Director, GTS Quality Systems

BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.

General Description:

The Director, Quality Systems will report to the Sr. Director, Quality Systems and Validation and serve as a Global Technology Solutions leader responsible for the technology operations, deployment, and lifecycle support of enterprise Quality Management System (QMS) platforms, Veeva Quality applications, other Quality Assurance systems, and related GxP applications.

This role will be primarily GTS-facing, with accountability for translating Quality business needs and QMS process requirements into technology execution plans, managing application operations, coordinating project delivery, overseeing vendors and managed service partners, and ensuring reliable, compliant, and scalable Quality technology solutions. The individual will work closely with Global Quality, site Quality, business process owners, and GTS functions to support the Quality Systems roadmap, manage budgets and forecasts, prioritize demand, and deliver system enhancements and projects.

The individual must have hands-on configuration and system administration experience with Veeva Quality applications and a strong working understanding of Quality Assurance processes supported by systems such as document management, training, deviations, CAPA, change control, complaints, audits, risk management, and inspection readiness. The role must bring a strong understanding of the Quality and regulated GxP environment, including data integrity, change control, validation, and CSA expectations.

Essential Functions of the job:

Lead GTS delivery, deployment, and operational support for enterprise QMS platforms and other Quality Assurance systems, with emphasis on Veeva Quality applications and related integrations.

Manage application operations across QMS and QA technology platforms, including incident and problem management, enhancement intake, configuration oversight, release coordination, service performance, operational metrics, user support, and lifecycle planning.

Experience leading enterprise QMS deployments, enhancements, application support, and project delivery for Quality Assurance systems in a pharmaceutical, biotechnology, or life sciences environment is required. Hands-on experience with Veeva Quality applications is required, including practical involvement in implementation, configuration review, release support, testing coordination, issue resolution, and operational support.

Translate Quality Assurance business requirements, QMS process needs, and compliance expectations into practical technology plans, Veeva configuration and enhancement approaches, delivery commitments, system changes, and support models in partnership with Quality stakeholders and GTS functions.

Strong GTS or IT delivery experience is required, including service management, vendor management, release coordination, budget management, demand management, roadmap support, and cross-functional technology delivery. Working knowledge of 21 CFR Part 11, data integrity expectations, GxP computer system validation, and Computer Software Assurance principles is required, with emphasis on applying approved procedures and maintaining validated systems rather than designing enterprise validation strategy.

Experience with Quality platforms such as Validation Management System (Val Genesis), Inspection Management, AI tools used in pharma, laboratory, manufacturing, training and/or other regulated Quality systems is preferred.

Manage delivery of Quality technology projects and initiatives, including scope, schedule, resources, budget, risks, dependencies, vendor performance, stakeholder communication, and operational readiness.

Provide hands-on leadership for Veeva Quality deployment activities, including requirements clarification, solution design input, configuration review, data and integration considerations, testing coordination, defect resolution, release readiness, and post-go-live stabilization.

Support deployment and enhancement of QA systems supporting document control, training, deviations, CAPA, change control, complaints, audits, quality risk management, supplier quality, inspection readiness, and related Quality processes.

Demonstrated ability to work across GTS, Quality,…