Director, QMS BPO, Quality Issue Escalation, Risk & Knowledge Management

BeOne Medicines

Director, QMS BPO responsible for managing escalated GxP and Quality incidents at BeOne. Leading incident prevention measures and compliance with regulatory requirements.

Posted 6/2/2026full-timeRemote • California • 🇺🇸 United StatesLead💰 $172,000 - $232,000 per yearWebsite

About the role

Key responsibilities & impact

Managing assigned escalated GxP and Quality incidents in an end-to-end process on global level
Initiating GxP/Quality incident prevention measures
Maintaining (incl continuous improvement) of defined incident management related processes within regulated environments on global level
Leading and overseeing that quality incidents are managed effectively
Ensuring compliance with regulatory requirements (e.g., ICH Q9)
Building and growing the knowledge management processes and tools to enable rapid access to data and knowledge over the entire product lifecycle

Requirements

What you’ll need

Bachelor’s degree and 8+ years of experience in quality sciences, quality systems, or related fields within a regulated industry (e.g., pharmaceuticals, biotechnology, medical devices)
Master’s degree and 10+ years direct experience preferred
6 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources
Strong PC literacy required; MS Office skills (Outlook, Word, Excel, PowerPoint)
Experience with regulatory interactions including notification and communication with health authorities on global level for sensitive compliance topics

Benefits

Comp & perks

Medical
Dental
Vision
401(k)
FSA/HSA
Life Insurance
Paid Time Off
Wellness

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

GxPQuality incident managementIncident prevention measuresRegulatory complianceICH Q9Knowledge management processesContinuous improvementQuality systemsQuality sciencesManagerial experience

Soft Skills

LeadershipTeam managementProject managementResource allocationCommunicationInterpersonal skillsOrganizational skillsProblem-solvingDecision-makingCollaboration