Quality Assurance Senior Supervisor

Janssen Pharmaceuticals, Inc. a member of Johnson & Johnson's Family of Companies, is recruiting for a Quality Assurance Senior Supervisor- CAR-T! This position will be located in Raritan, NJ.

At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com and follow us @JanssenGlobal. Janssen Pharmaceuticals, Inc. is part of the Janssen Pharmaceutical Companies.

In this role, you will be leading a team of Quality Assurance specialists responsible for Quality oversight of clinical and commercial production of viral vectors supporting the advanced therapies product portfolio. You will act as a liaison with other internal quality organizations to standardize policies, practices and procedures to increase quality and compliance and champion increased awareness of quality related concerns.

Main responsibilities will include, but are not limited to:

• Collaborate with business partners and provide meaningful guidance to help facilitate resolution of issues across organizational boundaries.
• Ensure that cycle times are met within quality functional areas. Collaborate with your team to address delays or issues and identify and implement efficiencies to reduce E2E cycle times.
• Contribute to establishing and monitoring quality metrics that serve as a key method of communication while establishing and maintaining a climate of open communication, engagement and ownership.
• Cascade and translate strategic and tactical plans to foster your team's understanding of their contribution to achieving higher level goals including business unit and company business objectives.
• Other duties may be assigned as necessary.
• Lead the execution of the business plan by providing input on the site goals and objectives, prioritizing projects, and coordinating resource allocation to meet base business needs and support site and business initiatives related to quality and compliance.
• Provide leadership and insight as on global project teams.
• Create and maintain an environment that serves as a learning atmosphere and fosters diversity, equity, and inclusion
• Lead inspection readiness activities and internal and external audits.
• Maintain a high caliber team through performance management, succession planning, talent management, recruiting, staffing and making hiring decisions, and training and development processes. Train, develop, coach and mentor employees.

Qualifications

Education:

• A minimum of a Bachelor’s Degree is required, with a focused degree in Engineering, Science or equivalent technical field preferred.

Required:

• Ability to be organized and capable of working in a team environment with a positive demeanor.
• A high degree of accuracy and attention to detail, and excellent interpersonal, oral and written communication skills.
• At least 6 years of experience in a regulated manufacturing environment, preferably in biotechnology or pharmaceutical industry.
• Demonstrated experience directly supervising employees.
• Advanced knowledge of cGMP regulations and FDA/EU guidance related to biologics or cell and gene therapies.

Preferred:

• Ability to prioritize daily business needs while being flexible and adaptable to frequently shifting priorities.
• Ability to quickly process complex information and often make critical decisions with limited information.

Other:

This position may require up to 10% domestic & international 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.