Senior Director, GMP Quality Assurance

Overview

Umoja Biopharma is a game‑changing biotech start‑up with locations in Seattle, WA and Louisville, CO, focused on transforming the treatment of cancer with a novel integrated immunotherapy platform. Our vision is to develop off‑the‑shelf therapies capable of treating any tumor, any time. We are a diverse and growing team working in brand‑new facilities in downtown Seattle, Washington, and Louisville, Colorado, and we are looking for innovative thinkers who are excited by groundbreaking science and technology, and passionate about squaring up to the challenges inherent to cutting‑edge drug development.

We are committed to the principles of Diversity, Equity and Inclusion and strongly invite applications from enthusiastic individuals who share our commitment and help position Umoja as a leader in this front.

The Sr. Director, GMP Quality Assurance (GMP QA) is responsible for overseeing all quality assurance operations for Umoja related to Good Manufacturing Practices (GMPs) for Umoja’s product portfolio across all phases of the product lifecycle. This senior leadership role will lead a GMP QA organization comprised of quality professionals supporting internal and external GMP manufacturing operations, quality systems, and oversight of GMP vendors.

As a senior leader within the company and Quality organization, this role will provide strategic leadership and direction, collaborating across all relevant internal and external stakeholders (e.g., Manufacturing, Supply Chain, Facilities & Engineering, CMC, Regulatory, etc.) to develop high performing & collaborative teams and mature and execute a comprehensive functional vision in alignment with company and organizational goals. The role will oversee and direct the maturation and continual improvement of GMP quality systems and processes that assure product quality & patient safety in accordance with Umoja quality principles and compliance with applicable laws, regulations, industry Standards and Health Authority requirements & expectations appropriate for applicable phases of the product lifecycle.

This role shall also serve as a member of the senior Quality Leadership Team to set and execute strategic initiatives, maintain and encourage a strong continual improvement mindset, and serve as a critical leader in establishing, maturing, and championing Umoja’s quality culture. This position is an on‑site role based at Umoja’s GMP manufacturing facility, The CLIMB, in Louisville, Colorado, and will report directly to the Head of Quality.

• Leading the GMP Quality Assurance (GMP QA) function at Umoja in support of Umoja’s multi‑product, multi‑jurisdiction, multi‑partner portfolio through all phases of development (e.g., Phase 1, Pivotal, PPQ, commercial launch, etc.)
• Building, mentoring, and leading a high‑performing GMP QA team, fostering a culture of quality, accountability, collaboration, and organizational flexibility & adaptability within the team and across the organization in alignment with Umoja’s values & principles and Umoja’s quality culture
• Developing, implementing, and executing a comprehensive organizational vision and strategy in alignment with Quality organization, site, and corporate goals & objectives
• Active engagement in Umoja’s Quality Leadership Team (QLT) to set strategic organizational initiatives and champion Umoja’s quality culture
• Establishing and monitoring quality and compliance goals and operational performance metrics to identify and drive continuous improvement initiatives and operational excellence
• Establishing and maturing consistent ways of working within the GMP QA organization and all relevant stakeholders (e.g., Manufacturing, Supply Chain, Facilities & Engineering, CMC, Regulatory, etc.) in alignment with a defined risk profile appropriate for applicable phases of development
• Establishing a functional budget and monitoring adherence to accomplish organizational objectives in alignment with company financial guidelines
• Monitoring, maturing, and continually improving components of Umoja’s Quality Management System relevant to GMP operations through compliance with, and practical…