Aseptic Project Manager — FDA Submissions & Validation Lead

QRC Group; Aibonito (PR); On-site; USD 110,000 - 160,000; Full time

Job summary

QRC Group in Aibonito, Puerto Rico is seeking an experienced Project Manager to lead and manage projects in aseptic areas, especially in development, validation, and FDA submission processes for pharmaceutical and medical device products.

You will develop timelines, budgets, and resource plans, coordinate all stages from design to FDA submission, and ensure cross-functional alignment with R&D, QA, and regulatory affairs to deliver compliant, on-time results.

Qualifications

• 8+ years of project management experience in a regulated pharmaceutical, biotechnology, or medical device industry.
• Experience leading projects through FDA submissions and knowledge of CFR Part 210/211, 21 CFR Part 820.
• Experience with aseptic processing, validation protocols, GMP, and equipment qualification.
• Experience with process and cleaning validation in aseptic manufacturing.

Responsibilities

• Develop project timelines, resource allocation plans, and budgets.
• Coordinate and oversee all stages from design through FDA submission.
• Lead and manage complex aseptic projects in pharma or medical devices.
• Ensure compliance with FDA and other regulatory bodies' requirements.
• Prepare and review FDA submission documentation and regulatory filings.
• Collaborate with R&D, QA, operations, and regulatory affairs for cross-functional alignment.
• Manage risk assessments and mitigation strategies.
• Conduct periodic project reviews and provide status reports to leadership.

Skills

Project management

Regulatory affairs

FDA submissions

Cross-functional leadership

Risk management

Communication skills

Education

Bachelor's degree in Engineering or Life Sciences

Master's degree preferred

Job description

QRC Group in Aibonito, Puerto Rico is seeking an experienced Project Manager to lead and manage projects in aseptic areas, especially in development, validation, and FDA submission processes for pharmaceutical and medical device products.

You will develop timelines, budgets, and resource plans, coordinate all stages from design to FDA submission, and ensure cross-functional alignment with R&D, QA, and regulatory affairs to deliver compliant, on-time results.