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
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
- 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
- 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
- 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
- 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
- This position will be based in Malvern PA and
may require up to 10% travel depending on business needs.
Janssen Biotech, Inc. (6014)Job Function