Senior Manager, Quality Assurance Operations

Umoja Biopharma•Louisville, CO

1d•Onsite

About The Position

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.

Requirements

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

Nice To Haves

Previous experience with audits and health authority inspections
Previous experience providing QA oversight of sterile injectable product(s)

Responsibilities

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