Available Positions

Director QA- Gene Therapy at Pharmaceutical Company in Princeton, New Jersey, United States —

  • Pharmaceutical
  • Pharmaceutical Company
  • Princeton, New Jersey, United States
  • 8/12/19

Job ID: 136401

Job Description

The Director, Quality Assurance - Gene Therapy (GTx) QA is responsible for: 

  • Follows all applicable regulatory requirements, cGMP guidelines, and industry guidance documents as required by the job function
  • Provides QA review and approval of qualification/validation protocols and reports for manufacturing processes, cleaning processes, equipment and facility validation activities
  • Provides QA review and approval of qualification/validation protocols for analytical methods and product specifications
  • Provides QA review and approval for new and existing procedures, master batch records, change controls, deviations and investigations
  • Understanding of Quality by Design (QbD) principles as they relate to GTx manufacturing
  • Represent QA in risk assessment activities for the GTx programs
  • Provides QA oversight of GTx Contract Manufacturing Organizations (CMOs)
  • Ensures all work is performed and documented according to approved standard operating procedures, in general compliance with cGMPs and in a timely manner consistent with agreed upon schedules
  • Proficient in process and data review within respective scientific field of operation in accordance with job responsibility and function, able to troubleshoot product, process, and analytical-related issues
  • Regularly meets with QA management team in the development of best practice standards, KPIs, identification of training needs and optimization of resource utilization
  • Ensure compliance to all compendia and internal requirements (SOPs, Quality Agreements, General and Informational Chapters in multiple compendia as applicable)
  • Performs other duties related to the position when required by management

Qualifications

  • Minimum of BS or equivalent in the life sciences or engineering 

 Experience and Skills 

  • Must have a minimum of 7-10 years’ experience in the pharmaceutical/biotech industry.  
  • At least 5 years’ experience with GTx QA is preferred
  • Experience with managing direct reports
  • Working knowledge of FDA and EMA GXP regulations and ICH guidance documents
  • Experience in developing, reviewing and approving cGMP related documents (batch records, SOPs, protocols, reports, etc.)
  • Experience in the manufacture of GTx products is desired 
  • Experience in reviewing investigations, evaluating root cause and corrective action plans
  • Experience in overseeing and managing CMOs

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