Senior Specialist, Quality Assurance

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.

We at Umoja believe in the importance of stories; we are looking for great people to join our team to help us create more stories for ourselves, for you, and most importantly for patients and their families.

Umoja Biopharma – Your Body. Your Hope. Your Cure.

Umoja Biopharma is seeking a highly motivated individual to join our growing Quality Assurance team. This individual will play a key role in Umoja’s state-of-the-art lentiviral vector development and internal GMP manufacturing facility, The CLIMB in Louisville, CO. In collaboration with Quality management and multiple functions, this individual will execute, mature, and drive continuous improvement of key quality systems and associated records (e.g., deviations, CAPA, change controls, product complaints, etc.)

utilizing a phase appropriate, risk-based approach as the Quality Assurance Subject Matter Expert (SME). Additionally, this role will collaborate with cross-functional teams to ensure quality requirements are defined, clearly communicated and understood, and met as part of routine and advancing GMP operations. This is a full-time onsite role based out of our Louisville, CO GMP manufacturing facility.

• Effectively contributing within a high-performing GMP QA team, fostering a culture of quality, accountability, collaboration, and organizational flexibility & adaptability in alignment with Umoja’s values & principles and Umoja’s quality culture
• Independently provides Quality Assurance oversight and direction in support of Quality Record execution (Deviations, CAPAs (Corrective and Preventive Actions), Change Controls, and product complaints) in support of internal GMP manufacturing operations
• Reviewing and approving Deviations, CAPAs, and Change Controls and other Quality Records
• Performing assessments and investigations related to product complaints in close coordination with Quality management
• Collaborating closely with key stakeholders and Quality management to define key performance indicators and metrics for quality systems performance, identifying and driving continual improvement
• Developing visual management tools and other business processes to increase effectiveness and efficiency of quality record management and execution in compliance with approved procedures and standards
• Developing and delivering training materials to key stakeholders on core quality systems
• Identifying and driving updates to electronic quality systems, where necessary, to increase effectiveness and efficiency of system usage and align with quality system continual improvement
• Compiling and arranging applicable metrics and data in support of Quality Management Review
• Providing support during preparation and execution of audits and inspections
• Supporting continuous improvement and maturation of core Quality Systems
• Interfacing and effectively collaborating and communicating with other departments (e.g., Supply Chain, Process Sciences, Facilities, Validation, Manufacturing, and Quality Control) to ensure compliance with all applicable procedures, policies, and standards
• Owning, reviewing and approving SOPs, work instructions, and other controlled documents related to operations and other cGMP activities
• May assist with material and product disposition, as needed.
• Other duties as assigned

• Bachelor’s…