Manager Aseptic Pharmaceutical Projects
hace 2 días
The Qrc Group, LLC is seeking an experienced Project Manager to join our aseptic operations team. As a Senior Project Manager Lead, you will be responsible for leading and managing complex projects from design to FDA submission.
Responsibilities and RequirementsResponsibilities:
- Lead and manage cross-functional teams to achieve project objectives.
- Develop and implement project plans, timelines, and budgets.
- Ensure compliance with FDA regulations and good manufacturing practices (GMP).
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, aseptic processing, validation protocols, and GMP.
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