Location: North Carolina
Duration: 12-Month Contract
Our client, a global pharmaceutical manufacturing organization, is looking for an excellent Project Manager to join their growing team. With continued organizational growth and significant investment across their portfolio and capital programs, this is a highly exciting opportunity to contribute toward their brand-new manufacturing facility on the East Coast of the United States.
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Evaluate the site’s current status in quality systems, determine which areas need strengthening, and propose an action plan for site-readiness on a regulatory inspection front.
Manage documentation related to GMP, maintain controls for changes and deviations, initiate CAPAs; follow guidelines in the context of FDA, EMA, ICH
Guidelines on specific projects, ensure site readiness as regards validation preparation, data integrity, training programs and compliance activities and get ready to set up for operations without setbacks.
Partner with CQV, Manufacturing, Supply Chain, and Regulatory teams to synchronize quality objectives with startup timelines, ensuring the quality assurance process fits well.
As a QA SME, guide and oversee the process, coaching the site teams on the expectations of compliance and regulatory best practices.
Design and optimize the quality workflows, audit strategies, and deviation management frameworks to help sites achieve more compliance.
Key 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!