Sr. Manager of Enterprise Quality CSV

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:

Multi-Family Quality

Job Category:

People Leader

All Job Posting Locations:

Horsham, Pennsylvania, United States of America, Raritan, New Jersey, United States of America

Job Description:

We are searching for the best talent for a Sr. Manager of Enterprise Quality CSV to be located in Raritan, NJ and/or Horsham, PA.

Purpose:

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 Sr. Manager of Enterprise Quality CSV is responsible for building and execution of quality into enterprise-wide systems, tools, services and infrastructure through the end-to-end lifecycle (design, develop, implement, maintain, retire).

You will be responsible for:

• Manage the end-to-end quality process and strategies for building and execution of applications and supporting infrastructure across Complaint Handling, Service & Repair, Event Management and Commercial Systems.
• Ensure that all J&J quality standards and global regulatory requirements are being met.
• 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.
• 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/guidance to the project teams as well as aligning with both internal and external stakeholders.
• Support internal audits and Health Authority regulatory inspections.
• 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
• Lead global diverse teams in an inclusive environment.
• Provide an environment which encourages the company’s credo and the value of a diverse workforce.
• Serves as a trusted partner across the Enterprise Quality organization, requiring strong collaboration skills at the senior leadership level, and includes making recommendations for improvements relevant to senior level stakeholder.

Qualifications / Requirements:

• A minimum of a Bachelor’s degree in Computer Science, Information Systems, Science, Engineering or related field is required.
• A minimum of 8 years of work experience in the pharmaceutical, medical device, and/or biotech industry, with direct experience in Computerized System Validation and/or Quality activities is required.
• A minimum of 5 years of people management experience is required.
• Experience in running large scale end-to-end Validation programs like LIMS, CAPA, MES, PLM, SAP, LMS, Complaints Handling, and/or Change Control is required.
• Experience authoring or approving validation protocols, non-conformities, Change Requests, SOPs, Validation Plans and Reports is required.
• Knowledge of SDLC Quality Management process and Computerized System Validation/Computerized System Assurance principles is required.
• Thorough knowledge of cGMP regulations related to CSV, including 21 CFR Part 11, Part 210, Part 211 and Part 820 is required.
• Knowledge of the following technologies and me