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Sr Manager of Quality, Gene Therapy
Boston, MA  Posted: 10/15/2019


The Senior Manager is responsible for support and quality oversight for the assigned programs focused on Gene Therapy/ Biologics and possesses a strong knowledge of GCP study oversight and management of quality activities related to clinical trial execution and GMP cell-based production (drug development). The Senior Manager is knowledgeable in the principles and application of quality and regulatory compliance with significant knowledge of regulations applicable to Gene Therapy across the GCP/GMP areas. 
 The responsibilities of this position may include, but are not limited to, the following:
  • Provide strategic GCP quality compliance, oversight, and consultation supporting the Gene Therapy program
    • Provide regulatory compliance support & guidance to cross functional study teams
    • Ensure compliance with study protocol and study related procedures/ processes
    • GCP review and approval of applicable procedures (internal, external business partners and vendors)
    • Drive investigations to closure, facilitating root cause analysis and the development of effective CAPA plans
    • Participate in protocol deviation reviews
  • Support deployment of Quality Management System
    • Risk identification and communication
    • May participate on process improvement initiatives
    • Identify and perform KPI/ Metric analysis
  • Engage in preparation, support and follow-up activities related to Inspection Readiness
  • Review changes to applicable global regulations/ guidances and participate on cross functional team to assess impact to Quality Management System
  • Provide cross-functional support across QA as needed (e.g., Vendor Oversight, Audit and Inspection Management, etc.)
Minimum qualifications:
  • Master’s degree and 2-3 years of relevant work experience, or Bachelor’s degree in a scientific or allied health field (or equivalent degree) and 5-8 years of relevant work experience, or relevant comparable background
  • Experience/knowledge of biologics and/or gene therapy regulations and products
    • ICH E6 (R2), 21 CFR Part 50, 54, 56, 312, 314, and high level knowledge of 21 CFR Part 11 and International equivalents as necessary; best practices and industry standards


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