Quality Assurance Senior Supervisor, Batch Record Review

Janssen Pharmaceuticals, Inc. a member of Johnson & Johnson's Family of Companies, is recruiting for a QA Senior Supervisor, Batch Record Review!

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 Biotech, Inc. is part of the Janssen Pharmaceutical Companies.

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.

Are you interested in joining a team that is positively impacting patients' lives by ensuring high quality in our cell therapy products? Apply today for this exciting opportunity to be part of the #CAR-T team!

In this role, you will be leading a team of Quality Assurance specialists responsible for production batch record review and batch release activities as needed to support 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.
• 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.
• Create and maintain an environment that serves as a learning atmosphere and fosters diversity, equity, and inclusion
• 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.
• 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.
• 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.
• 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.
• Lead inspection readiness activities and internal and external audits.
• Provide leadership and insight as on global project teams.
• Other duties may be assigned as necessary.