Senior Manager CQV

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:

Supply Chain Engineering

Job Sub Function:

Quality Engineering

Job Category:

People Leader

All Job Posting Locations:

Raritan, New Jersey, United States of America, Spring House, Pennsylvania, United States of America, Titusville, New Jersey, United States of America

Job Description:

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at https://www.jnj.com/innovative-medicine.

We are searching for the best talent, Senior Manager, CQV. This Hybrid position can be based in Titusville, New Jersey, Springhouse Pa, or Raritan, New Jersey.

#LI-Hybrid

CAR-T is an innovative treatment, which uses the power of the patient’s own immune system. A patient’s T-cells are genetically modified to eliminate cancer cells. This ground-breaking technology provides hopeful prospects to patients where other therapies have failed or fail to provide adequate results. JJIM is working to develop, manufacture, and commercialize products in the CAR-T space. 

The CAR-T Engineering organization provides ownership and oversight for the entire asset portfolio and associated business processes for JJIM’s Advanced Therapies Supply Chain. Along the lifecycle of our assets, such as facilities, equipment, execution systems and utilities, this role is the key point of contact for all technical matters related to Commissioning, Qualification & Validation. The CAR-T (CQV) Lead is responsible for providing compliance expertise, using J&J standards, oversight, and development of internal as well as external partnerships at the site level and beyond, with a focus on Commissioning, Qualification, Re-qualification, and Validation within the JJIM CAR-T facilities. 

The Lead will provide day-to-day management of C&Q and requalification activities, and work closely with different teams, vendors, sites, and partners. In addition, they will create and sustain continuous procedural improvements to boost efficiency of C&Q activities. During Health Authority inspections and audits, they are the first point of contact for asset & facility qualification-related matters and serve a leading role to ensure successful outcomes. Daily, the CQV Lead partners with Operations, MSAT, Quality, and 3rd party partners, as well as Environment Health & Safety.

The CQV Lead will partner closely with global E&PS and Quality to ensure validation strategies are aligned with J&J standards and meet operational requirements. You will own the development and execution of the Project Validation Master Plan (PVMP) and ensure on-time qualified system turnover to the end user. 

Key Responsibilities:
•    Ownership for the development and execution of the Project Validation Master Plan (PVMP) 
•    Support the writing and approval of URSs (User Requirement Specifications) for facilities, equipment and systems.
•    Ensure flawless execution of Commissioning, Qualification, and Re-qualification works for manufacturing and laboratory equipment, execution systems, as well as facilities and utilities
•    Lead the writing and execution of Impact Assessments for equipment and facilities, IQ & OQ, and Re-qualification, as well as PQ activities 
•    In partnership with E&PS own Computer Systems Validation, including writing and driving CSV protocols, Functional Specification (FS), Design Specification (DS) plus Functional Acceptance Test (FAT) and Site Acceptance Test (SAT), Integration testing (IQ), and Functional testing (OQ)
•    Accountable for cost and resources within system(s) of responsibility
•    Support resolving