General Description: This position has overall responsibility for Global Patient Safety (GPS) audit and inspection readiness activities, including leading inspection preparation and coordination efforts. Additionally, the position is responsible for managing a defined portfolio of Quality Events originating from inspections, audits, and compliance monitoring sources. The individual operates under the direction of the Senior Director, GPS Operations and Quality Management (QMO). The position contributes to the delivery of objectives and goals set for the GPS Quality Management Operations functional area.
Essential Functions of the job:
GVP Audit & Inspection Readiness Activities
In alignment with the Senior Director, GPS Quality Management Operations:
Leads BeiGene PV inspection strategy and preparation activities
Oversees forecasting and proactive inspection readiness planning
Coordinates GPS inspection readiness activities across the function
Leads and supports GPS activities across all phases of GxP inspections and audits (preparation, conduct, response, SQE, and CAPA development and execution).
Prepares and supports GPS subject matter experts for PV audits and inspections.
Manages written and verbal inspection and audit-related requests.
Conducts analyses to support regional PV audits and inspections of the GPS PV system and collaborates with stakeholders to proactively identify and resolve deficiencies.
Develops and maintains GVP inspection intelligence tools, including inspection guides, surveys, training materials, and checklists, to ensure sustained inspection readiness.
Conducts trending analyses across GVP inspections, as assigned, and provides actionable insights to enhance the effectiveness of the PV QMS.
Ensures PV support is provided to QA teams to facilitate the preparation and management of regional regulatory inspections.
Delivers inspection readiness training.
Communicates inspection status and outcomes to GPS stakeholders.
Provides insights into areas of risk and supports mitigation strategies in collaboration with subject matter experts during audits and inspections.
Supports PV activities related to audits and inspections of business partners and vendors conducting pharmacovigilance activities on behalf of GPS.
Represents GPS as a subject matter expert during audits and inspections.
GPS Quality Management Operations
As assigned, responsible for the conduct of investigations into quality issues identified within GPS, including ensuring event analyses, root cause investigations, corrective actions and preventive actions (CAPA) are thoroughly documented in the Quality Management System (QMS).
Responsible for the follow-up of CAPA plans from self-identified, auditing, and inspection activities, as needed.
In collaboration with GPS Quality Management Operations team members, responsible for ensuring the GPS QMS is functioning effectively and in compliance with global regulatory authority requirements.
Leads compliance related meetings and manages key GPS quality operations processes, as assigned.
Leads or supports the development and implementation of GPS Key Performance Indicators (KPI) used to determine the effectiveness of the overall pharmacovigilance (PV) system, as assigned.
Leads or supports other GPS Quality Management Operations team members in the execution of continuous improvement initiatives across GPS, as assigned.
Responsible for the implementation and maintenance of GPS issue management procedures in collaboration with BeiGene's Quality Assurance function.
Leads, supports, and/or participates in quality and compliance projects and programs, as assigned.
Functional Area Support
Supports PV legislation monitoring and evaluation, including impact analysis and implementation of regulatory changes, ensuring alignment with overall GPS inspection readiness.
Contributes to the maintenance and continuous improvement of the GPS Quality Management System (QMS), including support for QMS-related programs, projects, and benchmarking activities.
Supports global business continuity planning to minimize disruption to PV activities.
Supports the functioning of QPPV offices and facilitates communication of regional QMS activities to functional areas and senior management.
Contributes to organizational and strategic initiatives across GPS, including talent development, organizational effectiveness, and broader business priorities.
Education / Experience:
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, including management of the resolution of audit and inspection outcomes.
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.
Other Qualifications:
Demonstrated ability to develop and maintain standard operating procedures for pharmacovigilance (PV) processes.
Proven ability to build, develop, and influence relationships and partnerships (internal and external) across all levels of the organization, with strong leadership and influencing skills.
Excellent oral and written communication skills, including experience in public speaking and group facilitation.
Strong interpersonal skills with a high level of personal integrity.
Ability to navigate ambiguity and make sound decisions in a high-growth, rapidly evolving environment.
Ability to anticipate strategic business needs to ensure patient safety operations remain compliant.
Ability to manage multiple priorities and deliver results within established timelines, demonstrating a sense of urgency when needed.
Highly proactive in engagement, collaboration, and negotiation with colleagues, including those outside of GPS.
Travel: International and domestic, 5 - 10%
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
