Enterprise Quality R&D Clinical Computer System Validation (CSV) Manager

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, and solutions are personal.

Through our expertise in Innovative Medicine and Med Tech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.

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As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Technology Product & Platform Management

Technology Operations Support

People Leader

Allschwil, Basel-Country, Switzerland, Allschwil, Switzerland, Beerse, Antwerp, Belgium, Horsham, Pennsylvania, United States of America, Raritan, New Jersey, United States of America

Johnson and Johnson is recruiting for an Enterprise Quality R&D Clinical Computer System Validation (CSV) Manager, located in either Horsham, PA;
Raritan, NJ;
Beerse, Belgium or Allschwil, Switzerland.

Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s):

United States - Requisition Number: R-093816

Europe – Requisition Number: R-094567

Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.

Enterprise Quality (EQ) manages the Quality and Compliance strategy for IT systems including applications, infrastructure and digital health solutions for J&J. EQ is the Subject Matter Expert (SME) for validation/qualification of both applications and infrastructure in accordance with J&J’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 closing compliance gaps related to audits and inspections.

The Enterprise Quality R&D Clinical Computer System Validation (CSV) Manager is responsible for guiding and managing the project team throughout the building and execution of quality into enterprise-wide systems, tools, services and infrastructure through the end-to-end lifecycle (design, develop, implement, maintain, retire).

• This role must ensure that all J&J quality standards and global regulatory requirements are being met
• This role ensures that building and execution activities include early involvement of quality in the design and development activities, building quality into the work product, building controls within the application/solution, and use of automation whenever feasible
• This individual will own the quality approach for systems and ensure teams are accountable for delivering on an end- to-end support model for systems in scope
• The role provides technical and procedural expertise/guidance to the project teams as well as aligning with both internal and external stakeholders
• The role is responsible for planning, task and resource allocations, executing, coordinating and maintaining the validation activities for GxP systems/applications
• This position will support internal audits and Health Authority regulatory inspections
• This position will be responsible for the approval of SDLC validation documentation deliverables including the approval to release system implementation and/or changes for production use, will attend project team meetings and provide EQ compliance guidance and support to project and base business support team members
• This role will lead globally diverse teams in an inclusive environment
• This role will provide an environment which encourages the company’s…