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QRC Group, Inc

Project Manager

QRC Group, Inc Aibonito

Staffing and Recruiting · 51-200 employees

4 d ago
project-manager Principal (10+ yrs) Contractor
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About the role

The Project Manager will lead and manage complex projects in aseptic areas, overseeing all stages from development and validation to FDA submission. They are responsible for project timelines, resource allocation, budget management, and ensuring compliance with regulatory requirements.

What they look for

Project Management Aseptic Processing FDA Submission Validation Regulatory Compliance GMP Risk Assessment Process Development Commissioning Quality Assurance Resource Allocation Budgeting Stakeholder Management CFR Part 210/211 21 CFR Part 820 Cleaning Validation

Requirements

Candidates must have a Bachelor's degree in Engineering or Life Sciences and at least 8 years of project management experience in a regulated industry. Strong knowledge of FDA regulations, aseptic processing, and a proven track record of successful FDA submissions are required.

Full description

Company Description

QRC Group, LLC is a firm dedicated to offer services to the Pharmaceutical, Medical Devices and Chemical Industries in the validation and regulatory fields.

Log on now to our website http://www.qrcgroup.com/ to learn more about our services and solutions!

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 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.

 

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.
  • 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 manufactur

Additional Information

All your information will be kept confidential according to EEO guidelines.

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