Responsible for administering, maintaining, and continuously improving Apnimed's electronic Quality Management System (eQMS) and associated quality processes, ensuring inspection readiness and supporting regulatory compliance.
Compensation
The expected annual base salary range for this role is $170,000.00 to $190,000.00.
Responsibilities
Serve as subject matter expert and administrator for the electronic Quality Management System (eQMS), evaluating proposed system changes and coordinating testing, validation, and deployment activities.
Support the integration of new business processes, departments, and vendors into the Quality Management System, and oversee onboarding, knowledge transfer, and competency requirements for new eQMS administrators.
Maintain system documentation, including procedures, work instructions, validation documentation, and configuration records.
Administer the training program: confirm assignments and curricula reflect quality system responsibilities, manage role-based eQMS training and user support, and maintain a centralized library of user guidance, job aids, and FAQs.
Provide oversight and support for core quality processes, including document control, deviations, CAPAs, change controls, investigations, supplier quality records, and training management.
Requirements
Bachelor's degree or equivalent in a scientific, technical, engineering, quality, or related discipline.
Nice to have: Direct administrator experience with Veeva Quality
Nice to have: Experience with computerized system validation (CSV) and 21 CFR Part 11 compliance
Nice to have: Experience supporting both development-stage and commercial pharmaceutical operations
Nice to have: Implementing or enhancing eQMS platforms
Lead Engineer, IT Compliance, Data Integrity is an individual contributor within the Cell Therapy Information Technology organization supporting Bristol Myers Squibb's Bothell, WA manufacturing site.
Compensation
Bothell - WA - US: $118,280 - $143,325
Responsibilities
Lead IT compliance and data integrity programs supporting GxP computerized systems used in Cell Therapy manufacturing, quality, laboratory, and business operations.
Facilitate and oversee Data Integrity Risk Assessments (DIRAs), Quality Risk Assessments (QRAs), system impact assessments, and compliance evaluations.
Lead complex investigations, root cause analyses, deviation management activities, CAPA development, and effectiveness monitoring using structured problem-solving methodologies.
Support computerized system validation activities throughout the system lifecycle, including risk assessments, validation strategies, protocol reviews, implementation support, and periodic reviews.
Conduct compliance assessments and change impact evaluations for system upgrades, enhancements, infrastructure changes, and digital transformation initiatives.
Requirements
Bachelor's degree in Information Technology, Chemical, Engineering, Computer Science, Life Sciences, Biotechnology, Pharmaceutical Sciences, Education, Organizational Development, Business Administration, or a related field.
Nice to have: Master's degree or Doctoral degree in Education, Organizational Leadership, Learning & Development, Business Administration, Engineering, Information Technology, Pharmaceutical Sciences
Supervisor of Quality Control (QC) Lab Operations to support a highly automated drug substance manufacturing facility.
Compensation
$80,300.00 - $131,300.00
Responsibilities
Hire, onboard, and develop team; define individual development plans tied to technical and leadership competencies
Set goals, provide ongoing coaching and feedback, and conduct performance reviews; address performance gaps through documented coaching and improvement plans
Maintain training compliance for direct reports and a team skills matrix covering equipment qualification, CSV, LIMS and CDS integration, and GMP document authorship
Maintain the integrated portfolio of lab builds, technology implementations, and upgrades scope, schedule, resource loading, and cross-project dependencies
Review scoping and business cases developed by the team; recommend prioritization and funding requests to QC management
Requirements
BS/BA in Life Sciences, Chemistry, or Engineering discipline
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