Program Manager Lead

hace 2 días


San Juan, San Juan, Puerto Rico Qrc Group Llc A tiempo completo

Qrc Group Llc is seeking a highly skilled Program Manager Lead to oversee projects in the aseptic areas. This individual will be responsible for managing projects from design, development, and validation through to FDA submission.

The ideal candidate will have a proven track record of leading projects through FDA submissions and possess strong knowledge of FDA regulations (CFR Part 210/211, 21 CFR Part 820), aseptic processing, validation protocols, and good manufacturing practices (GMP).

  • Develop project timelines, resource allocation plans, and budgets.
  • Ensure compliance with FDA and other regulatory bodies' requirements.
  • Prepare and review documentation for FDA submissions.

This role requires a Bachelor's degree in Engineering, Life Sciences, or a related field, and 8+ years of experience in project management in a regulated pharmaceutical, biotechnology, or medical device industry.


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