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Quality

Quality Control Operations Manager

  • Titel Quality Control Operations Manager
  • Functie Quality
  • Sub functie Quality Control
  • Locatie Raritan, New Jersey, United States
  • Gepost
  • Referentie 2206082946W
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Beschrijving

Janssen Pharmaceuticals Inc., a member of Johnson & Johnson's Family of Companies, is recruiting for a Quality Control Operations Manager!

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 Biotech, Inc. is part of the Janssen Pharmaceutical Companies. Janssen Biotech, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson, and Legend Biotech USA Inc., have entered into a global, strategic collaboration to develop, manufacture, and commercialize a chimeric antigen receptor (CAR) T-cell therapy. This innovative strategic partnership is designed to combine the strengths and expertise of two companies to advance the promise of an immunotherapy CAR-T platform and investigational treatment.

Are you interested in joining a team that is positively impacting patients' lives by ensuring high quality in our pharmaceutical products? Apply today for this exciting opportunity!

The Quality Control Operations Manager is responsible for overseeing day-to-day Quality Control activities for a designated functional laboratory, ensuring GMP compliance, accuracy, and timeliness of specified testing processes. They carry out duties in compliance with all local, state, and federal regulations and guidelines (including FDA, EPA, and OSHA) as well as all company and site policies and procedures.

Key Responsibilities:

  • Manage Supervisors and provide operational guidance to schedule Contributes to global strategies related to QC laboratories which align with compliance and business objects as well as the overall J&J vision.
  • Manage departmental budget and resources; prepares staffing plans. Makes adjustments to roles and responsibilities of department to meet business needs.
  • Provides expertise in troubleshooting complex laboratory issues and demonstrates strong reasoning skills in support of ongoing laboratory investigations.
  • Collaborates with Quality Assurance, Manufacturing, Technical Operations, Engineering and Maintenance to support business needs.
  • Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements. Adherence in support Drug Product release testing cycle times
  • Review/approve QC laboratory data for validity and accuracy according to cGMP/cGLP standards
  • Review/approve documents as a QC department subject matter expert (SME)
  • Oversee timely completion of laboratory investigation of OOS/ invalid assays, CAPAs and change controls
  • Ensure accuracy and completeness of executed analytical method transfer activities
  • Communicate department objectives and metrics to staff
  • Support internal and Health Authority audits inspections
  • Support audit related investigations

Kwalificaties

Education:

  • Minimum of a Bachelor’s or equivalent degree required
  • Minimum four (1) years of relevant work experience or minimum one (1) years of direct management of staff
  • Proficient knowledge of analytical technologies used in a Quality Control laboratory and method transfer
  • Detailed knowledge and understanding of current Good Manufacturing Practices (cGMP) related to the QC laboratory and ability to identify/remediate gaps in processes or systems is required
  • Experience leading, coaching, or supervising direct or indirect personnel or teams
  • Ability to work nights and weekend shift required
  • Ability to occasionally lift up to 20 pounds required
  • Up to 5% of domestic travel required

Preferred:

  • Experience with ICH Q7 and/or 21 CFR parts 210, 211, 600, 601, and/or 610
  • Detailed knowledge of Compendial (e.g., USP, EP, JP, etc.) requirements and standards for QC testing
  • Experience in Cell and Gene therapy
  • Experience in Microbiology and Environmental Monitoring activities
  • Experience in Endotoxin and BacT sterility testing
  • Experience with LIMs and SAP or equivalent systems

The anticipated base pay range for this position is $93,000 to $159,850

At Johnson & Johnson, we’re on a mission to change the trajectory of health for humanity. That starts by creating the world’s 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 .

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