• Full Time (Salaried)
  • ,

Company:  Confidential

Job Title: Quality Engineering Manager

Job Number: 34618


Job Description

We are seeking a QE Manager to join our team and lead our quality engineering efforts.  This position is responsible for providing Quality Engineering (QE) management on the qualification and GMP commercialization of our facility for our biologics products.  


  • Oversight of Commissioning, Qualification and Validation (CQV) for multiple locations
  • Work collaboratively with other site functions such as F&E, Safety, and the quality organization
  • Provide Quality support of the change control technical assessment/evaluation process
  • Align on change control requirements to manage the requested change in consultation with internal standards
  • Ensure alignment of system qualification with procedures
  • Support the site’s quality system management with eQMS implementation, measurement and control strategies
  • Support regulatory inspections and audits

Required Skills

  • 5 or more years experience in pharmaceutical or FDA environment
  • Minimum of 2 years of Quality Engineering experience in a GMP environment (Drug Substance or Drug Product)
  • Knowledge of quality systems and pharmaceutical regulatory requirements (21 CRF Part 11/210/211, ICH 8, ICH 9, and ICH 10)
  • Quality Engineering Certification, ASQ, Black Belt/Green Belt certifications, preferred
  • Strong understanding of automation, equipment and utility IQ/OQ/PQ/PV


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