Quality Control Manager
Location:
Malvern , Pennsylvania
Posted:
February 08, 2017
Reference:
6320170116-en-us

Janssen Biotech, Inc. is recruiting for a Quality Control Manager to be based in Malvern, PA.

 

At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found. 

 

Janssen Biotech, Inc. delivers on the promise of new treatments and ways to improve the health of individuals with serious disease. Built upon a legacy of innovative firsts, Janssen Biotech pursues advancing patient care with immunology and oncology solutions. Please visit www.JanssenBiotech.com for more information.

 

We are Janssen. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it.

 
The Quality Control Manager will:
  • Manage all aspects of Quality Control (QC), in support of designated Janssen Supply Chain (JSC) sites, and in full compliance with established cGMP and JSC requirements. 
  • Develop and implement long-term strategy, and execution of Quality Control programs. 
  • Ensure department staff complies with all J&J, JSC and government-issued environmental, health, safety, quality and regulatory policies and guidelines, including FDA, EMEA and regulatory bodies of any applicable non-EU countries.
  • Manage team of people leaders and technical professionals within the QC department. 
  • Assign work, provides overall direction, coaches and mentors, develops capabilities and takes necessary disciplinary actions.
  • Be responsible for overseeing and managing processes for:
    • Ensuring safety is a priority in the QC labs
    • Ensuring adequate training (skills-based, cGMP and safety) of management and associates within the department.
    • Raw material, in-process, environmental/utility, product release, and stability testing.
    • Investigation of laboratory non-conformances (events, deviations, and invalid assays).
    • Maintenance, calibration and qualification of laboratory instruments and equipment.
    • Test method verification, qualification, validation and/or transfer activities in the QC laboratories.
    • Process Performance Qualification and Continued Process Verification activities associated with QC laboratory testing.
  • Provide expertise in troubleshooting complex laboratory issues and demonstrates strong reasoning skills in support of ongoing laboratory investigations.
  • Collaborate with Quality Assurance, Manufacturing, Technical Operations, Engineering and Maintenance to support business needs.
  • Manage departmental budget and resources; prepare staffing plans.  Make adjustments to roles and responsibilities of department to meet business needs.
  • Review and/or approve quality documents (standard operating procedures, specifications, test methods, work instructions, risk assessments, technical/validation protocols and reports, etc.), non-conformance investigations, CAPA, and change controls associated with the QC laboratories.
  • Support internal and external audits, including external contract laboratories and GMP service providers, where required.
  • Manage strategic capital projects for the QC labs.


Qualifications
  • A minimum of a technical or science focused Bachelor’s degree (or equivalent degree) is required.
  • An advanced/graduate degree is preferred. 
  • A minimum of 8 years of experience in a FDA regulated environment is required.
  • Experience directing staff, and collaborating with management from other functional areas is required.
  • Advanced knowledge and understanding of regulatory requirements, including Safety, QA and QC functions, applicable cGMP compliance requirements and experience in regulatory inspections is required.
  • Extensive knowledge of chemical, biochemical and microbiological concepts is required
  • Ability to apply basic and advanced mathematical concepts (including statistics) in the evaluation of laboratory data is required
  • Expert-level understanding of new and emerging technologies and practices for regulated quality labs is required.
  • Prior experience managing a Quality Control laboratory is preferred.
  • Experience contributing to regulatory submissions, including Annual Reports, Investigational New Drug (IND) filings and Biologics License Applications (BLA) is preferred.
  • Prior experience working with Large Molecules is preferred.
  • This position will be based in Malvern PA and may require up to 10% travel depending on business needs. 


Primary Location
United States-Pennsylvania-Malvern
Organization
Janssen Biotech, Inc. (6014)
Job Function
Quality Control

A little about us:
Johnson & Johnson cares for the world - bringing innovative ideas, products and services to advance the health and well-being of people.

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