Senior Manager CQV

Senior Manager, CQV

Johnson & Johnson Innovative Medicines, Inc., a member of Johnson & Johnson's Family of Companies, is recruiting for a Senior Manager, CQV. This hybrid position can be based in Titusville, New Jersey, Springhouse PA, or Raritan, New Jersey.

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 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 of technical issues or roadblocks as fast as possible including lessons learned
• Support investigations, deviations, corrective and preventive actions towards successful timely and compliant closure
• Leading role in compliance inspections / audits within area of responsibility
• Ensure compliance with all applicable cGMPs, global regulatory requirements, safety, environmental regulations, SOPs, WI's and Company policies and corporate standards
• Provide leadership and act as expert in the field C&Q
• Maintain partnerships with contractors and vendors that execute C&Q, Re-qualification, and PQ activities
• Establish and manage critical metrics and tracking tools across C&Q scope
• Site requalification activities at the Quality Site Management Review (QSMR) level
• Actively communicate regularly with the Engineering community and foster expertise sharing with CAR-T entities around the globe
• Analyze processes to find opportunities for optimization, efficiency improvements, and cost savings. Furthermore, a portion of your time will be focused on developing detailed knowledge of CAR-T production processes :
• Develop & maintain in-depth understanding of the CAR-T manufacturing processes (including sound scientific understanding), operational procedures and manufacturing environment (Facilities, Utilities, Equipment, Systems, Processes)
• Develop & maintain robust understanding of aseptic and cell processing techniques.
• Develop & maintain an in-depth knowledge of cell processing robotics and automation.
• Develop & maintain understanding of relevant regulatory frameworks (general GMP and specific focus on ATMP)

Qualifications :

Preferred :

The anticipated base pay range for this position is $120,000 to $180,000.

Johnson & Johnson is an 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, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, contact us via https : / / www.jnj.com / contact-us / careers.