Umoja Biopharma · 5 hours ago
Senior Director, GMP Quality Assurance
Louisville, CO
Contract
Onsite
Director/Executive
$234K/yr - $289K/yr
15+ years expUmoja Biopharma is an industry-leading biotech focused on transforming the treatment of cancer with a novel integrated immunotherapy platform. The Sr. Director, GMP Quality Assurance is responsible for overseeing all quality assurance operations related to Good Manufacturing Practices, leading a GMP QA organization, and collaborating with various stakeholders to ensure product quality and compliance throughout the product lifecycle.
BiopharmaBiotechnology
Responsibilities
Leading the GMP Quality Assurance (GMP QA) function at Umoja in support of Umoja’s multi-product, multi-jurisdiction, multi-partner portfolio through all phases of development (e.g., Phase 1, Pivotal, PPQ, commercial launch, etc.)
Building, mentoring, and leading a high-performing GMP QA team, fostering a culture of quality, accountability, collaboration, and organizational flexibility & adaptability within the team and across the organization in alignment with Umoja’s values & principles and Umoja’s quality culture
Developing, implementing, and executing a comprehensive organizational vision and strategy in alignment with Quality organization, site, and corporate goals & objectives
Active engagement in Umoja’s Quality Leadership Team (QLT) to set strategic organizational initiatives and champion Umoja’s quality culture
Establishing and monitoring quality and compliance goals and operational performance metrics to identify and drive continuous improvement initiatives and operational excellence
Establishing and maturing consistent ways of working within the GMP QA organization and all relevant stakeholders (e.g., Manufacturing, Supply Chain, Facilities & Engineering, CMC, Regulatory, etc.) in alignment with a defined risk profile appropriate for applicable phases of development
Establishing a functional budget and monitoring adherence to accomplish organizational objectives in alignment with company financial guidelines
Monitoring, maturing, and continually improving components of Umoja’s Quality Management System relevant to GMP operations through compliance with, and practical application of, phase-appropriate global GMPs (e.g., FDA, EMA, MHRA, PMDA, ICH, etc.), data integrity standards, Health Authority expectations & requirements, applicable laws, and company policies
Overseeing the development, implementation, and maintenance of GMP QA policies, quality agreements, SOPs, and quality systems processes and workflows to disposition material & product and effectively manage quality records and events (e.g., deviations, CAPA, change control, product complaints, etc.)
Overseeing the selection, qualification, and ongoing monitoring of all GMP vendors, including contract manufacturers, suppliers, and testing laboratories, ensuring vendor compliance with contractual obligations, quality agreements, and regulatory requirements
Overseeing a phase-appropriate approach to Quality Management Review, ensuring applicable and meaningful metrics are evaluated to assess control and identify areas for continual improvement
Ensuring effective quality risk management practices are in place, including identification, communication, assessment, and resolution of quality-related risks
Providing strategic support and leadership review of CMC-related sections within regulatory submissions in support of US and ex-US jurisdictional filings in close collaboration with cross-functional teams
Leading and supporting preparation for, and execution of, partner audits and health authority inspections, overseeing closure of appropriate responses and other actions per established timelines
Representing GMP QA in regulatory inspections, partner audits, due diligence activities, and health authority communications
Ensuring all product complaints are received, evaluated, and investigated, and closed in accordance with internal procedures and health authority expectations
Ensuring appropriate data integrity controls, systems, and processes are in place and function as required in support of GMP processes
Reviewing and approving audit reports, CAPA plans, and follow-up actions to ensure effective resolution of related quality events
Providing expert guidance on GMP compliance and escalating critical quality events, nonconformances, and compliance issues to cross-functional teams and senior management
Providing QA leadership, direction, and effective cross-functional communication in support of product recall events
Representing the QA and/or Quality function on various Umoja senior leadership governance committees and leadership forums, where appropriate
Monitoring industry trends and emerging best practices to innovate and proactively enhance quality processes
Other duties as required
Qualification
Required
BS/BA degree (or equivalent) in life sciences with a minimum of 15 years of progressive and extensive quality and compliance background in pharma/biotech across all phases of development (e.g., Phase 1, Pivotal, PPQ, commercial launch, etc.)
Minimum of 8 years management (direct or matrix) experience with proven track record of building & developing highly collaborative, effective, and successful individuals, teams, & organizations
Strong patient-focused and quality culture mindset rooted in collaboration and continual improvement
Proven track record of effective and collaborative organizational leadership, setting and executing a strategic organizational vision, and developing leaders and organizations in alignment with company and individual goals and objectives
Extensive experience with comprehensive GMP quality assurance organizations, processes, and systems supporting internal manufacturing operations within a multi-product GMP manufacturing facility
Extensive experience with designing, implementing, and maturing effective, efficient, and appropriately risk-based quality systems suitable for intended use across all phases of development
Strong understanding of health authority submission dossier composition and effective CMC section strategy & content from INDs through BLAs (or equivalent) across multiple jurisdictions
Experience with health authority interactions, site inspections, and regulatory submissions
Experience defining, implementing, and maturing six sigma quality systems throughout the product lifecycle
Strong understanding of tech transfer processes and standards
Proficiency in making practical, risk-based decisions in alignment with quality & compliance requirements and expectations in a dynamic environment
Extensive experience in providing QA support and oversight of GMP electronic systems implementation and execution (e.g., SAP, Veeva, BMRAM, etc.)
Extensive experience with novel therapies progressing from early phase to late phase to commercial
Preferred
Extensive Quality organization experience within cell and/or gene therapy across all phases of development
Experience with various GMP electronic systems (e.g., BMRAM, Veeva, LIMS, etc.)
Experience designing, implementing, and/or maturing six sigma quality systems and Lean 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