Project Director

hace 2 días

San Juan, San Juan, Puerto Rico Qrc Group, Llc A tiempo completo

Project Director - Pharmaceutical Manufacturing

We are seeking an experienced Project Director - Pharmaceutical Manufacturing to lead our projects in the pharmaceutical manufacturing sector. The successful candidate will have a strong background in project management, particularly in the aseptic areas, and a deep understanding of FDA regulations.

Key Responsibilities

  • Develop and implement project plans, including timelines, resource allocation, and budgets.
  • Coordinate and oversee all stages of project execution, from design to FDA submission.
  • Ensure compliance with FDA regulations, aseptic processing, and good manufacturing practices (GMP).
  • Manage risk assessments and mitigation strategies to address project challenges.
  • Collaborate with internal stakeholders to ensure cross-functional alignment and timely execution of project milestones.

Requirements

  • Bachelor's degree in Engineering, Life Sciences, or a related field (Master's degree preferred).
  • 10+ 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 desirable.
  • Strong knowledge of FDA regulations (CFR Part 210/211, 21 CFR Part 820), aseptic processing, and GMP.

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