Senior Specialist, Quality Assurance

POSITION SUMMARY

Umoja Biopharma is 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 internal GMP 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 quality systems and associated records (e.g., deviations, CAPA, change controls, product complaints, etc.) utilizing a phase appropriate, risk-based approach as the Quality Assurance Subject Matter Expert (SME).  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 GMP operations.

This is a full-time onsite role based out of our Louisville, CO GMP manufacturing facility.

CORE ACCOUNTABILITIES

Specific responsibilities include:  

• 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

The successful candidate will have:

• 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 Qualifications:  

• 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

Physical Requirements:  

• Ability to gown aseptically and work in a Clean Room environment
• 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 weekends or evenings as needed

Salary: $105,060 - $142,140