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 have:
- Bachelor’s degree in Biochemistry, Molecular and Cellular Biology, Immunology, Biology, or other life science with minimum of 10+ years of work experience in an FDA regulated industry.
- Minimum of 4+ years of successful people management experience with demonstrated ability to build, develop, and lead a high-performing team.
- Advanced knowledge and understanding of regulatory governing bodies, requirements, and guidance documents, and how to practically apply these in a cGMP biopharmaceutical environment across different phases of product development
- Strong understanding of foundational Quality systems (e.g., audits/inspections, documentation, NC/CAPA, Quality Risk Management, etc.)
- Previous experience releasing product for clinical and/or commercial use
- Independent and risk-based decision-making capability with clear understanding of decision-making impact in dynamic GMP environment
- Ability to think and lead conceptually, strategically, and tactically, arriving at practical and pragmatic conclusions
- Ability to translate complex processes and competing priorities into a clear, actionable plan for execution
- Experience in cGMP cell and gene therapy manufacturing facility
Preferred Qualifications:
- Previous experience with audits and health authority inspections
- Previous experience providing QA oversight of sterile injectable product(s)
Physical Requirements:
- Ability to gown aseptically and work in a Clean Room environment
- Ability to work while gowned for extended periods of time
- Ability to stand for extended periods of time to fulfill on-the-floor Quality duties
- Use of laboratory equipment includes handling chemicals and biological materials
- Must have the ability to work around laboratories, manufacturing areas and equipment, and regularly lift 10-20 lbs. and periodically lift up to 50 lbs.
- Ability to work occasional evenings, holidays, and weekends as needed
Salary Range: $155,000 - $191,500
Benefits Offerings
Umoja Biopharma offers its employees competitive Medical, Dental, and Vision plans. Additionally, we offer Umojians access to a 401k plan through Fidelity, with a 100% match up to their first 4% deferral. Umoja also provides a generous Paid Time Off policy, employee commuter benefits, and cell phone stipend. For a full breakdown of our benefits offerings, please see the Benefits section of our website.
