Senior Project Manager Lead

hace 2 días


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

The Qrc Group, LLC is a leading provider of innovative solutions for the pharmaceutical and medical device industries.

Job Description

Job Title: Senior Project Manager Lead
Reports to: Director of Aseptic Operations
Location: Remote (with occasional on-site visits)

Responsibilities:

  1. Lead and manage complex projects related to the development, validation, and commercialization of aseptic pharmaceutical or medical device products.
  2. Coordinate and oversee all stages of project execution from design, development, and validation through to FDA submission.
  3. Develop project timelines, resource allocation plans, and budgets, ensuring timely and on-budget delivery.

Requirements:

  • Bachelor's degree in Engineering, Life Sciences, or a related field (Master's degree preferred).
  • 8+ years of experience in project management in a regulated pharmaceutical, biotechnology, or medical device industry, with a focus on aseptic areas and FDA submissions.
  • Proven track record of leading projects through FDA submissions.
  • Strong knowledge of FDA regulations (CFR Part 210/211, 21 CFR Part 820), aseptic processing, validation protocols, and good manufacturing practices (GMP).
  • Experience with process validation, cleaning validation, and equipment qualification in aseptic manufacturing.


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