Senior Specialist, Quality Assurance
Umoja Biopharma
$105,060 - $129,780 / year
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Description
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 Specialist, Quality Assurance to provide Quality Assurance oversight and subject matter expertise in support of new product introduction, and routine current Good Manufacturing Practice (cGMP) operations. This role partners closely with Manufacturing, Process Sciences, Engineering, Facilities, Quality Control, Supply Chain, Regulatory Affairs, and other functions to ensure operations are conducted in accordance with approved procedures, internal quality standards, and applicable regulatory requirements. The Senior Specialist, Quality Assurance independently provides quality guidance, reviews and approves GMP documentation, supports investigations and change implementation, provides on-the-floor QA oversight, and contributes to the development and continuous improvement of site quality systems.
CORE ACCOUNTABILITIES
Specific responsibilities include:
- Independently provides Quality oversight and direction in support of task execution during site start-up and routine cGMP (current Good Manufacturing Practice) operations.
- Interfaces with other departments (e.g., Supply Chain, MSAT, Facilities, Validation, Manufacturing, and Quality Control) to ensure compliance with all applicable procedures, policies, and standards.
- Provides strategic quality input and subject matter expertise on implementation of site material controls.
- Reviews and approves material specifications and performs material disposition.
- Reviews and approves Master Batch Records, work instructions, SOPs, specifications, and other controlled documents related to operations and other cGMP activities as needed
- Reviews and approves SOPs, work instructions, product specifications, and other controlled documents related to operations and other cGMP activities as needed.
- Reviews and approves Deviations, CAPAs (Corrective and Preventative Actions), and Change Controls.
- Develops, trends, and manages key performance indicators and metrics related to Umoja Quality Systems.
- Assists in the design and/or implementation of processes for batch record review and product disposition.
- Partners directly with other functional areas by providing Quality-on-the-floor oversight and real-time support.
- Other duties as assigned.
The successful candidate will have:
- Bachelor's degree in Biochemistry, Molecular and Cellular Biology, Immunology, Biology, or a related life sciences or technical discipline.
- Minimum of 8+ years of experience in an FDA-regulated industry.
- Equivalent combinations of education, training, and relevant experience may be considered.
- Strong working knowledge of cGMP requirements and Quality Systems.
- Ability to independently assess quality and compliance risks and make sound, timely decisions.
- Ability to provide effective on-the-floor Quality support in a dynamic manufacturing environment.
- Strong understanding of good documentation practices and data-integrity principles.
- Ability to interpret and apply regulatory requirements in a practical and risk-based manner.
- Strong technical writing, investigation, analytical, and problem-solving skills.
- Strong interpersonal and cross-functional collaboration skills.
- Ability to appropriately challenge decisions while maintaining productive working relationships.
- Strong verbal and written communication skills.
Preferred Qualifications:
- Experience supporting viral-vector, cell-therapy, gene-therapy, biologics, or aseptic manufacturing operations.
- Experience with batch record review and product disposition.
- Knowledge of FDA regulations, EU GMP requirements, ICH guidelines, and applicable industry standards.
- Previous experience participating in cGMP audits and inspections.
Physical Requirements:
- Ability to gown aseptically and work in a Clean Room environment, if required.
- Ability to work while gowned for extended periods of time, if required.
- Ability to stand for extended periods of time to fulfill on-the-floor Quality duties, if required.
- 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 nights and weekends as needed.
- Ability to primarily work onsite, working remotely when appropriate.
Salary Range: $105,060 - $129,780
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.
About this role
Umoja Biopharma is building novel immunotherapies for cancer treatment and needs a Senior Specialist, Quality Assurance to anchor quality operations at its Louisville facility. You would own QA oversight during site start-up and ongoing cGMP manufacturing, working independently to review and approve critical documentation—batch records, SOPs, specifications, deviations, and change controls. This is a hands-on role that requires you to be present on the manufacturing floor, partnering across Manufacturing, Process Sciences, Regulatory Affairs, Supply Chain, and other functions to ensure compliance with FDA regulations and internal quality standards.
The position calls for eight or more years in FDA-regulated industries and a strong foundation in cGMP and quality systems. You'll need solid technical writing and investigation skills, the ability to assess quality risks independently, and the judgment to make timely decisions in a dynamic environment. Experience with cell therapy, viral-vector, or biologics manufacturing is preferred but not required; what matters most is your ability to interpret regulatory requirements practically, challenge decisions constructively, and communicate clearly across functions.
The role is in-office in Louisville, Kentucky, with occasional evening and weekend work. You'll need to be comfortable gowning for extended periods in a clean room, standing for length, and handling lab equipment and materials. The salary range is $105,060 to $129,780, and benefits include medical, dental, and vision coverage, a 401k with a 100% match on the first 4% of deferrals, paid time off, commuter benefits, and a cell phone stipend.
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Pay for this role
$105,060 to $129,780 per year
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