Manager Technology Regulatory Compliance

le contenu du travail

Manager Technology Regulatory Compliance Position Summary 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. Major Duties and Responsibilities Leads and executes internal audits and periodic reviews covering key Johnson and Johnson Technology 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 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 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). 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. Reviews remediation action plans for acceptability and leads audit follow-up activities to verify effectiveness of audit corrective action plans. Regularly provides regulatory compliance expertise and support to ‘Digital Health’ technology (i.e., 3D printing, Robotic Processing Agents, Artificial Intelligence, Robotics, Software as a Medical Device (SAMD), Software in a Medical Device (SiMD), Cybersecurity). Experience in this area is an asset. Participates in gap assessments to new 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 to accomplish business objectives. Applies knowledge of current and emerging regulatory trends to continuously improve audit programs. Supports Health Authority inspection readiness activities and interacts with regulators on matters related to technology processes, computer system validation, and other technical topics. Participates in industry and other professional networks to ensure awareness of industry standards and trends in order to strengthen GxP audit knowledge. Qualifications Required Knowledge, Skills and Abilities A Bachelor’s degree is required. Advanced degree preferred. 5 years of related experience is required. Experience in the pharmaceutical/ medical device/ biotech industry is required. A minimum of 2 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, GAMP5, ISO-9001, ISO-13485, ISO-27001, NIST, etc Medical device regulatory compliance experience is an asset. Excellent written and oral communication skills, including consistent track record to make technical and complex topics clear and easily understood orally and in writing. Supervisory/People Management experience is an asset. 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, inspire, 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 handle 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 experience in driving progress and remaining focused under ambiguous and complex situations. Ability to work effectively in a virtual team environment. This position may require up to 10% domestic and international travel as business demands. Primary Location Belgium-Antwerp-Beerse- Organization Janssen Pharmaceutica N.V. (7555) Job Function Info Technology Requisition ID 2105962514W