Project Manager - Remote

Overview

The Project Manager will lead and manage projects in the aseptic areas, particularly focusing on the development, validation, and FDA submission processes for pharmaceutical and medical device products.

In Short

• Develop project timelines, resource allocation plans, and budgets.
• Coordinate and oversee all stages of project execution.
• Lead and manage complex projects related to aseptic pharmaceutical or medical device products.
• Ensure compliance with FDA and regulatory requirements.
• Prepare and review documentation for FDA submissions.
• Work closely with internal stakeholders for project alignment.
• Manage risk assessments and mitigation strategies.
• Conduct periodic project reviews and provide status reports.

Requirements

• Bachelor’s degree in Engineering, Life Sciences, or related field (Master's preferred).
• 8+ years of project management experience in regulated industries.
• PMP certification preferable.
• Proven track record of leading projects through FDA submissions.
• Strong knowledge of FDA regulations and aseptic processing.
• Experience with process validation and equipment qualification.

Benefits

• Confidentiality of applicant information maintained.