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Senior Manager, Quality Assurance Operations

Umoja BiopharmaLouisville, Colorado, United StatesNew
On-site Full-time $155K/yr - $191.5K/yr

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Experience Level

Senior Level Manager

Qualifications

Core Responsibilities:Promote and exemplify Umoja's quality culture. Build and lead a high-performing, solution-oriented QA Operations team that fosters strong cross-functional relationships. Oversee QA Operations to ensure compliance and oversight across GxP functions (e.g., controlled documents, change controls, deviations, CAPAs, work orders, etc.) at The CLIMB. Facilitate collaborative interactions with cross-functional partners to translate applicable regulations (e.g., FDA, ICH, EMA) into efficient internal procedures and practices according to phase-appropriate cGMPs.

About the job

Umoja Biopharma develops integrated immunotherapy platforms aimed at advancing new cancer treatments. The Louisville, Colorado site supports a growing team focused on drug development, working alongside colleagues in Seattle, WA. Umoja emphasizes diversity, collaboration, and scientific progress in its approach.

Role overview

The Senior Manager, Quality Assurance Operations leads GMP operations at The CLIMB, Umoja’s lentiviral vector development and manufacturing facility in Louisville. This leadership role manages the QA Operations team and is responsible for ensuring compliance across all GxP areas, including Manufacturing, Supply Chain, Facilities, and Engineering. The position plays a key part in upholding quality standards and supporting best practices throughout the site.

Location and schedule

  • Onsite role in Louisville, Colorado
  • Full-time, five days per week
  • May require work on weekends or holidays as needed

About Umoja Biopharma

Umoja Biopharma is a pioneering biotech company dedicated to transforming cancer treatment through innovative immunotherapy solutions. With locations in Seattle and Louisville, we are committed to developing groundbreaking therapies that address a wide range of tumors effectively. Our diverse team thrives in an environment that encourages innovation and collaboration, all while adhering to our core values and principles.

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