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Senior Manager, External Quality Small Molecules

Company: J&J Family of Companies
Location: Titusville
Posted on: September 24, 2022

Job Description:

Janssen Supply Group, LLC, a member of Johnson & Johnson's Family of Companies, is recruiting for a Senior Manager, External Quality (Small Molecules) located in Raritan, NJ or Titusville, 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. In this position you will provide end to end quality oversight for external manufacturers and strategic partners/alliances, ensuring consistent delivery of pharmaceutical products that meet or exceed safety, regulatory compliance, and product standards. Key Responsibilities:

  • Provide quality leadership and technical support to ensure effective execution of quality systems at external manufacturing sites
  • Manage quality oversight in the selection, qualification, and ongoing monitoring of external partners
  • 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 to meet patient supply requirements.
  • Influence external manufacturers to continuously improve processes and procedures focused on reliability, execution, and quality culture.
  • Collaborate with external manufacturers to support health authority inspections; monitor and follow-up on associated response and commitments.
  • Provide oversight for tech transfer and new product introduction activities.
  • Partner with external manufacturers to define the quality strategy through benchmarking and knowledge sharing.
  • Lead risk management initiatives necessary to improve performance. QualificationsEducation:
    • A minimum of a Bachelor's or equivalent University degree is required with a focus in life science, engineering, physical science preferred. Experience and Skills: Required:
    • A minimum of 8 years working in an FDA regulated environment.
    • Experience with quality support of clinical and commercial manufacturing operations.
    • Experience managing quality oversight for pharmaceutical production.
    • Detailed knowledge of current Good Manufacturing Practices related to pharmaceutical production.
    • Ability to work independently in support of a portfolio of products and suppliers.
    • Ability to quickly process complex information and make critical decisions with limited information.
    • Experience working on and leading cross-functional project teams.
    • Strong communication, influencing and leadership skills, demonstrating an ability to communicate at all levels of the organization. Preferred:
    • Experience working with external partners.
    • Experience with product transfer, new product introduction, medical devices, and advanced therapies.
    • Proficient in applying process excellence tools and methodologies. Other:
    • This role may require up to 25% of domestic & international travel. At Johnson & Johnson, were on a mission to change the trajectory of health for humanity. That starts by creating the worlds healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional and financial health of our employees and the ones they love. As such, candidates offered employment must show proof of COVID-19 vaccination or secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families and the communities in which we live and work. 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. For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com. Primary LocationUnited States-New Jersey-Raritan-1000 US HIghway 202Other LocationsNorth America-United States-New Jersey-TitusvilleOrganizationJANSSEN SUPPLY GROUP, LLC (6046)Job FunctionQualityRequisition ID2206072140W

Keywords: J&J Family of Companies, Trenton , Senior Manager, External Quality Small Molecules, Executive , Titusville, New Jersey

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