Johnson & Johnson Careers
Manager, Technology Regulatory Compliance
Requisition ID: 5240180627
Johnson & Johnson is recruiting for a Manager, Technology Regulatory Compliance to be located in Raritan, NJ or field-based with remote capabilities.
Johnson & Johnson, through its operating companies, 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 and diagnostics markets. We strive to provide scientifically sound, high quality products and services to help heal, cure disease and improve the quality of life.
The Manager, Technology Regulatory Compliance leads and executes risk-based internal audits of Technology related GxP processes and conducts periodic reviews of GxP computerized systems across the Johnson & Johnson family of companies to ensure compliance with global GxP regulations and J&J internal Standards. This manager will lead and conduct audits of suppliers of GxP related software and technology services to assess the quality of products and services and to support a risk based approach to computer system validation and lifecycle management.
In this role, you will provide inspection readiness support, provide strategic and tactical GxP compliance and digital health expertise in order to support business partners to ensure effectiveness of remediation action plans. You will report to the Senior Manager, Technology Regulatory Compliance.
Responsibilities include but are not limited to:
- Leads and executes internal audits and periodic reviews covering key IT GxP related processes, large global portfolio of computerized systems covering Supply Chain, Manufacturing, Laboratory, Commercial and R&D, including ERP systems (e.g., SAP, JDE), Manufacturing Execution Systems (MES), Warehouse Management System (WMS), Laboratory Information Management Systems (e.g., LIMS and Empower), Quality Systems (e.g., CAPA, Non-Conformance, Change Control, etc.) Enterprise Master Data Management (EMDM) and Data Warehousing.
- Leads and executes supplier audits, covering GxP related software and technology service providers, including 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).
- Determines and documents adherence to Johnson & Johnson enterprise standard operating procedures and regulatory requirements and identifies and communicates compliance related issues, including the risk criticality of each issue; the validated status of systems; and the rating/classification of suppliers.
- Communicates compliance gaps, considering big picture risks, and gains business partner commitment to address issues found during audits. Authors audit reports and documents observations and commitments clearly, accurately and timely to enable tracking verification.
- Utilizes expert knowledge of regulations and risk management concepts to ensure compliance with local and global regulations.
- Reviews remediation action plans for acceptability and leads and executes audit follow-up activities to verify effectiveness of audit corrective action plans.
- Regularly provides ‘Digital Health’ (i.e., support for 3D printing, Robotic Processing Agents, Artificial Intelligence, Robotics, Software as a Medical Device (SAMD), Software in a Medical Device (SiMD), etc.) regulatory compliance expertise and support to business partners.
- Supports Health Authority inspection readiness activities ensuring technical subject matter expert preparedness and interacts with regulators on matters related to IT processes, computer system validation, and other technical topics.
- Participates in gap assessments to new or evolving regulatory requirements and guidances.
- Partners with other compliance groups (J&J Regulatory Compliance/ R&D Compliance/ Corporate Internal Audit) as needed on for auditing and remediation activities.
- Builds and maintains trusting, collaborative relationships and partnerships with internal stakeholders to accomplish business objectives.
- Participates in industry and other professional networks to ensure awareness of industry standards, trends and best practices in order to strengthen GxP audit knowledge.
- Identifies potential risks, articulates impact, and gains alignment from business partners to establish proactive risk mitigation strategies.
- Applies knowledge of current and emerging regulatory trends to continuously improve audit programs.
- Serves as a people leader and is responsible for the performance and development for a small team - one direct report to start.
- A minimum of a Bachelor’s degree is required. Advanced degree preferred.
- A minimum of 5 years of related experience is required.
- Experience in the pharmaceutical/ medical device/ biotech industry is required.
- A minimum of 3 or more years leading and executing audits of computerized systems (software and infrastructure) is required.
- Expert knowledge of GxP regulations is required; including Annex 11, 21 CFR Part 11, Part 210, Part 211 and Part 820, and how these apply to Computer Systems.
- A minimum of 1 year of medical device regulatory compliance experience is required.
- A minimum of 1 year of ‘Digital Health’ experience is required (i.e., support for 3D printing, Robotic Processing Agents, Artificial Intelligence, Robotics, Software as a Medical Device (SAMD), Software in a Medical Device (SiMD), etc.)
- Expert knowledge of leading practices including but not limited to; GAMP5, ISO-9001, ISO-27001, NIST, etc.
- Excellent written and oral communication skills, including proven ability to make technical and complex topics clear and easily understood by others.
- Supervisory/People Management experience is required.
- Experience interacting or supporting health authorities and/ or notified bodies during inspections is preferred.
- CISSP, CISA, ASQ, ISO Lead auditor or other auditor certification preferred.
- 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.
- Strong planning and organizational skills and ability to manage complexity and ambiguity.
- Ability to find innovative solutions and to apply risk based thinking to provide pragmatic advice that ensures compliance in a cost-effective way.
- Ability to perform work with a high degree of independence and proven experience in driving progress and remaining focused under ambiguous and complex situations.
- Ability to translate Quality and Compliance regulatory requirements as it relates to IT systems and processes.
- Ability to solve complex and broad-scoped problems and deal with a variety of variables in unique situations.
- Ability to work effectively in a virtual team environment.
- This position may require up to 25% domestic and international travel as business demands.
Do you strive to join an outstanding team that is dynamic and ever-changing? Is career growth and opportunity appealing to you? Apply to this opportunity today.
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
United States-New Jersey-Raritan
North America-United States
Johnson & Johnson Services Inc. (6090)