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General Description:

The Senior Manager of R&D Quality Systems, Strategy, and Excellence (QMS) is responsible for implementing and maintaining a balanced, proactive, risk-based, and phase-appropriate approach to Quality Assurance across the Research and Development pipeline. The position ensures that research and development activities comply with applicable regulatory requirements, guidelines, and internal standards. Within the R&D Quality Systems, Strategy, and Excellence, focus will be allocated across key areas of the quality management system including but not limited to, QMS strategy and metrics, quality process management, QMS 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, process improvement, 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 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.

Essential Functions of the Job:

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

• Oversee QMS activities related to FDA and ROW regulations across therapeutic areas and provide GxP guidance for all phases of drug development.

• Help drive implementation of Risk Based Quality Management and Quality by Design principles.

• Oversee metrics for QA systems such as SQEs/deviations, CAPAs, internal audits, external audits, and findings.

• Collaborate with cross functional compliance teams to develop integrated Quality Management Risk plans.

• Lead the analysis and interpretation of key quality data for presentation and reporting to functional and executive leadership through strategic and impactful metrics review.

• Act as primary R&D Quality point of contact to work closely with central QMS team to continually optimize QMS functionality for R&D GxP workflows for Deviation, CAPA, Effectiveness Checks, Audits, and Findings.

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

• Define, analyze, and report metrics and measures for R&D Quality to drive assessments and continuous improvement.

• 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.

• Oversee the development, maintenance, and execution of the R&D Quality Management System (QMS) to ensure compliance with GCP, GLP, and GVP regulations.

• Proactively identifying regulatory risks and process gaps through monitoring of available data and Key performance/Quality Indicators (KP(Q)Is) and development of risk-mitigation strategies/plans to mitigate risk.

• Participating in the review of study related metrics (i.e; protocol deviation, etc.) as part of the Quality Management Risk (QMR) approach to identify gaps, trends, and the need for process improvements.

• Collaborate with R&D Quality Audit Management, Inspection Management, GVP, GLP, and Quality Excellence teams aligning on identified risks and staff resourcing strategies.

• Manage/review trends and report significant investigation/deviation issues and system deficiencies to senior management, as appropriate.

• Partner with business representatives to assess processes, procedures, and protocols to identify impacts, risks, and interdependencies to build quality into BeiGene R&D Operations.

• Possess a strong global mindset and knowledge about regulations (specific expertise regulations/requirements/culture awareness) while supporting local, regional, and global teams.

• Promote continuous improvements in quality systems and department infrastructure; assist with creation/revision of appropriate Global Standards, SOPs, WIs

Additional Qualifications:

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

• Bachelor's degree with 7+ years, Master’s degree with 5+ years, or PhD/MD/PharmD with 3+ years of R&D quality assurance experience.

• Proven experience in leading teams, with a track record of developing and implementing processes and systems in a global context.

• Ability to resolve complex problems where analysis of situations or data requires an in-depth evaluation.

• Superb attention to detail, excellent review skills and the ability to organize and manage multiple tasks in a fast-paced environment.

• Exercise sound and balanced judgment in ensuring that written procedures are followed and in evaluating quality systems, processes, procedures, plans and protocols for compliance.

• Proven ability in setting strategy for and driving quality process improvement initiatives.

• Strong leadership, project management, and mentoring skills.

• Other duties as assigned

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. Therefore, it is required to have strong leadership experience and mentoring skills.

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.