMD), and Mobile Medical Apps (MMaps), encompassing the entire computerized system lifecycle to assess compliance with appropriate health authority regulations, guidance’s, company procedures and industry standards. Review and assess corrective and preventive action plans and execute audit follow-up activities, including verification of remediation commitments, documentation of results, reporting on follow-up status, and escalation of any identified risk. Maintain an in-depth knowledge of Health Authority regulations which could impact the global portfolio of computerized systems used in Supply Chain, Manufacturing, Laboratory, Commercial and R&D. Prepare audit reports and documents observations and commitments clearly, accurately and timely to enable tracking verification. External Regulatory Outreach and Communications Builds and maintains trusting, collaborative relationships and partnerships with internal and external stakeholders to accomplish business objectives. Maintain awareness of new and emerging technologies, regulatory requirements and enforcement trends related to IT systems, Data Integrity, and Health Teach areas such as SAMD, AI/ML, RPA, etc. Supports the Regulatory Standards program and J&J external advocacy efforts through development and submission of comments to proposed regulations and guidance’s. Ensure awareness of industry standards, trends and best practices in order to strengthen GxP knowledge. Compliance Expertise and Support Leads and/or supports the development and delivery of education and training programs to support the rapid pace of innovation in the areas of Industry 4.0, Quality 4.0, and digital health. 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. Support Health Authority inspection readiness activities. Ensuring technical subject matter expert preparedness on matters related to IT processes, computer system validation, and other technical topics. Provides compliance support to innovation initiatives and key projects. Perform gap assessments between current practices and new regulatory expectations, as communicated via new health authority regulations, guidance, and enforcement trends. Work with Quality partners to establish corrective actions to address any identified gaps. Contributing to the content for writing SOPs, WIs and Policies for compliance programs. Qualifications Minimum of a Bachelor’s Degree is required Minimum of 6 years of professional related experience is required Minimum of 2 years of experience in information systems auditing within Pharmaceutical/Medical Device company or 3 years of direct experience with development, implementation and/or validation of computerized systems within Pharmaceutical/Medical Device company is preferred Advanced auditing skills with demonstrated aptitude for auditing Information Systems and associated processes is preferred Foundational 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 is preferred Intermediate knowledge of IT internal controls, SDLC, and Computer System Validation methodologies is required Ability to analyze and interpret regulatory documents required Demonstrated ability to support complex projects, priorities and multiple tasks required Excellent verbal and written communication skills required Ability to influence, negotiate, inspire trust, and quickly build credibility to enable the achievement of mutual goals. Strong skills in interdependent partnering to facilitate collaboration. Ability to perform work with a high degree of independence and proven experience in driving progress and remaining focused under ambiguous and complex situations. Ambition/desire to learn and upskill on technologies supporting Industry 4.0, Quality 4.0, and digital health Ability to work effectively in a virtual team environment. Expertise in medical device software quality requirements, including standards for medical device software development and risk management preferred. Experience working with Quality Management Systems required Experience interpreting regulations and translating regulatory requirements into practical strategies. Knowledge of process design, development and continual improvement is desired Experience effectively interfacing with global regulatory agencies, e.g., FDA, MHRA, TGA, notified bodies, etc. is preferred CISSP, CISA, ASQ, ISO Lead auditor or other auditor certification preferred. This position will be located in Raritan, NJ and may require up to 15% travel At Johnson & Johnson, we’re on a mission to change the trajectory of health for humanity. That starts by creating the world’s healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional, and financial health of our employees and the ones they love. As such, candidates offered employment must show proof of COVID-19 vaccination or secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families and the communities in which we live and work. For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com. Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Primary Location United States-New Jersey-Raritan-1003 US HIghway 202 Organization Johnson & Johnson Services Inc. (6090) Job Function Info Technology Requisition ID 2206054981W