Software Quality Assurance Director jobs in New Jersey

Description

Janssen Pharmaceutical, a member of Johnson & Johnson's Family of Companies, is recruiting for a Director, Quality Assurance Operations- CAR-T Manufacturing ! This position will be located in Raritan, NJ.

At Johnson & Johnson, we believe good health is the foundation of vibrant lives, thriving communities and forward progress. As the world's largest and most broadly-based healthcare company, we are committed to using our reach and size for good. We strive to improve access and affordability, create healthier communities, and put a healthy mind, body and environment within reach of everyone, everywhere. Every day, our more than 130,000 employees across the world are blending heart, science and ingenuity to profoundly change the trajectory of health for humanity.

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.

Position Summary:

The Director, Quality Operations Head, Raritan Cell Therapy Manufacturing Operations 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 and 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.

Key Responsibilities:

• Drives the strategy and adherence to cGMP compliance for the site.
• Proactively identifies recurring trends, and implements a Right First Time program in collaboration with manufacturing and QC operations to reduce deviations and improve efficiency.
• 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.
• 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 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.
• 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

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.
• 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.
• Excellent communication, interpersonal relation, 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 142,000- 284,000USD$
• - Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
  Employees may be eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).
  This position is eligible to participate in the Company's long-term incentive program.
  - Employees are eligible for the following time off benefits:
  - Vacation - up to 120 hours per calendar year
  - Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year
  - Holiday pay, including Floating Holidays - up to 13 days per calendar year
  - Work, Personal and Family Time - up to 40 hours per calendar year

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