Project Manager
Project Manager
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
10years
Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
Project Manager to lead and manage projects particularly in the development validation and FDA submission processes for pharmaceutical and medical device products.
- Develop project timelines resource allocation plans and budgets ensuring timely and onbudget delivery.
- Coordinate and oversee all stages of project execution from design development and validation through to FDA submission.
- Lead and manage complex projects related to the development commissioning process development and validation of aseptic pharmaceutical or medical device products.
- Ensure compliance with FDA and other regulatory bodies requirements particularly in aseptic areas and sterile manufacturing processes.
- Prepare and review documentation for FDA submissions and other regulatory filings.
- Work closely with internal stakeholders (R&D quality assurance operations regulatory affairs etc.) to ensure crossfunctional alignment and timely execution of project milestones.
- Manage risk assessments and mitigation strategies to address project challenges.
- Conduct periodic project reviews and provide status reports to senior management highlighting key project milestones risks and issues.
Requirements
- Bachelor s degree in Engineering Life Sciences or a related field (Masters degree preferred).
- 8 years of experience in project management in a regulated pharmaceutical biotechnology or medical device industry.
- PMP certified preferable.
- Proven track record of leading projects through FDA submissions.
- Bilingual (English and Spanish)
Employment Type
Full Time
