The Role
Lead complex aseptic pharmaceutical and medical device projects from design and development through commissioning, validation, and FDA submission. Manage timelines, budgets, resources, risks, documentation, and cross-functional coordination across R&D, quality, operations, and regulatory teams. Ensure compliance with FDA regulations, GMP, aseptic processing requirements, validation protocols, and equipment qualification standards while reporting project status, milestones, risks, and issues to senior management.
Summary Generated by Built In
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 on-budget 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 cross-functional 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.
RequirementsRequirements
- 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.
- 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.
Skills Required
- Bachelor's degree in Engineering, Life Sciences, or a related field
- 8+ years of project management experience in the regulated pharmaceutical, biotechnology, or medical device industry
- Experience focused on aseptic areas and FDA submissions
- PMP certification
- Proven track record leading projects through FDA submissions
- Strong knowledge of FDA regulations, including CFR Part 210/211 and 21 CFR Part 820
- Knowledge of aseptic processing, validation protocols, and good manufacturing practices
- Experience with process validation, cleaning validation, and equipment qualification in aseptic manufacturing
- Master's degree
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The Company
What We Do
QRC Group specializes in providing expert consulting services in regulatory compliance, quality management, and risk management for the pharmaceuticals, medical devices, biotechnology, and other regulated industries, delivering comprehensive project management and validation solutions.
