Sr Director/Director, Quality Operations

2 weeks 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, 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, United States Providence Careers Full time

    Description THE ROLE The Senior Director provides vision and leadership throughout the North Puget Sound Service Area for continuous improvement of clinical and service quality outcomes; designs, implements and maintains systems ensuring integration of quality support across the Service Area leading to improved health outcomes; integrates...


  • Bothell, WA, United States Providence Full time

    The Senior Director provides vision and leadership throughout the North Puget Sound Service Area for continuous improvement of clinical and service quality outcomes; designs, implements and maintains systems ensuring integration of quality support across the Service Area leading to improved health outcomes; integrates and promotes patient safety in...


  • 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 Evergreen Academy Full time

    Lead Enrollment Director Evergreen Academy (#1501), 16017 118th Place NE, Bothell, Washington, United States of America ● Seattle, WA, USA Req #8434 ...


  • 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...


  • Bothell, United States Redwood Family Care Network Full time

    Job DescriptionJob DescriptionJOB TITLE: Financial Services DirectorLocation: Everett, WA          CLASSIFICATION: Salary       DAYS/HOURS: M-F 8:00 -5:00pm Salary: $85,000 - $95,000  Are you looking for a career opportunity or change? Do you enjoy making a positive, long-lasting impact in people’s lives? If you said YES, then you may be who we...


  • 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 MatchPoint Full time

    Job Title: Director of Privileged Access ServicesJob Summary:We are seeking a highly experienced Director of Privileged Access Services to lead our PAM strategy, roadmap, and operations. As a key member of our team, you will be responsible for innovating and implementing solutions to manage and secure privileged accounts across various environments.Key...


  • Bothell, United States Futran Solutions Full time

    Job Description: PURPOSE AND SCOPE OF POSITION: This position reports into the Quality Assurance department and is responsible for assisting with the implementation and management of BMS's GMP Data Governance and Data Integrity program at the Bothell, WA manufacturing facility. REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities:Education: BS or higher...


  • Bothell, Washington, United States Terex Full time

    Job Summary: We are seeking a highly skilled and experienced Director, Customer Service Operations to lead our North America Customer Service team. The successful candidate will be responsible for overseeing the day-to-day operations of the Customer Service department, including call center activities, case management, and order processing. Key...


  • Bothell, United States Redwood Family Care Network Full time

    Job DescriptionJob DescriptionSupported Living Services - Quality Assurance Manager-EverettSalary: $70,000Schedule: M-F, 8:30AM – 5:00 PM/ On-CallSUMMARY: Will oversee the Quality Assurance Team. Ensure all QA’s are completed on a monthly basis. Support Quality Assurance team and Residential team in the field, train staff when needed, and support with...


  • Bothell, Washington, United States Immunome Full time

    Immunome is a clinical-stage targeted oncology company dedicated to developing innovative therapies for cancer patients. We are advancing a portfolio of therapeutics, drawing on leadership with expertise in targeted cancer therapies. The Associate Director for Biostatistics will provide critical statistical support to clinical studies, collaborating closely...


  • Bothell, United States National Black MBA Association Full time

    Job Title: Senior Director, Hardware Engineering Leader Ultrasound Senior Director, Hardware Engineering Ultrasound (Bothell, WA) The Global Hardware Engineering Leader defines and drives the technical direction for our Hardware Engineering group within the Ultrasound business and manages the overall capabilities of the department to ensure that business...


  • Bothell, United States Philips International Full time

    Senior Director, Hardware Engineering Leader UltrasoundSenior Director, Hardware Engineering Ultrasound (Bothell, WA)The Global Hardware Engineering Leader defines and drives the technical direction for our Hardware Engineering group within the Ultrasound business and manages the overall capabilities of the department to ensure that business objectives can...