Senior Project Manager

hace 2 días


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

Company Overview
Qrc Group, Llc is a leading provider of innovative solutions for the pharmaceutical and medical device industries. Our team of experts works tirelessly to deliver high-quality projects that meet the stringent requirements of regulatory bodies.

Job Description

  • We are seeking an experienced Senior Project Manager - Aseptic Operations to lead our projects in the aseptic areas, particularly in the development, validation, and FDA submission processes for pharmaceutical and medical device products.
  • The successful candidate will be responsible for developing project timelines, resource allocation plans, and budgets, ensuring timely and on-budget delivery.
  • They will coordinate and oversee all stages of project execution from design, development, and validation through to FDA submission.
  • This role requires 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 is highly desirable.

Required Skills and Qualifications

  • 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.
  • PMP certified preferable.
  • Proven track record of leading projects through FDA submissions.

Benefits

  • Opportunity to work with a leading provider of innovative solutions for the pharmaceutical and medical device industries.
  • Chance to develop your skills and expertise in aseptic operations and FDA submissions.
  • A dynamic and supportive team environment.


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