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External Quality Manager- Small Molecules, Americas

Company: Johnson & Johnson
Location: Horsham
Posted on: February 25, 2021

Job Description:

Job DescriptionJanssen Supply Group, LLC, a member of Johnson & Johnson's Family of Companies, is recruiting for an External Quality Manager- Small Molecules, Americas located ideally Titusville, NJ or Horsham, PA. May also consider other location in close proximity to a J&J site in New Jersey or Pennsylvania. Would consider other J&J US location including remote US location with travel to NJ or PA as needed.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 Supply Group, LLC, is part of the Janssen Pharmaceutical Companies.This position will provide quality oversight and technical support for External Manufacturers (EM) in the Americas. Ensure the effective and compliant execution of quality systems at the EM sites. Responsibilities include but not limited to review and approval of deviations, failure investigation, development of corrective action plans and monitor implementation. Review and approve EM quality system documents, specification and manufacturing instruction to ensure Janssen products/process comply to cGMP and regulatory requirements. Provide QA support for technology transfer and improvement of existing manufacturing processes. Monitor quality performance of EM, proactive identification of risk and lead improvement program to mitigation EM risk. Influence and build relationship with internal and external partners to continuously enhance quality culture and business excellence (PEx, Lean etc.).* Provide quality oversight to the selection, development and monitoring of EMs* Monitor trends, identify quality issues, recommend and implement appropriate actions.* Ensure cGMP compliance by EM in quality investigation, deviation and CAPA management. Review and approve deviations and product disposition decision.* Position requires occasional travel to External Manufacturer's sites to provide on-site cGMP assistance and quality oversight* Collaborate and support EM site during regulatory inspections. Approve, monitor and follow up on responses to regulatory agencies.* Develop, implement, review and approve SOPs, specification, quality system documents.* Investigate customer product quality complaints.* Apply cGMP regulations, FDA and other international requirements to all aspects of the position.* Coordinate change control review and approval process.* Lead EM risk management programs to maintain site qualification* Provide Quality oversight and participate on technology transfer and new product introduction project teams* Support Regulatory Submissions activities.* Lead EM PAI readiness program in coordination with EM, Compliance, development team and project team.* Maintain Quality Agreements and specifications changes* Drive continuous improvements and engineer quality into the process* Monitor trends, identify risk, troubleshoot, escalate to senior management as necessary.* Lead Escalation as defined in SOP, provide quality leadership in issue management and risk mitigation plan* Interface with other functions (Operations, Planning, Technical Operations, Local Affiliates etc.) in the support of supply chain to meet patient supply requirements.* Assess current quality systems, identify and implement improvements to enhance reliability and reduce cycle time.Qualifications* Bachelor's degree required; Advanced degree preferred* Minimum of 8 years in a FDA regulated environment is required; preferably in a pharmaceutical / biologics / device manufacturing and/or quality environment* Demonstrated knowledge of Pharmaceutical and/or Medical Device Quality Assurance, Quality Control and Compliance required* Experience in managing regulatory inspections and interaction with inspectors highly preferred* Experience providing cGMP compliance support to contract manufacturers by investigating and resolving quality issues is preferred* Experience in the development, implementation and review of SOPs for interactions with contract manufacturers is preferred* Experience investigating customer Product Quality Complaints is preferred* Experience managing regulatory inspections preferred* Strong interpersonal and written/oral communication skills required* Ability to work independently in support of a portfolio of products and suppliers required* Ability to quickly process complex information and make critical decisions with limited information required* Demonstrated leadership skills along with ability to influence without authority required* Experience building strong collaborative relationships, considering diverse perspectives and styles required* Proficiency in computer applications such as the MS Office suite is required* Position requires a minimum of 30% travel to external manufacturing sitesJohnson & 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

Keywords: Johnson & Johnson, Philadelphia , External Quality Manager- Small Molecules, Americas, Executive , Horsham, Pennsylvania

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