Senior Manager, R&D Quality Operations & Excellence (Strategy & Structure)

BeiGene 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 Senior Manager of R&D Quality Operations & Excellence (Strategy & Structure) plays a critical role in structuring and executing quality initiatives across the R&D Quality organization. This role is focused on providing strategic oversight of portfolio and project management, supporting continuous improvement efforts, and driving process enhancements through digital innovation and change management. The Senior Manager will ensure cross-GxP strategic alignment and facilitate communication between global teams in support of the R&D Quality portfolio of work to include harmonization amongst GLP, GCP, and GVP efforts. This individual will contribute to the development and optimization of Quality Management System (QMS) processes, project management tools, and support annual goal and financial tracking, aligning R&D Quality with enterprise goals, stakeholder expectations, and regulatory requirements. Within the R&D Quality Operations & Excellence team, focus may also be allocated across key areas of quality management including but not limited to, quality insights and metrics, quality process management, process optimization, Significant Quality Event (SQE) management, Corrective and Preventive Actions (CAPAs), and Serious Breach (SB) management. These roles will also support Risk Based Quality Management (RBQM), Quality by Design (QbD), quality data analytics, and project management efforts across R&D Quality.

The position is responsible for ensuring that BeiGene’s research, development, and pharmacovigilance activities comply with all relevant regulatory requirements, internal standards, and industry’s best practices. This individual will lead a proactive and structured approach to quality assurance, quality by design, data integrity, and continuous improvement across the entire R&D Quality function by establishing an operational center of excellence within the RDQ Operations & Excellence team.

Essential Functions of the Job:

Manage and oversee R&D Quality activities which include, but are not limited to:

• Lead the portfolio management of quality projects, ensuring alignment with the organization’s strategic goals and compliance requirements.
• Oversee the planning, execution, and tracking of multiple quality improvement projects, ensuring timelines, resources, and deliverables are met.
• Implement best practices in project management, using tools and methodologies to enhance project efficiency and communication across enterprise-wide quality transformation efforts.
• Drive continuous improvement initiatives within the quality organization by identifying inefficiencies and proposing process enhancements that promote operational excellence.
• Collaborate with stakeholders to implement …