Senior Director, GMP Quality Assurance - Louisville - Umoja BioPharma

Description

Umoja Biopharma is an industry-leading biotech with locations in Seattle, WA and Louisville, CO, focused on transforming the treatment of cancer with a novel integrated immunotherapy platform. Our vision is to develop off-the-shelf therapies capable of treating any tumor, any time. We are a diverse and growing team working in brand-new facilities in downtown Seattle, Washington and Louisville, Colorado, and we are looking for innovative thinkers who are excited by groundbreaking science and technology, and passionate about squaring up to the challenges inherent to cutting-edge drug development. We are committed to our core values and principles that support our overall mission and strongly invite applications from enthusiastic individuals who share our commitment and help position Umoja to deliver on our goals. We at Umoja believe in the importance of stories; we are looking for great people to join our team to help us create more stories for ourselves, for you, and most importantly for patients and their families.
Umoja Biopharma - Your Body. Your Hope. Your Cure.
POSITION SUMMARY
The Sr. Director, GMP Quality Assurance (GMP QA) is responsible for overseeing all quality assurance operations for Umoja related to Good Manufacturing Practices (GMPs) for Umoja's product portfolio across all phases of the product lifecycle. This senior leadership role will lead a GMP QA organization comprised of quality professionals supporting internal and external GMP manufacturing operations, quality systems, and oversight of GMP vendors. As a senior leader within the company and Quality organization, this role will provide strategic leadership and direction, collaborating across all relevant internal and external stakeholders (e.g., Manufacturing, Supply Chain, Facilities & Engineering, CMC, Regulatory, etc.) to develop high performing & collaborative teams and mature and execute a comprehensive functional vision in alignment with company and organizational goals. This role will oversee and direct the maturation and continual improvement of GMP quality systems and processes that assure product quality & patient safety in accordance with Umoja quality principles and compliance with applicable laws, regulations, industry Standards, and Health Authority requirements & expectations appropriate for applicable phases of the product lifecycle.
This role shall also serve as a member of the senior Quality Leadership Team to set and execute strategic initiatives, maintain and encourage a strong continual improvement mindset, and serve as a critical leader in establishing, maturing, and championing Umoja's quality culture.
This position is an on-site role based at Umoja's GMP manufacturing facility, The CLIMB, in Louisville, Colorado, and will report directly to the Head of Quality.
CORE ACCOUNTABILITIES
Specific responsibilities include:

• 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

The successful candidate will have:

• 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 Qualifications:

• 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

Physical Requirements:

• Ability to travel occasionally
• Ability to sit for prolonged periods of time
• Ability to gown-in to support and/or observe on-the-floor work (e.g., Manufacturing, Supply Chain, Facilities & Engineering, etc.)

Salary Range: $234,260 - $289,380
Benefits Offerings