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Project Manager - QA

  1. North America, United States
North Carolina
  1. Contract
Competitive
  1. CAPEX Projects
36143

This vacancy has now expired

Project Manager - QA - PMO - Pharma - North Carolina - 12-Month Contract 

Our client, a global pharmaceutical manufacturing organization are looking for a talented Project Manager to join their expanding team. With continued organizational growth and considerable investment across their portfolio and capital programs this is an extremely exciting opportunity to contribute towards their brand-new manufacturing facility on the East Coast of the United States.


Key Responsibilities:
  • Assess the current state of quality systems, identify gaps, and create a comprehensive plan to prepare the site for regulatory inspections.
  • Oversee the implementation of GMP documentation, change controls, deviation management, and CAPAs, ensuring alignment with FDA, EMA, and ICH guidelines.
  • Lead quality-related projects focused on validation readiness, data integrity, training programs, and compliance initiatives, ensuring smooth site startup and operational success.
  • Partner with CQV, Manufacturing, Supply Chain, and Regulatory teams to align quality objectives with startup timelines and ensure seamless integration of QA processes.
  • Act as a QA SME, providing guidance, oversight, and coaching to ensure site teams understand compliance expectations and regulatory best practices.
  • Develop and optimize quality workflows, audit strategies, and deviation management frameworks to enhance site-wide compliance.

Required Skills & Experience:
  • Proven experience in quality assurance project management within biotech or pharmaceutical manufacturing, with a focus on GMP compliance, validation, and regulatory inspection readiness.
  • Strong understanding of quality risk management, data integrity (ALCOA+), and quality system frameworks.
  • Ability to "speak the language" of compliance, quality systems, and site readiness—understanding regulatory expectations, audit preparation, and deviation management.
  • Hands-on experience with batch record review, change control, SOP development, and CAPA implementation.
  • Expertise in hosting and preparing for regulatory inspections (FDA, EMA, MHRA, etc.), ensuring that teams are aligned and prepared for site audits.
  • Excellent time management, problem-solving, and communication skills, with the ability to adapt in a fast-paced, evolving environment.
  • Experience managing KPIs, reporting structures, governance meetings, and infrastructure planning.
  • Ability to build relationships and effectively collaborate in a global team environment.

If this role is of interest to you, please apply now! 

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