Umoja Biopharma · 1 day ago
Senior Specialist, Quality Assurance
Louisville, Colorado, United States
Full-time
Onsite
Mid, Senior Level
$105K/yr - $130K/yr
7+ years expUmoja Biopharma is an industry-leading biotech focused on transforming the treatment of cancer with a novel integrated immunotherapy platform. They are seeking a highly motivated individual to join their Quality Assurance team, playing a key role in quality systems and GMP operations. The role involves collaboration with cross-functional teams to ensure quality requirements are met and continuous improvement of quality systems.
BiopharmaBiotechnology
Responsibilities
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
Qualification
Required
Bachelor's degree in Engineering, Biochemistry, Molecular and Cellular Biology, Immunology, Biology, or other life science with minimum of 7 years of work experience in GMP biotech or pharma setting. Equivalent combination of education and experience will be considered
Knowledge and understanding of regulatory governing bodies, phase-specific cGMP requirements, guidance documents, laws, and regulations, and how to practically apply these in GMP manufacturing environment to ensure quality and compliance
Phase-appropriate cGMP knowledge, experience, and effective and consistent risk-based approach to quality system establishment, execution, and maturation
Extensive experience with quality oversight, review, and approval of investigations/deviations, CAPA, and change control using a phase-appropriate approach
Experience with, and proficiency in, product complaints processes and performing associated investigations
Experience using and maturing electronic quality systems in support of internal GMP manufacturing operations (e.g., Veeva. Trackwise)
Strong understanding of unit operations and processes supporting GMP manufacturing operations in an aseptic environment
Strong history of successfully leading and implementing operational excellence initiatives and process simplification related to Quality Systems
Proficiency in developing effective, concise training materials and delivering Instructor-Led training to audiences varying in size
Independent and risk-based decision-making capability with clear understanding of decision-making impact in dynamic environment
Ability to work and communicate effectively and efficiently in a collaborative manner across multiple functional areas
Previous experience participating in partner audits and health authority inspections
Experience with material and product disposition to drive at material disposition impact assessment and support disposition-related activities
Preferred
Experience in cGMP cell and gene therapy manufacturing across all phases of development (i.e., Phase 1 through commercial)
Experience with Lean and/or Six Sigma quality system methodologies
Benefits
Medical, Dental, and Vision plans
401k plan through Fidelity, with a 100% match up to their first 4% deferral
Generous Paid Time Off policy
Employee commuter benefits
Cell phone stipend
Company
Umoja Biopharma
Umoja Biopharma is a biopharmaceutical company developing next-generation immunotherapies intended to combat cancer.
51-200 employees
H1B Sponsorship
Umoja Biopharma has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
2022 (2)
Funding
Current Stage
Growth StageTotal Funding
$363MKey Investors
DCVC Bio
2025-01-14Series C· $100M
2021-06-15Series B· $210M
2020-11-18Series A· $53M
Leadership Team
Ryan Crisman
Co-Founder and Chief Technology Officer
Recent News
BioWorld Financial Watch
2025-12-29
Company data provided by crunchbase