Senior Project Manager Lead
hace 2 días
The Qrc Group, LLC is a leading provider of innovative solutions for the pharmaceutical and medical device industries.
Job DescriptionJob Title: Senior Project Manager Lead
Reports to: Director of Aseptic Operations
Location: Remote (with occasional on-site visits)
Responsibilities:
- Lead and manage complex projects related to the development, validation, and commercialization of aseptic pharmaceutical or medical device products.
- Coordinate and oversee all stages of project execution from design, development, and validation through to FDA submission.
- 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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