Director, GTS Quality Systems

BeiGene•Hopewell, NJ

3d•$172,500 - $232,500•Remote

About The Position

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.

Requirements

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.
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 QA business processes such as document control, training, deviations, CAPA, change control, complaints, audits, quality risk management, supplier quality, and inspection readiness is required.

Nice To Haves

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

Responsibilities

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.
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.
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, site stakeholders, Procurement, Finance, and vendors to deliver reliable, compliant, and business-aligned technology solutions.
Support creation, maintenance, and execution of the Quality Systems roadmap by partnering with Quality and GTS leadership to consolidate demand, assess technical feasibility, estimate effort and cost, sequence priorities, and convert roadmap items into executable delivery plans.
Manage department and project budgets, including supporting forecasting, annual planning input, purchase requisitions, purchase orders, vendor spend oversight, accrual support, and routine financial reporting to leadership.
Partner with GTS architecture, infrastructure, cybersecurity, data, integration, service management, procurement, finance, and external vendors to deliver and support Quality technology solutions.
Ensure Quality systems remain in a validated and compliant state by following approved SOPs, change control, release management, validation, CSA, data integrity, access management, and system lifecycle procedures.
Coordinate and support validation and CSA deliverables for system changes and projects, including planning input, documentation coordination, testing evidence review, deviation support, release readiness, and operational handover.
Maintain strong working knowledge of Quality business processes, GxP expectations, inspection readiness, and regulated system operations to ensure technology decisions appropriately support the Quality organization.
Monitor technology service trends, compliance risks, project status, resource constraints, and vendor performance; escalate issues and recommend practical improvements to strengthen operational reliability and business value.
Provide clear communication to Quality and GTS leadership regarding project delivery, operational performance, roadmap progress, budget status, risks, tradeoffs, and decisions required.
Will have direct supervisory responsibility for approximately three direct reports supporting Quality technology operations, application support, and project delivery.
Provide coaching, performance management, workload prioritization, and professional development for team members in a GTS operating model.
Establish clear team priorities, operating rhythms, service expectations, project assignments, and accountability for technology operations, system lifecycle activities, and delivery commitments.
Promote collaboration across GTS functions, Quality business stakeholders, site teams, vendors, managed service partners, and shared service functions to resolve issues and deliver business outcomes.
Maintain strong communication, technical writing, stakeholder management, financial management, and presentation skills appropriate for cross-functional technology and Quality leadership forums.