Project Manager

QRC Group, LLC; Aibonito (PR); In loco; USD 120.000 - 160.000; Tempo pieno

Descrizione del lavoro

QRC Group, LLC is seeking a seasoned Project Manager to lead projects in aseptic pharmaceutical and medical device areas, focusing on development, validation, and FDA submission processes. The role requires coordinating design, development, and validation activities while ensuring strict regulatory compliance.

The ideal candidate will have 8+ years in regulated industries, strong FDA knowledge (CFR Part 210/211, 21 CFR Part 820), and PMP certification is preferred.

Competenze

• Bachelor’s degree in Engineering, Life Sciences, or a related field.
• 8+ years of project management experience in regulated pharmaceutical, biotechnology, or medical device industries.
• PMP certification preferred; proven track record leading FDA submissions.

Mansioni

• 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) 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.

Conoscenze

Project management

Regulatory knowledge

Cross-functional leadership

Stakeholder communication

Formazione

Bachelor’s degree in Engineering, Life Sciences, or related field

Master’s degree preferred

PMP certification

Descrizione del lavoro

Project Managerto 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.

Requirements

• 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.