Director, Quality Assurance Operations

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 Innovative Medicine, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found.  Johnson & Johnson Innovative Medicine discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, cardiopulmonary, and retina.  Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it.

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:

• Develops, implements and drives a comprehensive Quality Operations strategy, aligned with site goals.
• Leads the establishment and execution of quality objectives and key performance indicators (KPIs) that drive continuous improvement and operational excellence.
• Proactively identifies recurring trends and implements a Right First Time program in collaboration with manufacturing and QC operations to reduce deviations and improve efficiency.
• Ensure effective risk management practices are in place, including identification, assessment, and mitigation of quality-related risks.  Provides leadership and direction to the Quality and Site Management Teams to ensure business, quality and compliance goals are met following the J&J Standard of Leadership behavior model.
• Develops and champions an interpersonal culture that promotes behaviors that lead to outstanding business performance and organizational excellence.
• Ensure effective risk management practices are in place, including identification, assessment, and mitigation of quality-related risks.
• Responsible for appropriately staffing and developing the Quality Operations organization to meet budget and succession plans.
• Leads launches of new products and technologies. Participates in product stage gate reviews representing Raritan site Quality Assurance.
• Partners with the Compliance Team to prepare for and support Health Authority inspections at Raritan. Leads and hosts compliance audits. Serves as SME for QA operations to support all regulatory inspections.
• Lead initia