Johnson & Johnson is currently recruiting for a Lead Computer System Validation, North America (New Consumer Health Company). This position may be located in Lititz, PA; Fort Washington, PA; or Skillman, NJ.
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With $82.1 billion in 2020 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.
If you have the talent and desire to touch the world, Johnson & Johnson has the career opportunities to help make it happen. Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer. Johnson & Johnson is the world's most comprehensive and broadly-based healthcare Company, touching the lives of nearly a billion people every day. Our Family of Companies throughout the world compete in consumer, pharmaceutical and medical devices & diagnostics markets and have the skills and resources to tackle the world's most pressing health issues.
Johnson & Johnson announced plans to separate our Consumer Health business to create a new publicly traded company. The process of the planned separation is anticipated to be completed within 24 months, and it will be subject to legal requirements including consultation with works councils and other employee representative bodies, as required, and other customary conditions and approvals.
It is anticipated that, following conclusion of the transaction, this position may be conveyed with New Consumer Health. In that case, details of any planned changes would be provided to the successful candidate by New Consumer Health at an appropriate time and would be subject to any necessary consultation processes.
Technology Quality and Compliance (TQ&C) manages the quality and compliance strategy for technology systems including applications, infrastructure, and digital health solutions. TQ&C is the Subject Matter Expert (SME) for validation/qualification of both applications and infrastructure in accordance with the company’s Systems Development Life Cycle (SDLC) and Computer System Validation (CSV) Framework, assuring compliance across the enterprise with applicable global regulations, advising on quality matters, and assisting with addressing compliance gaps related to audits and inspections.
The Lead CSV NA is responsible for the building and execution of quality into enterprise-wide systems, tools, services, and infrastructure through the end-to-end lifecycle (design, develop, implement, maintain, and retire).
Roles and Responsibilities:
Engaging with technology team members ensuring early involvement of TQ&C in the design and development of applications and infrastructure, building quality into the work product, and controls within the application/solution while leveraging automation whenever feasible
Ensuring company quality standards and regulatory requirements are met for the systems under the scope of responsibility
Planning, executing, coordinating, and maintaining the validation activities for the systems within their scope, including approval of SDLC validation documentation, release system implementation, and/or changes for production use while providing computerized systems validation guidance and support to support team members in the execution of system base business activities, enhancements, and small projects
Reviewing and approving SOPs and WIs related to the systems within their scope and assisting with incident management/CAPA (Corrective and Preventative Action) and NCs for systems supported
Supporting internal audits, Health Authority regulatory inspections, and system periodic reviews
Bachelor’s degree in Computer Science, Information Systems, Business Administration, or another related field is required, relevant experience may be substituted when appropriate
Minimum of 4-6 years of progressive industry experience, with direct experience in Computerized System Validation (CSV) in GxP environments
Experience authorizing and/or approving validation deliverables, Non-conformities, Change Requests, SOPs, Validation Plans, and Reports
Knowledge of Data Integrity and cGMP regulations related to CSV
Experience providing CSV support in at least one of the following areas: ERP, Laboratory, Manufacturing systems, medical device software, infrastructure qualification, hosted platforms, emerging technologies (e.g., AI, ML, RPA), or externally facing digital assets (e.g., mobile apps, Websites that include both static and dynamic processing)
Multilingual (Spanish, Portuguese, Chinese, Japanese, German, Dutch, or French)
Working knowledge of Quality Management Systems, PMO, SDLC, Testing, GAMP 5, and ITIL frameworks
Ability to perform work with a high degree of independence in terms of self-management of a variety of tasks
Solution-oriented and always striving for new ways to accomplish goals, and pragmatic advising in meeting compliance requirements
Works effectively in a virtual team environment and comfortable collaborating and communicating with various cross-functional groups
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.