Senior Manager, Quality Assurance Operations

Umoja Biopharma is an industry-leading biotech 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 our core values and principles that support our overall mission and strongly invite applications from enthusiastic individuals who share our commitment and help position Umoja to deliver on our goals. 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. POSITION SUMMARY Umoja Biopharma is seeking a Senior Manager, Quality Assurance (QA) Operations to support GMP operations at Umoja’s state-of-the-art lentiviral vector development and manufacturing facility, The CLIMB, in Louisville, CO. This position delivers leadership and management oversight of the QA Operations team, which provides QA partnership and oversight of all GxP functions (e.g., Manufacturing, Supply Chain, Facilities, Engineering, etc.) at The CLIMB. This role is fully onsite at our Louisville, CO location 5 days/week. This role may require weekend, evening, or holiday work when necessary. CORE ACCOUNTABILITIES Specific responsibilities include: Exemplifying, role modeling, and maturing Umoja’s quality culture Managing, building, and maturing a high-performing, solution-oriented function that nurtures strong cross-functional working relationships Leading, managing, and supporting QA Operations to provide QA partnership and oversight (e.g., controlled documents, change controls, deviations, CAPAs, work orders, etc.) of GxP functions (e.g., Manufacturing, Supply Chain, Facilities, Engineering, etc.) at The CLIMB Supports QA Operations teams collaborative interactions with cross-functional partners in translating applicable laws, regulations, and guidance (e.g., FDA, ICH, EMA, etc.) into compliant & efficient internal procedures and ways of working in accordance with phase-appropriate cGMPs and effective quality risk management principles Engaging with key stakeholders and utilizing Operational Excellence principles and tools to drive continual improvement of the Umoja Quality Management System Championing Umoja QA’s “purposeful presence” initiative, ensuring productive and intentional QA partnership with cross-functional teams Overseeing disposition of product and incoming materials Advancing Umoja’s Quality Risk Management (QRM) program and associated processes Partnering with senior Quality management to develop a QA Operations functional strategy to achieve short-term and long-term organizational and company goals & objectives Translating functional area strategy into an efficient tactical execution plan that prioritizes functional workload Establishing, monitoring, and maturing key business performance metrics to facilitate continual improvement opportunity identification and execution. Developing and maintaining capacity and resource modeling tools for the QA Operations functions Development of QA Operations team through engaging, purposeful development planning and routine follow-up Representing QA Operations on cross-functional leadership and project teams Supporting the preparation of documents and sections for regulatory dossiers (e.g., briefing books, IND sections, BLA sections, etc.) Providing support for audits and inspections, where needed Providing additional Quality Assurance support and leadership, as needed The successful candidate will