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Quality Manager, Compliance

  • Date Posted April 13, 2021
  • Location Boston, MA
  • Job Type Contract
  • Job ID 17626

Quality Manager, Compliance

Our client, a leading pharmaceutical company focused on discovering, developing, manufacturing and commercializing treatments, is currently seeking a Temporary Quality Manager, Compliance to join their GMP Operational Quality group for a 6-month contract with the possibility of conversion to permanent. This person will be responsible for managing real time inspection readiness activities and serving as an expert in the principles and application of quality assurance and compliance.

This opportunity is a remote position but candidates must be local to the Boston area.

Responsibilities:

  • Real-time Inspection Readiness
    • Manage Inspection Readiness Plans associated with regulatory filings
      • Work with internal teams on key issues to ensure inspection readiness
      • Understand timelines and interdependencies
    • Assist with developing and providing oversight of mitigation plans
    • Communicate risks
    • Utilization of tools to ensure efficiency in execution
    • Assist in maintenance of opening presentation, Site Master File, SME list and storyboards
  • Management of vendor certificates and declarations to support GMP activities
    • Work with regional regulatory representatives to understand renewal schedule
    • Request required documentation from CMOs / internal team
  • Assist with Quality Management Review
    • Maintain QLT documentation and action items

Qualifications:

  • Master’s degree and 3 – 4 years of relevant work experience, or Bachelor’s degree in a scientific or allied health field and 8+ years of relevant work experience
  • Proficient at creating tools and processes for efficient execution
  • Experience with electronic document management systems (e.g., QDoccs, Veeva)
  • Proficient communication skills to facilitate successful cross functional collaboration
  • Project Management Skills preferred
  • Knowledge and application of:
    • GMP/GDP regulations and application to Manufacturing and Testing risk management principles
    • Root Cause Analysis tools/methodology and CAPA
    • Audit process
  • Operational QA experience in analytical or manufacturing setting with experience with the following is preferred:
    • Inspection support roles
    • Quality Systems
    • Interpretation and application of GMPs and applicable guidelines/guidances (e.g., ICH, USP, etc.) or other industry best practices (e.g., ISPE, WHO, etc.)
    • Experience with small molecules, biologics, devices, gene therapy a plus.
  • Must be authorized to work in the United States without sponsorship

If you are interested in this position, please send your resume to apowell@daleyaa.com

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