Sr Mngr External Quality - Adv Therapies

Company: Disability Solutions
Location: Horsham
Posted on: February 1, 2025

Job Description:

Johnson & Johnson Innovative Medicine, is recruiting for an Senior Manager External Quality - Advanced Therapies! This position will be located in Raritan, NJ, Titusville, NJ or Horsham, PA!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/.You will lead the quality oversight for specified External Manufacturers (EM's) of radiopharmaceutical product, ensuring consistent delivery of product that meets all relevant safety, regulatory compliance, and product quality standards.You will provide QA support for technology transfer, EM qualification, manufacturing quality oversight and release and improvement of manufacturing and supply processes. You will monitor quality performance of the EM's, proactively identify risks and lead improvement programs to mitigate. This position may lead a work team as needed, located on-site as well as remote, that is responsible for delivering the site quality goals.Key Responsibilities

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• Provide quality leadership and technical support to ensure effective and compliant execution of quality systems at external manufacturing sites working in the radiopharmaceutical space
• Lead quality oversight in the selection, qualification, and ongoing monitoring of external partners
• Provide oversight for tech transfer and new product introduction activities in the radiopharmaceutical space; lead PAI readiness activities, and support associated health authority filings and approvals
• Daily management and coordination of the EQ work team supporting the EM as needed
• Lead the identification and resolution of quality issues and complaints, including facilitation of investigation process and development of robust CAPA plans.
• Review and approve quality systems documentation, including product disposition, manufacturing instructions, change controls, specifications, validation documentation, and technical studies
• Monitor quality performance through the development of key performance indicators; Analyze data to identify risks and drive implementation of mitigation plans
• Build relationships with internal and external partners; Influence external manufacturers to continuously improve processes and procedures passionate about reliability, execution, and quality culture
• Collaborate with the External Manufacturers to support health authority inspections; supervise and follow-up on associated response and commitments
• Partner with External Manufacturing sites to define the quality strategy through benchmarking and knowledge sharing.
• Lead risk management initiatives vital to improve performance
• Partner with key internal stakeholders in support of tech transfer and supply chain processes to meet patient supply requirements
• Assess current quality systems and recommend improvements to improve compliance and optimize processes\r\r\r

Keywords: Disability Solutions, East Orange , Sr Mngr External Quality - Adv Therapies, Healthcare , Horsham, New Jersey