Senior Specialist, Quality Assurance, External Supplier

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 We are 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 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 aspects of the vendor management program. 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 GxP operations. CORE ACCOUNTABILITIES Specific responsibilities include:

• Works effectively and leads cross-functionally across Umoja to fulfill Vendor QA oversight and performance monitoring responsibilities.
• Manages the GMP supplier notification and change process with limited Management oversight and direction, working with cross-functional subject matter experts (SMEs) to assess and document impact.
• Manages the Supplier Corrective Action Record (SCAR) process and material defect management process with limited Management oversight and direction.
• Performs vendor recertification events for identified vendors with limited Management oversight and direction in collaboration with cross-functional SME.
• Provide support for the Vendor Management program, as needed.
• Executes controlled document archival process, when required.
• Authors, reviews, and/or approves Standard Operating Procedures (SOPs) and other controlled documents as Quality Assurance representative.
• Provide additional support within the Quality Assurance organization to provide Quality oversight and support to GxP tasks and programs, when needed.
• Support organizations outside of Quality, if needed, to accomplish facility objectives and routine operations.
• Other duties, as assigned

The successful candidate will have:

• Bachelor’s degree in Biochemistry, Molecular and Cellular Biology, Immunology, Biology, or other life science with a minimum of 8+ years of experience in an FDA regulated industry, or similar combination of education and experience.
• Extensive experience with quality management systems and vendor management.
• Experience participating in external (vendor) audits.
• Knowledge of relevant pharmaceutical regulations and regulatory guidance.
• Understanding of, and ability to apply, risk management principles and philosophy within the quality system in support of Phase 1/first-in-human products/programs.
• Strong communication and organizational skills and a passion for teamwork.
• Ability to work effectively and efficiently in a collaborative manner across multiple functional areas and vendors with minimal supervision.
• Previous experience in a Quality organization supporting a cGMP biopharmaceutical manufacturing facility startup and/or operations environment.
• Experience leading and implementing operational excellence initiatives and process simplification.

Preferred Qualifications:

• Previous experience with a vendor management program in a current Good Manufacturing Practice (cGMP) environment.
• Experience in cGMP cell and gene therapy manufacturing and/or testing facility.

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, including standing for extended periods of time.
• Ability to sit in office setting for extended periods of time.
• Ability to work occasional nights and weekends as needed.
• Ability to work onsite 5 days/week

Salary Range: $105,100 - $130,000

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. Apply tot his job Apply To this Job