Senior Manager, Quality Assurance Operations

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