Head of Quality, Cell Therapy & Lentivirus Manufacturing

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:
Multi-Family Quality

Job Category:
Professional

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

Job Description:

Johnson & Johnson Innovative Medicine is recruiting for the Head of Quality, Cell Therapy & Lentivirus Manufacturing, Raritan. 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 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:

This exceptional and visionary leader will serve as the Head of Quality for our CAR-T Cell Therapy & Lentivirus Manufacturing facility in Raritan, NJ. This pivotal role will be central to leading and managing the oversight of Quality Assurance (QA) and Quality Control (QC) activities, guiding our site through its next phase of growth.

The Head of Quality will ensure full compliance with established current Good Manufacturing Practices (cGMP) and Johnson & Johnson requirements while overseeing vital functions, including Quality Control testing, Quality Assurance review and approval processes, validation procedures, compliance activities, and product release activities for both CAR-T and Lentiviral manufacturing. We are looking for a leader who will not only maintain our high-quality standards but also inspire and drive our team towards excellence as we advance in our mission to provide innovative therapies to patients.

Key Responsibilities:

• Quality Oversight and Compliance:
• Provide overall Quality oversight for cGMP operations encompassing both clinical and commercial manufacturing at the Raritan facility.
• Ensure adherence to applicable GMP regulations, as well as Johnson & Johnson policies and procedures for CAR-T and Lentiviral manufacturing processes.
• Strategic Leadership:
• Develop and implement long-term strategies and execution plans for Quality programs.
• Lead the site management review of Quality compliance and operational KPIs, ensuring timely mitigation of unfavorable trends.
• Collaboration and Partnership:
• Actively participate as a member of the Advanced Therapies Quality Leadership Team (ATQLT), ensuring alignment and harmonization with JSC Quality Policies, Guidelines, Programs, and Systems.
• Collaborate with the Site General Manager and CAR-T Senior Leaders to integrate Quality objectives within the overall site operations.
• Team Management and Development:
• Build and lead a high-performing team of QA/QC professionals, focusing on hiring, mentoring, and developing personnel to enhance capabilities within the department.
• Evaluate functional strengths and developmental areas within the Quality organization, fostering a continuous improvement culture.
• Regulatory Engagement:
• Lead and host compliance audits and regulatory inspections (e.g. FDA, IGJ, ANVISA, etc.)
• Develop and sustain strong relationships with regulatory authorities, providing expertise in interpreting governmental regulations and agency guidelines.
• Process Improvement and Quality Culture:
• Ensure that the necessary processes, procedures, systems, and resources are in place to support compliant manufacturing, testing, and distribution practices.
• Champion a positive quality compliance culture and create a diverse and inclusive workplace that encourages engagement and innovation.
• Financial Management:
• Develop appropriate operating and capital expense budgets for the Quality organization, focusing on contributions to improvement in turnaround time and Cost of Goods Sold (COGS).
• Manage all departmental goals to ensure timely completion of all deliverables.
• Operational Excellence:
• Collaborate with other leaders across the organization to support continuous improvement in GMP policies and the Quality Management System.
• Establish effective partnerships with business units, sites, and individuals to ensure business processes are seamlessly linked.
• Additional Responsibilities:
• Perform tasks in alignment with safety policies, quality systems, and cGMP requirements.
• Undertake other duties as assigned to support the organization's goals and objectives.

Qualifications

Education:

A minimum of a bachelor's degree in a scientific discipline is required, preferably in areas such as Biology, Microbiology, Chemistry, Pharmacy, Biochemistry, Chemical Engineering, or a related field in Science or Engineering.
Required:

• A minimum of 12 years experience in Quality Assurance/ Quality Systems related to manufacturing is required
• Minimum of 5 years managing a team of senior leaders and professionals within Quality Assurance.
• Significant experience in biologics and/or cell therapy manufacturing.
• Proven leadership skills in people management and Quality Assurance, Quality Systems and Quality Control.
• Demonstrated experience in hosting global regulatory health authority inspections, successfully presenting product and quality compliance programs to regulatory reviewers.
• Strong background in implementing and overseeing Good Manufacturing Practices (GMP) operations within a commercial manufacturing environment.
• A track record of building and leading exceptional Quality Assurance, Quality Systems, and Quality Control teams.
• In-depth knowledge of chemical, biochemical, and microbiological concepts.
• Experience with aseptic processing in ISO 5 clean rooms and biosafety cabinets.
• Comprehensive understanding of current Good Manufacturing Practice (cGMP) regulations and FDA/EU guidance.
• Familiarity with Quality risk management concepts.
• Experience in a regulated environment, including interactions with FDA, EMA, and other global regulatory agencies, along with experience in regulatory inspections.
• Comfortable in communicating and interacting with inspectors and senior leadership.
• Exceptional communication, interpersonal relations, presentation, collaboration, and influencing skills.

Other:

• This position may require up to 10% domestic travel

Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability.

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.