Manager External Quality Cell Therapy

Company: Disability Solutions
Location: Raritan
Posted on: February 8, 2025

Job Description:

Johnson and Johnson Supply Chain is recruiting for a Manager External Quality Cell Therapy! This position can be located in the New Jersey or Pennsylvania area.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.The External Quality Manager is responsible for managing 1) External Apheresis collection partners and, 2) Cell collection Laboratories (that perform Cryopreservation activities) for clinical and commercial CAR-T Products. The manager would be responsible for providing quality oversight, qualification of external sites, and drive global continuous improvement projects. Job duties are performed within a team schedule and collaboration with key partners!Key Responsibilities:

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• Responsible for quality oversight and qualifying external apheresis and cell collection laboratories/cryopreservation facilities.
• Continuously supervise all aspects of site performance and provide direction to site leaders to ensure quality compliance with regulatory requirements.
• Coordinate and provide concurrences on deviations, change controls and CAPAs. Develop, implement, and review SOPs for interactions with External Partners
• Provide leadership and insights as a member of global project team. Monitor trends, identify issues, recommend, and implement appropriate actions
• Exercise strong communication and interpersonal skills, with the ability to work independently and in a team environment, to effectively support supplier relationship/collection sites
• Review relevant regulatory documents prior to submission
• Perform tasks in a manner consistent with the safety policies, quality systems and cGMP/GTP requirements under limited supervision
• Adaptable and flexible for other duties that may be assigned as needed\r\r

Keywords: Disability Solutions, New Brunswick , Manager External Quality Cell Therapy, Executive , Raritan, New Jersey