Project Director Aseptic Operations
hace 2 días
We are seeking an experienced Project Manager to lead our aseptic operations team. The successful candidate will have a proven track record of managing complex projects from design to FDA submission.
Key ResponsibilitiesThe Senior Project Manager Lead will be responsible for:
- Leading and managing cross-functional teams to achieve project objectives.
- Developing and implementing project plans, timelines, and budgets.
- Ensuring compliance with FDA regulations and good manufacturing practices (GMP).
- Collaborating with internal stakeholders to ensure effective communication and stakeholder engagement.
- Managing risk assessments and mitigation strategies to address project challenges.
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.
- Strong knowledge of FDA regulations, aseptic processing, validation protocols, and GMP.
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