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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 initiatives focused on process optimization, data-driven decision-making, and the application of quality improvement methodologies (e.g., Six Sigma, Lean).
• Monitor industry trends and emerging best practices to innovate and enhance quality processes within the organization.
• Ensures that all external customer complaints and internal complaints from affiliates are handled, evaluated and investigated in timely and effective manner, in conformance with cGMP's, Janssen Supply Chain Policies and Procedures.

Qualifications - External

Education:

A minimum of a bachelor's degree in Science is required, preferably in Biology, Microbiology, Chemistry, Pharmacy, Biochemistry, Chemical Engineering or related Science or Engineering.

Required:

• Demonstrated experience building and leading exceptional Quality Assurance teams.
• A minimum of 10 years relevant work experience, with 5 of those years managing a team of senior leaders and professionals within Quality Assurance.
• Experience with implementing and coordinating GMP operations in a commercial manufacturing facility.
• Experience leading process optimization initiatives, data-driven decision-making, and the application of quality improvement methodologies.
• Monitor industry trends and emerging best practices to innovate and enhance quality processes within the organization.
• Knowledgeable of Quality Risk Management concepts.
• Experience in regulated environment (FDA, EMA) and other worldwide regulatory agencies and regulatory inspections.
• Comfortable speaking and interacting with inspectors and senior leadership
• Excellent communication, interpersonal relation, presentation, collaboration, and influencing skills.

Preferred:

• Significant experience with Advanced Therapies is preferred.

Other:

• This position may require up to 10% domestic travel
• This position has an estimated annual salary of $146,000-$251,850  USD$

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,  external applicants please contact us via https://www.jnj.com/contact-us/careers . internal employees contact AskGS to be directed to your accommodation resource.

The anticipated base pay range for this position is :

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