Sr Director/Director, Quality Operations

2 days ago


Bothell, United States Immunome Full time

Company Overview Immunome is a clinical-stage targeted oncology company committed to developing first- and best-in-class targeted therapies designed to improve outcomes for cancer patients. We are advancing an innovative portfolio of therapeutics, drawing on leadership that previously played key roles in the design, development, and commercialization of cutting-edge targeted cancer therapies, including antibody-drug conjugate therapies (ADCs.) In addition to a portfolio of discovery-stage ADCs, our pipeline includes AL102, a gamma secretase inhibitor which is currently in a Phase 3 trial for treatment of desmoid tumors, as well as IM-1021, a ROR1 ADC, and IM-3050, a FAP-targeted radioligand, both of which are the subject of INDs expected to be submitted in the first quarter of 2025. Position Overview The Senior Director/Director of Quality Operations will play a pivotal role in ensuring the highest standards of quality and compliance are executed across all aspects of operations. This position collaborates with internal and external stakeholders to ensure product quality and regulatory compliance throughout all stages of the product lifecycle, from development to commercialization. The Director/Senior Director of Quality Operations is responsible for developing and leading quality programs for both commercial and clinical manufacturing operations, ensuring compliance with global regulatory standards. This role interacts with executive leadership to communicate quality initiatives, issues, and resource requirements, ensuring alignment with corporate compliance goals. The position oversees quality assurance (QA) activities across multiple functional areas and manufacturing sites, leads internal and external audits, and drives continuous improvement in quality systems. Responsibilities Quality Operations Oversee the drug substance, drug product, packaging/labeling/serialization, third party logistics. Review and approve specifications affecting product quality and oversee the development of master batch records, process and method validation/protocol reports and other technical documents created to support all stages of the product lifecycle, from development to commercialization. Disposition early phase and commercial batches. Ensure effective CAPA management, change controls, deviations, and other GMP-related processes are followed during manufacturing and testing of products. Interact with manufacturing, clinical, or other functional areas that impact quality operations and provide support as needed. Perform risk assessments and implement appropriate quality and process controls to ensure proper oversight of production activities. Support vendor qualification program and monitor vendor performance. Prompt communication to management of potential compliance issues. Participate in internal and external project team meetings. Documentation and Record Control Perform periodic reviews and revisions of SOPs, policies, and Quality Agreements to align with regulatory updates and business needs. Establish, review and/or approve Quality Agreements and ensure they are properly stored and managed. Regulatory Compliance and Inspection Readiness Ensure external parties are inspection-ready, in compliance with regulatory requirements, and prepared for GMP audits or inspections from FDA or other international regulatory bodies. Collaborate with regulatory affairs and cross-functional teams to support regulatory submissions, including providing necessary documentation and ensuring compliance with filing requirements. Support site preparation for regulatory inspections including personnel preparation and training Participate in Quality Management Review meetings. Assist in updating CMC sections of regulatory and quality documents Operational Leadership and Continuous Improvement Drive continuous improvement initiatives across quality operations to enhance operational efficiency, reduce risk, and improve product quality. Provide strategic direction and hands-on leadership for operations teams, ensuring alignment with business goals and regulatory demands. Develop and implement metrics to monitor and report on the performance of Operations, identifying areas for improvement and ensuring corrective actions are implemented. Promote a strong Quality culture within the organization. Identify compliance risks and be a part of the solution through ownership and collaboration. Team Leadership and Development Mentor, coach, and develop a high-performing quality team to support the growth of the organization. Set performance objectives for direct reports and manage their development through regular performance evaluations. Qualifications Education and Experience Bachelor’s degree in life sciences, chemistry, engineering, or related field; advanced degree (MS, PhD, MBA) preferred. Minimum of 15 years of experience in quality assurance, quality systems and/or quality operations within the pharmaceutical, biotechnology, or life sciences industries. A minimum of 5 years of leadership experience is required. Knowledge and Skills Proven experience in managing GMP operations, QMS, including vendor management and CMO oversight. Strong knowledge of FDA, EMA, ICH, and other global regulatory guidelines and their application to Quality Operations. Experience supporting clinical and commercial stage programs, with a strong understanding of the product lifecycle from development through to commercialization. Strong project management, organizational, and leadership skills with the ability to multitask and prioritize in a fast-paced environment. Excellent verbal and written communication skills, with the ability to collaborate effectively across functions and at all levels of the organization. Demonstrated ability to lead cross-functional teams and manage external vendors and stakeholders. Proficiency in using electronic QMS platforms (e.g., MasterControl, TrackWise, Dot Compliance) and Microsoft Office (Word, Excel, PowerPoint). Strategic thinking with a proactive approach to problem-solving and process improvement. Experienced with biologics and small molecule manufacturing processes. Travel Position may require domestic and international travel (up to 25%). E/E/O Immunome, Inc. is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. #J-18808-Ljbffr



  • Bothell, United States Immunome Full time

    Company Overview Immunome is a clinical-stage targeted oncology company committed to developing first- and best-in-class targeted therapies designed to improve outcomes for cancer patients. We are advancing an innovative portfolio of therapeutics, drawing on leadership that previously played key roles in the design, development, and commercialization of...


  • Bothell, Washington, United States Immunome Full time

    Job Title: Director of Quality OperationsImmunome is a clinical-stage targeted oncology company committed to developing innovative therapies for cancer patients. We are advancing a portfolio of therapeutics, drawing on leadership that previously played key roles in the design, development, and commercialization of targeted cancer therapies.Job SummaryThe...


  • Bothell, Washington, United States Immunome Full time

    Job Title: Senior Director/Director of Quality SystemsImmunome is a clinical-stage targeted oncology company committed to developing innovative therapies for cancer patients. We are advancing a portfolio of therapeutics, drawing on leadership that previously played key roles in the design, development, and commercialization of cutting-edge targeted cancer...


  • Bothell, Washington, United States Immunome Full time

    Job Title: Senior Director/Director, Quality SystemsImmunome is a clinical-stage targeted oncology company committed to developing innovative therapies for cancer patients. We are advancing a portfolio of therapeutics, drawing on leadership experience in the design, development, and commercialization of targeted cancer therapies.Job Summary:The Senior...


  • Bothell, Washington, United States ESFM Full time

    Job Title: Director of Unit OperationsESFM is a leading provider of integrated facilities management (IFM) solutions, delivering innovative and sustainable environments for clients across various industries.The Director of Unit Operations will be responsible for planning, organizing, and controlling the functions and activities of the department, ensuring...


  • Bothell, Washington, United States Providence Full time

    Job Title: Senior Director of Quality and SafetyProvidence is seeking a highly skilled and experienced Senior Director of Quality and Safety to lead our quality improvement initiatives in the North Puget Sound Service Area.Key Responsibilities:Provide strategic direction and leadership for quality improvement initiatives across the service area.Develop and...


  • Bothell, Washington, United States Caliber Sourcing Full time

    Job Title: Associate Director, Operational ExcellenceAbout the Role: We are seeking a highly skilled and experienced Associate Director, Operational Excellence to join our team. As a key member of our organization, you will be responsible for driving the development and implementation of a world-class continuous improvement program. This will involve...


  • Bothell, United States Bristol-Myers Squibb Full time

    The Associate Director, Compliance and Investigations, leads a team that provides compliance and investigations support to the Bothell Cell Therapy Manufacturing Facility. The Associate Director will build a team and establish processes for investiga Director, Compliance, Associate, Quality Assurance, Process Engineer, Operations, Business Services


  • Bothell, Washington, United States Immunome Inc Full time

    Job Title: Associate Director/Director, Translational BiomarkersImmunome Inc. is a clinical-stage targeted oncology company dedicated to developing innovative therapies for cancer patients. We are seeking an experienced Associate Director/Director, Translational Biomarkers to join our team.Job Summary:The Associate Director/Director, Translational Biomarkers...

  • Director of Pathology

    4 weeks ago


    Bothell, Washington, United States Immunome Full time

    Job Title: Director, PathologyImmunome is a clinical-stage targeted oncology company dedicated to developing innovative therapies for cancer patients. We are seeking a highly skilled Director, Pathology to join our team and contribute to the development of our pipeline.Job SummaryThe Director, Pathology will be responsible for developing and implementing...

  • Creative Director

    1 month ago


    Bothell, Washington, United States Metasys Technologies, Inc. Full time

    Job Title: Creative DirectorWe are seeking a highly skilled Creative Director to lead our design team at Metasys Technologies, Inc.About the RoleThis is a 3-year contract position based in Bothell, WA. As a Creative Director, you will be responsible for overseeing the development of innovative digital experiences that meet the needs of our clients.Key...


  • Bothell, Washington, United States 24 Hour Fitness, INC. Full time

    Job SummaryThe Fitness Program Director will lead the development and implementation of comprehensive fitness programs for clients, embodying 24 Hour Fitness's core values. This role requires a strong focus on member retention, client acquisition, and supporting the Fitness Coach Team. The ideal candidate will have excellent communication skills, be able to...

  • Director of Pathology

    3 weeks ago


    Bothell, Washington, United States Immunome Full time

    Job Title: Director, PathologyImmunome is a clinical-stage targeted oncology company dedicated to developing innovative therapies for cancer patients. We are advancing a portfolio of therapeutics, leveraging expertise in targeted cancer therapies, including antibody-drug conjugate therapies (ADCs). Our pipeline includes AL102, a gamma secretase inhibitor in...


  • Bothell, United States MatchPoint Full time

    🚀 We’re Hiring! Director of Privileged Access Services (PAM) 🚀📍 Location: HYBRID (2 days onsite required – must live within 50 miles of one of these locations):- Collegeville, PA- Bothell, WA- New York City, NY- Tampa, FL- Groton, CTRate: $100-$110/ hr⏳ Duration: 3-Month Contract to HireLooking for indvidulas whom are in Director and VP...


  • Bothell, Washington, United States Bristol-Myers Squibb Full time

    Transforming Patients' Lives through ScienceAt Bristol Myers Squibb, we're committed to delivering innovative solutions that transform patients' lives. As an Associate Director, MSAT Cell Therapy Compliance and Investigations, you'll play a critical role in ensuring the highest standards of compliance and quality in our biopharmaceutical operations.Key...


  • Bothell, United States Terex Full time

    Job Description: Title:Director, Customer Service Operations, North America Reports to: Global VP Sales Transformation & Operations Location: Bothell, WA Travel: Up to 20% (domestic and international) About the Position The Director, Customer Service Operations plays a pivotal role within our Global Customer Experience team, providing essential leadership...


  • Bothell, United States Terex Full time

    Job Description: Title: Director, Customer Service Operations, North America Reports to: Global VP Sales Transformation & Operations Location: Bothell, WA Travel: Up to 20% (domestic and international) About the Position The Director, Customer Service Operations plays a pivotal role within our Global Customer Experience team, providing essential leadership...


  • Bothell, Washington, United States Greenpoint Technologies Full time

    Job Title: Senior Design Engineering DirectorGreenpoint Technologies is seeking a highly experienced Senior Design Engineering Director to lead our design engineering team. As a key member of our leadership team, you will be responsible for driving the development of our design engineering capabilities and ensuring the delivery of high-quality products to...


  • Bothell, Washington, United States AlienVault Full time

    Job Title: Associate Director CybersecurityAT&T is seeking an experienced Associate Director Cybersecurity to lead our Cybersecurity team. As a key member of our leadership team, you will be responsible for directing cyber security areas across products, services, infrastructure, networks, and/or applications while providing protection for AT&T, our...


  • Bothell, Washington, United States Seagen Full time

    Job Title: Associate Medical DirectorSeagen is a global biotechnology company dedicated to developing and commercializing transformative cancer medicines. As a leader in antibody-drug conjugate (ADC) technology, we are committed to improving the lives of cancer patients.Job Summary:This position is for an Associate Medical Director within the...