Senior Manager, Technology Quality - Orthopedics Separation

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world 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 MedTech, 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. Learn more at https://www.jnj.com

Job Function:

Quality

Job Sub Function:

Quality Assurance

Job Category:

Professional

All Job Posting Locations:

Horsham, Pennsylvania, United States of America, New Brunswick, New Jersey, United States of America, Raritan, New Jersey, United States of America, West Chester, Pennsylvania, United States of America

Job Description:

We are searching for the best talent for a Senior Manager, Technology Quality – Orthopedics Separation, to be based in Raritan, NJ; New Brunswick, NJ; Horsham, PA; or West Chester, PA. This is an 18-24 month duration-based role.

Purpose: The Senior Manager, Technology Quality - Orthopedics Separation is responsible for successful execution and implementation of Separated GxP Computerized Systems in accordance with the defined business vision/strategy.

Technology Quality and Compliance (TQ&C) manages the Quality and Compliance strategy for IT systems including applications, infrastructure and digital health solutions for J&J. TQ&C 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.  A key function of this group is to utilize a data-driven approach to independent monitoring, to drive consistency of TQ&C processes, leading process improvements where gaps are noted.

Johnson & Johnson announced plans to separate our Orthopedics business to establish a standalone orthopedics company, operating as DePuy Synthes. The process of the planned separation is anticipated to be completed within 18 to 24 months, subject to legal requirements, including consultation with works councils and other employee representative bodies, as may be required, regulatory approvals and other customary conditions and approvals. Should you accept this position, it is anticipated that, following conclusion of the transaction, you would be an employee of DePuy Synthes and your employment would be governed by DePuy Synthes employment processes, programs, policies, and benefit plans. In that case, details of any planned changes would be provided to you by DePuy Synthes at an appropriate time and subject to any necessary consultation processes.

You will be responsible for:

• Leading TQ&C strategies for Separation of Depuy-Synthes business and related GxP Computerized Systems.
• Execute the Technology Quality (TQ) strategy for the Separation.
• Provide day-to-day operational support to manage Separation across the TQ organization.
• Implementing and executing the overall TQ Separation strategy and framework to include an assessment of IT systems for acquired businesses and developing a streamlined approach for divesting IT systems within the defined Quality Management Framework.
• Provide appropriate measures and monitoring for management reporting.
• Promote an environment which encourages the company’s credo and the value of a diverse workforce.
• Lead globally diverse teams in an inclusive environment.
• Serve as a trusted partner across the Technology Quality & Compliance organization, requiring strong collaboration skills at various levels within and outside the organization, and includes making recommendations for improvements relevant to senior level stakeholders.
• Ensure that all J&J quality standards and global regulatory requirements are being met (e.g. 21 CFR Part 11, Annex 11).
• Ensure 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.
• Own the quality approach for systems and ensure teams are accountable for delivering on an end-to-end support model for systems in scope.
• Provide technical and procedural expertise/guidan