General Description:

The Associate Director of R&D Quality Systems, Strategy, and Excellence (Strategy & Innovation) is responsible for leading initiatives that advance a proactive, data-driven quality culture across the organization. This role focuses on leveraging quality metrics, trends, and data insights to implement risk-based strategies that improve quality outcomes and enhance decision-making processes. The Associate Director will drive cultural change and system modernization, ensuring that quality management systems (QMS) evolve across R&D to meet industry standards and future needs. A key focus will be on strategic alignment, collaborating cross-functionally and cross-GxP to ensure that R&D Quality Management Systems (QMS) are optimized for both compliance and innovation. This role is pivotal in fostering a forward-thinking quality culture and integrating data-driven insights into all aspects of quality management and operations.

The position is responsible for ensuring that BeiGene’s research, development, and pharmacovigilance activities comply with all relevant regulatory requirements, internal standards, and industry best practices. This individual will lead a proactive approach to quality assurance, quality by design, data integrity, and continuous improvement across the entire R&D Quality function while maintaining a fit-for-purpose QMS. The Associate Director will lead a team of quality professional and oversee R&D Quality Systems, Strategy, and Excellence activities.

Essential Functions of the Job:

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

• Lead the development and execution of a data-driven, risk-based quality strategy, using real-time data and analytics to identify risks, anticipate quality challenges, and proactively prevent quality events.

• Leverage quality metrics and data from across the organization to inform strategic decisions, improving both operational efficiency and regulatory compliance. Help drive implementation of Risk Based Quality Management and Quality by Design principles.

• Champion a proactive quality culture, fostering an environment where quality is integrated into every facet of the organization’s processes and systems.

• Implement change management strategies to advance quality practices, enabling the organization to shift from reactive quality control to proactive quality assurance.

• Engage leadership and teams at all levels to drive cultural change, reinforcing the importance of quality as a core business value.

• Align the organization’s quality goals with broader strategic objectives, ensuring that quality initiatives support overall business goals.

• Work with executive and senior leadership to establish quality as a key driver of innovation, operational excellence, and business success.

• Provide thought leadership and guidance on the evolving landscape of quality management, ensuring the organization stays ahead of industry trends and regulatory requirements.

• Build and maintain strong cross-functional partnerships across GxP areas (GCP, GMP, GVP) to ensure alignment in quality practices and systems.

• Collaborate closely with teams in R&D, Regulatory, Clinical Operations, and IT to ensure that data-driven quality initiatives are integrated into all aspects of the development lifecycle.

• Lead efforts to modernize the R&D Quality Management System (QMS), ensuring it is fit for purpose, scalable, and adaptable to emerging industry trends and regulatory changes.

• Implement tools and technologies to streamline quality processes, reduce complexity, and enhance transparency across the R&D QMS.

• Facilitate discussions on quality trends, risk areas, and opportunities for improvement, ensuring that leadership is equipped to make informed decisions.

• Continuously monitor industry trends and regulatory changes, ensuring that the organization’s quality strategy is forward-thinking and adaptable to the evolving landscape.

• Translate global quality themes into actionable initiatives, ensuring that R&D and broader organizational efforts remain competitive and compliant.

• Represent the organization in industry forums and collaborative efforts, ensuring that the company is at the forefront of quality innovation and modernization.

• Engage with external partners and regulatory bodies to influence industry standards and adopt best practices in proactive, data-driven quality management.

• Establish strong partnerships with key business stakeholders, including Clinical Operations, Clinical Development, Regulatory Affairs, Data Management, Biostats, GPS, RBQM, etc.

• Support the inspection readiness activities and participate in managing regulatory health authority inspections as needed Collaborate with cross-functional departments (e.g., Clinical Operations, Regulatory, Pharmacovigilance, and Laboratory teams) to align quality strategies and enhance compliance across the organization.

• Drive continuous improvement initiatives and manage quality system infrastructure to support global R&D quality processes.

Additional Qualifications:

• Expert knowledge of GCP, FDA, EMA and ICH requirements.

• Bachelor's degree with 8+ years, Master’s degree with 6+ years, or PhD/MD/PharmD with 4+ years of R&D quality assurance experience.

• Expertise in data analytics, risk management, and quality metrics tracking.

• Strong leadership skills with the ability to drive cross-functional and cross-GxP collaboration.

• Excellent communication and change management skills, with the ability to influence and inspire at all levels.

Supervisory Responsibilities:

This position may include managing staff: coaching and mentoring of junior staff with training/orientation/qualification and development plan for new Quality staff when required.

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.