Project Manager
Project Manager
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
Project Manager to lead and manage projects in the aseptic areas particularly in the development validation and FDA submission processes for pharmaceutical and medical device products.
Responsibilities:
- Develop project timelines resource allocation plans and budgets ensuring timely and onbudget delivery.
- Coordinate and oversee all stages of project 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 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.
Qualifications :
- Bachelors 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 with a focus on aseptic areas and FDA submissions.
- PMP certified preferable.
- 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.
Additional Information :
All your information will be kept confidential according to EEO guidelines.
Remote Work :
Yes
Employment Type :
Contract
Employment Type
Remote
Company Industry
Key Skills
- Project Management Methodology
- Project / Program Management
- Construction Estimating
- Construction Experience
- PMBOK
- Visio
- Construction Management
- Project Management
- Project Management Software
- Microsoft Project
- Project Management Lifecycle
- Contracts
