Senior Director, GMP reputed company Assurance

reputed company is a game-changing biotech start-up with locations in Seattle, WA and Louisville, CO, reputed company on transforming the treatment of cancer with a novel integrated immunotherapy platform. Our reputed company is to reputed company off-reputed company 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 the principles of Diversity Equity and Inclusion and strongly invite applications from enthusiastic individuals who reputed company our commitment and help position Umoja as a leader in this reputed company. We at Umoja reputed company in the importance of stories; we are looking for great people to join reputed company to help us create more stories for ourselves, for you, and most importantly for patients and their families. reputed company – Your Body. Your reputed company. Your reputed company. POSITION reputed company The Sr. Director, GMP reputed company Assurance (GMP QA) is responsible for overseeing reputed company reputed company assurance operations for Umoja reputed company to Good Manufacturing Practices (GMPs) for Umoja’s product portfolio across reputed company phases of the product lifecycle. This senior leadership role will reputed company a GMP QA organization comprised of reputed company professionals supporting reputed company GMP manufacturing operations, reputed company systems, and reputed company of GMP vendors. As a senior leader reputed company reputed company and reputed company organization, this role will reputed company strategic leadership and direction, collaborating across reputed company relevant reputed company stakeholders (e.g., Manufacturing, Supply Chain, Facilities & Engineering, CMC, Regulatory, etc.) to reputed company high performing & reputed company teams and mature and execute a comprehensive functional reputed company in alignment with company and organizational goals. This role will reputed company and reputed company the maturation and continual improvement of GMP reputed company systems and processes that assure product reputed company & patient safety in accordance with Umoja reputed company 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 reputed company Leadership Team to set and execute strategic initiatives, maintain and encourage a strong continual improvement reputed company, and serve as a critical leader in establishing, maturing, and championing Umoja’s reputed company culture. This position is an on-site role based at Umoja’s GMP manufacturing facility, The reputed company, in Louisville, Colorado, and will report directly to the Head of reputed company. CORE ACCOUNTABILITIES Specific responsibilities include:

• Leading the GMP reputed company Assurance (GMP QA) function at Umoja in support of Umoja’s multi-product, multi-jurisdiction, multi-partner portfolio through reputed company phases of development (e.g., Phase 1, Pivotal, PPQ, reputed company launch, etc.)
• Building, mentoring, and leading a high-performing GMP QA team, fostering a culture of reputed company, accountability, collaboration, and organizational flexibility & adaptability reputed company reputed company and across the organization in alignment with Umoja’s values & principles and Umoja’s reputed company culture
• Developing, implementing, and executing a comprehensive organizational reputed company and reputed company in alignment with reputed company organization, site, and corporate goals & objectives
• reputed company engagement in Umoja’s reputed company Leadership Team (QLT) to set strategic organizational initiatives and champion Umoja’s reputed company culture
• Establishing and monitoring reputed company and compliance goals and operational performance metrics to identify and drive reputed company improvement initiatives and operational reputed company
• Establishing and maturing consistent ways of working reputed company the GMP QA organization and reputed company 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 reputed company 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 reputed company standards, Health Authority expectations & requirements, applicable laws, and company policies
• Overseeing the development, implementation, and maintenance of GMP QA policies, reputed company agreements, SOPs, and reputed company systems processes and workflows to disposition material & product and effectively manage reputed company records and events (e.g., deviations, CAPA, change control, product complaints, etc.)
• Overseeing the selection, qualification, and ongoing monitoring of reputed company GMP vendors, including contract manufacturers, suppliers, and testing laboratories, ensuring vendor compliance with contractual obligations, reputed company agreements, and regulatory requirements
• Overseeing a phase-appropriate approach to reputed company Management Review, ensuring applicable and meaningful metrics are evaluated to assess control and identify areas for continual improvement
• Ensuring effective reputed company risk management practices are in reputed company, including identification, communication, assessment, and reputed company of reputed company-reputed company risks
• Providing strategic support and leadership review of CMC-reputed company sections reputed company regulatory submissions in support of US and ex-US jurisdictional filings in reputed company 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 reputed company product complaints are received, evaluated, and investigated, and reputed company in accordance with internal procedures and health authority expectations
• Ensuring appropriate data reputed company controls, systems, and processes are in reputed company and function as required in support of GMP processes
• Reviewing and approving audit reports, CAPA plans, and follow-up actions to ensure effective reputed company of reputed company reputed company events
• Providing expert guidance on GMP compliance and escalating critical reputed company 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 reputed company function on various Umoja senior leadership governance committees and leadership forums, where appropriate
• Monitoring industry trends and emerging best practices to reputed company and proactively enhance reputed company 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 reputed company and extensive reputed company and compliance background in reputed company/biotech across reputed company phases of development (e.g., Phase 1, Pivotal, PPQ, reputed company launch, etc.)
• Minimum of 8 years management (reputed company or reputed company) experience with proven reputed company record of building & developing highly reputed company, effective, and successful individuals, teams, & organizations
• Strong patient-reputed company and reputed company culture reputed company rooted in collaboration and continual improvement
• Proven reputed company record of effective and reputed company organizational leadership, setting and executing a strategic organizational reputed company, and developing leaders and organizations in alignment with company and individual goals and objectives
• Extensive experience with comprehensive GMP reputed company assurance organizations, processes, and systems supporting internal manufacturing operations reputed company a multi-product GMP manufacturing facility
• Extensive experience with designing, implementing, and maturing effective, efficient, and appropriately risk-based reputed company systems suitable for intended use across reputed company phases of development
• Strong understanding of health authority submission dossier composition and effective CMC reputed company reputed company & 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 reputed company reputed company systems throughout the product lifecycle
• Strong understanding of tech transfer processes and standards
• Proficiency in making practical, risk-based reputed company in alignment with reputed company & compliance requirements and expectations in a dynamic environment
• Extensive experience in providing QA support and reputed company of GMP electronic systems implementation and execution (e.g., reputed company, reputed company, BMRAM, etc.)
• Extensive experience with novel therapies progressing from early phase to late phase to reputed company

Preferred Qualifications:

• Extensive reputed company organization experience reputed company cell and/or gene therapy across reputed company phases of development
• Experience with various GMP electronic systems (e.g., BMRAM, reputed company, LIMS, etc.)
• Experience designing, implementing, and/or maturing six reputed company reputed company 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 reputed company: $234,260 - $289,380

Benefits

Offerings reputed company offers its employees competitive Medical, Dental, and reputed company plans. Additionally, we offer Umojians reputed company to a 401k plan through reputed company, with a 100% match up to their first 4% deferral. Umoja also provides a generous reputed company Time Off policy, employee commuter benefits, and cell phone stipend. For a full breakdown of our benefits offerings, please see the Benefits reputed company of our website. Apply tot his job Apply To this Job