General Description:

The Senior Manager of R&D Quality Operations & Excellence (RDQ Operations) 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. This role focuses on Clinical Quality Management processes and the associated strategy, metrics, and optimization. The Senior Manager can be assigned to manage Significant Quality Events (SQEs), Corrective and Preventive Actions (CAPAs), and Serious Breaches (SBs). Additionally, the role supports Risk-Based Quality Management (RBQM), Quality by Design, data analytics, and process improvement across the R&D Quality function. The position also leads proactive initiatives in quality assurance and continuous improvement, maintaining a fit-for-purpose QMS. This role is crucial in ensuring the integrity and excellence of BeiGene’s R&D processes.

Essential Functions of the Job:

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

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

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

• 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.

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

• Maintains quantifiable metrics for R&D Quality systems and processes such as SQEs/deviations, CAPAs, internal audits, external audits, inspections and findings.

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

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

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

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

• Collaborate with cross-functional departments (e.g., Clinical Operations, Regulatory, Pharmacovigilance, and Laboratory teams) to align quality strategies and enhance compliance across the organization.

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

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

• 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.

• Support the inspection readiness activities and participate in managing regulatory health authority inspections as needed

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

• 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 4+ years, or PhD/MD/PharmD with 2+ 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.