Computer System Validation Lead
Johnson & Johnson is recruiting for a Computer System Validation Lead to be located in New Jersey.
Johnson & Johnson Family of Companies, caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for 125 years. We embrace research and science -- bringing innovative ideas, products and services to advance the health and well-being of people. 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.
With $74.3 billion in 2014 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 and diagnostics markets. The more than 250 Johnson & Johnson operating companies employ approximately 119,000 people in 60 countries throughout the world.
You, the Computer System Validation Lead will:
- Be responsible for reviewing and approving validation deliverables of GxP regulated computerized systems to ensure full compliance with Health Authority regulatory requirements and adherence to company policies and procedures by supporting computer validation projects and base business support teams.
- Support internal and external Health Authority regulatory audits, ensuring a high degree of Inspection Readiness for Systems in the CSV portfolio with the purpose of minimizing the risk of inspection observations to Business systems/infrastructure within CSV responsibility.
- Be responsible for the approval of SDLC validation documentation deliverables, such as but not limited to Compliance Plans, User Requirements, User Acceptance Tests, Traceability Matrix, and the Compliance Report, including the approval to release system implementation and/or changes for production use
- Work collaboratively with project teams, providing CSV guidance and support to project and/or base business support teams in the resolution of validation documentation corrections and/or test defects
- Proactively monitor systems and processes to ensure compliance with standard operating procedures, audit compliance and industry best practices moving the organization towards a positive risk management posture
- Build and maintain trusting, collaborative relationships and partnerships with internal and external stakeholders which help accomplish key business objectives, and helps others to do the same
- A Bachelor's degree and a minimum of 6-8 years of progressive experience in the pharmaceutical/medical device/biotech industry, with direct experience in Computerized System Validation activities is required.
- A degree in Computer Science, Information Systems, Business Administration or other related field is preferred.
- Strong QA analyst skills with experience in Computerized System validation in GxP environments in the pharmaceutical/medical device/biotech are required.
- Expert organizational skills are required.
- The ability to make decisions by seeking out and maintaining trusting and collaborative relationships to meet business needs and demands is required.
- Thorough knowledge of cGMP regulations related to CSV, including 21 CFR Part 11, Part 210, Part 211 and Part 820 is required.
- Working knowledge of Global regulations like Annex 11, SOX, ISO is preferred.
- Working knowledge of PMO, SDLC, GAMP 5, and ITIL frameworks is preferred.
- The ability to perform work with a high degree of independence in terms of self-management of a large variety of tasks and initiatives regarding Quality is required.
- Superior written and oral communication and excellent Microsoft Office skills are required.
- This position will be located in New Jersey and may require up to 10% domestic and/or international travel.
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-New Jersey
Johnson & Johnson Services Inc. (6090)
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