Lead, Regulatory Compliance at Johnson & Johnson
Lead, Technology Regulatory Compliance
Multiple Locations: Raritan, New Jersey; United States
Functions: IT Compliance
Requisition ID: 6476190731
Johnson & Johnson is recruiting for a Lead, Technology Regulatory Compliance to be located in Raritan, NJ or field-based with remote capabilities.
Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 130 years. We embrace research and science — bringing innovative ideas, products and services to advance the health and well-being of people.
With $81.6 billion in 2018 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. There are more than 250 Johnson & Johnson operating companies employing over 125,000 people and with products touching the lives of over a billion people every day, throughout the world. If you have the talent and desire to touch the world, Johnson & Johnson has the career opportunities to help make it happen.
The Lead, Technology Regulatory Compliance provides operational support for the implementation, conduct and oversight of the Technology Regulatory Compliance (TRC) and Quality Computer System Validation (QCSV) internal audit program and the Periodic Reviews of computer systems. This includes the Risk Based approach to conduct audits of IT related GxP processes and periodic review of GxP computerized systems across the Johnson & Johnson family of companies to ensure compliance with global GxP regulations and J&J internal Standards.
This individual will also support conduct, execution and reporting for 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. This individual will report to the Manager, Technology Regulatory Compliance.
- Provide Regulatory Compliance support to the Johnson & Johnson (J&J) family of companies as well as J&J IT partners.
- Provide operational support for the execution, conduct and reporting of internal audits and periodic reviews covering key IT internal GxP systems. The scope of internal IT systems will include 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.
- Provide operational support for the execution, conduct and reporting of supplier audits. The scope will include 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).
- Provide on-going support for the global IT related regulatory inspections
- Support inspection readiness activities for internal and external audits/inspections
- Maintain awareness of new and emerging technologies and regulatory requirements
- Partner with stakeholders to assess, develop and implement solutions that enable compliant innovation.
- Partner with Enterprise Regulatory Outreach (ERO) on IT related topics to support outreach and awareness activities.
- Support JJRC enterprise initiatives by participating on working teams or acting as subject matter expert on special assignments as needed.
- Assist with the timely reporting of status and metrics as required by the Technology Regulatory Compliance organization.
- Ensure timely completion of assigned training.
- A minimum of a bachelor’s degree is required. Preferably in one of the following areas; Computer Science, Mathematics, Information Technology, Engineering.
- A minimum of 2 years of experience in IT, GxP Compliance and/or QA in a regulated industry is required.
- A minimum of 1 year of auditing experience in a regulated healthcare industry is required.
- A minimum of 2 years of experience with FDA and global regulatory requirements (e.g. Annex 11, 21 CFR Part11, Part 820 etc.) for Computer System Validation, Electronic Records and Signatures, and Quality System Regulations is required.
- General awareness of ‘Digital Health’ (i.e., 3D printing, Robotic Processing Automation, Artificial Intelligence, Robotics, Software as a Medical Device (SAMD), Software in a Medical Device (SiMD), etc.) is required.
- Experience participating in global virtual teams is required.
- Demonstrated experience in drafting compliance related artifacts is required.
- Experience supporting health authorities and/or notified body inspections is preferred.
- CISA, CQA or other auditor certification preferred.
- Demonstrated ability to support complex projects, priorities and multiple tasks as assigned is required.
- Knowledge of process design, development and continual improvement is preferred.
- Excellent verbal and written communication skills are required.
- Ability to influence, negotiate, inspire trust, and quickly build credibility to enable the achievement of mutual goals is required.
- Ability to perform work with a high degree of independence and proven experience in driving progress and remaining focused under ambiguous and complex situations is required.
- This position is to be located in Raritan, NJ or field-based with remote capabilities and may require up to 25% travel.
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.
United States-New Jersey-Raritan-
North America-United States
Johnson & Johnson Services Inc. (6090)
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