Director, Quality Assurance Operations-CAR-T

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:
People Leader

All Job Posting Locations:
Raritan, New Jersey, United States of America

Job Description:

Johnson & Johnson Innovative Medicines is recruiting for the Director, Quality Assurance Operations– CAR-T Manufacturing.  This position will be based in Raritan, NJ.

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

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.

Position Summary:

The Director, Quality Assurance Operations, Raritan CAR-T leads and handles all aspects of Quality Operations in support of the Raritan CAR-T manufacturing site, in full compliance with established cGMP, J&J and JSC requirements.

Functions and activities include Quality oversight of QA Incoming, QA Shop Floor, Batch Record Review, Drug Product Release, Cryopreservation, Lenti, and QCBB production facilities.

Manages a team of people leaders and technical professionals within the QA based on assigned work, direction, mentoring and developing capabilities.

Develops and implements long-term strategies, and execution of Quality programs.

We are seeking a dynamic and experienced Director, Quality Operations to join our team at Raritan CAR-T.

In this pivotal role, you will be responsible for driving the Quality Operations strategy for our site, ensuring that all quality standards are met and maintained throughout our operations.

The ideal candidate will possess strong leadership skills, a deep understanding of quality management systems, and a commitment to excellence in delivering safe and effective therapies to patients.

Key Responsibilities:


* Develo...