Vein to Vein Supply Chain Operations Quality Lead

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

Business Process Quality

Job Category

Professional

All Job Posting Locations

Raritan, New Jersey, United States of America

Job Description

About Innovative Medicine

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 for a Vein to Vein Supply Chain Operations Quality Lead to join our Team in Raritan, NJ.

An internal pre-identified candidate for consideration has been identified. However, all applications will be considered.

Janssen Biotech, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson, and Legend Biotech USA Inc., have entered into a global, strategic collaboration to develop, manufacture, and commercialize a chimeric antigen receptor (CAR) T-cell therapy. This innovative strategic partnership is designed to combine the strengths and expertise of two companies to advance the promise of an immunotherapy CAR-T platform and investigational treatment.

Are you interested in joining a team that is on the front lines supporting the CAR-T Patient Journey? Apply today for this exciting opportunity!

Summary

The Vein to Vein Supply Chain Operations Quality Lead will play a pivotal role in ensuring operational excellence and compliance within the Vein-to-Vein (V2V) Operations Team. This position is responsible for driving Quality Management System (QMS) initiatives, improving documentation, supporting audits, and leading quality-focused projects while serving as a Subject Matter Expert (SME) for COMET and other critical systems.

Key Responsibilities included, but not limited to:

• Quality & Compliance: Streamline processes for managing NCs, CAPAs, Change Controls, and investigations; provide audit support and lead QMS projects to ensure compliance and operational excellence across global and regional teams.
• Documentation & Process Improvements: Enhance controlled documentation (SOPs, Work Instructions, training materials) and maintain global/regional Vein-to-Vein manual updates for consistency and regulatory alignment.
• Training & Development: Design and deliver standardized training programs; update curriculum for process and system changes; act as COMET SME while promoting global understanding of quality management processes.
• Quality-Focused Projects: Lead and support internal/external quality initiatives to improve operational readiness and customer experience with a focus on global harmonization of best practices.
• Operational Support: Assist with day-to-day tasks, provide ad hoc Vein-to-Vein order management support, and monitor training performance metrics for continuous improvement.

Education

• Minimum Bachelor's or equivalent University Degree required; focused degree in Engineering, Supply Chain, or other equivalent field preferred

Experience and Skills

Required

• Minimum 6 years of relevant professional experience in healthcare industry is required. A mix of experience in the following areas is preferred:
• Supply Chain
• Quality
• Oncology, CAR-T, or Cell & Gene Therapy Experience
• Training and Training Development
• Investigations
• Strong understanding of end-to-end Vein-to-Vein process for Advanced Therapies Supply Chain, and supporting systems.
• Experience with training, quality monitoring, and documentation management systems (eg: TruVault, Summit, COMET.) is strongly preferred.
• Experience with Chain of Custody and Chain of Identity.
• Excellent communication skills (written and oral). Ability to summarize and present results effectively through all levels of the organization.
• Skilled in problem solving & using personal knowledge and any other available resources to work through ambiguous situations.
• Can dynamically adjust priorities due to changing circumstances. An agile learner who is comfortable operating in complex environments and shielding customers from that complexity.
• Ability to lead an ambiguous environment; highly organized and capable of working on a cross-functional team.
• Demonstrates a sense of urgency and is motivated by the challenge of working in a fast-paced environment; exercises calm, sound, constructive judgment during demanding situations.

Preferred

• Experience in cell therapy, biologics, or personalized medicine supply chains.
• Experience, understanding and teaching complex programs is strongly preferred.

Other

• Requires up to 10% domestic travel.
• Ability to work in a dynamic environment with flexible hours (weekends/off hours) for patient support.

Required Skills

Preferred Skills

Business Process Management (BPM), Business Requirements Analysis, Business Savvy, Coaching, Communication, Compliance Management, Cross-Functional Collaboration, Data Savvy, Fact-Based Decision Making, ISO 9001, Leverages Information, Operational Excellence, Problem Solving, Process Optimization, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Standard Operating Procedure (SOP)

The anticipated base pay range for this position is :

$94,000.00 - $151,800.00

Additional Description for Pay Transparency

Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).

Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:

• Vacation -120 hours per calendar year
• Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado -48 hours per calendar year; for employees who reside in the State of Washington -56 hours per calendar year
• Holiday pay, including Floating Holidays -13 days per calendar year
• Work, Personal and Family Time - up to 40 hours per calendar year
• Parental Leave - 480 hours within one year of the birth/adoption/foster care of a child
• Bereavement Leave - 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
• Caregiver Leave - 80 hours in a 52-week rolling period10 days
• Volunteer Leave - 32 hours per calendar year
• Military Spouse Time-Off - 80 hours per calendar year

Additional information can be found through the link below.

For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits