Director, GPS Quality Management Operations

BeOne Medicines

Director of GPS Quality Management Operations at BeOne responsible for audit readiness, compliance, and quality event management. Leading strategies and ensuring inspection readiness for global patient safety initiatives.

Posted 4/28/2026full-timeHome Office • Texas • 🇺🇸 United StatesLead💰 $185,100 - $245,100 per yearWebsite

About the role

Key responsibilities & impact

This position has overall responsibility for Global Patient Safety (GPS) audit and inspection readiness activities
Leads BeiGene PV inspection strategy and preparation activities
Oversees forecasting and proactive inspection readiness planning
Coordinates GPS inspection readiness activities across the function
Manages written and verbal inspection and audit-related requests
Conducts analyses to support regional PV audits and inspections
Develops and maintains GVP inspection intelligence tools
Conducts trending analyses across GVP inspections
Ensures PV support is provided to QA teams
Provides insights into areas of risk and supports mitigation strategies during audits and inspections
Responsible for the conduct of investigations into quality issues identified within GPS.
Responsible for following up on CAPA plans from self-identified, auditing, and inspection activities.

Requirements

What you’ll need

Bachelor’s degree in life sciences, pharmacy, nursing or equivalent health experience
Advanced Life Sciences Degree
Minimum eight (8 to 10) years of experience in PV in operational roles
Minimum four (4) years of experience with people leadership or team leadership experience
Minimum two (2) years of experience leading regulatory inspection and audit readiness activities
Demonstrated experience in the management of PV quality management systems
Demonstrated experience implementing cross-functional partnerships and business processes
Demonstrated experience managing the development of standard operating procedures and working instructions
Strong command of global PV requirements (including EU GVP and US)
Demonstrated experience managing compliance-based training programs for PV including the ongoing evaluation of training effectiveness.

Benefits

Comp & perks

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

ATS Keywords

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Hard Skills & Tools

PV inspection strategyinspection readiness planningGVP inspection intelligence toolsPV quality management systemsstandard operating procedurescompliance-based training programsrisk mitigation strategiesanalyses for PV auditsCAPA planstrending analyses

Soft Skills

people leadershipteam leadershipcross-functional partnershipscommunicationorganizational skillsanalytical skillsproblem-solvinginsight generationcollaborationstakeholder management

Certifications

Bachelor’s degree in life sciencesAdvanced Life Sciences Degree