General Description:

The Senior Manager of R&D Quality Systems, Strategy, and Excellence (Process & Procedure) 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 is responsible for driving the strategic implementation of Quality by Design (QbD), ensuring excellence in documentation practices, and embedding quality into all processes, protocols, and procedures. This role focuses on proactive process management and quality events by tracking issues and trends, owning the process impact assessment, and ensuring that processes are aligned with regulatory requirements, industry best practices, and internal standards. The position plays a key role in fostering continuous improvement, supporting process optimization, and reducing quality risks.

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:

• Support integration of QbD principles throughout R&D processes to ensure proactive quality assurance while collaborating with cross-functional teams to design and refine processes that align with internal standards, minimize risks, and reflect the latest industry and regulatory requirements.

• Support the process impact assessment process, reviewing new and revised SOPs prior to authoring to assess their impact, risk, alignment with industry trends, and GxP requirements.

• Support internal SOP Committee focused on providing support to cross functional teams to review new controlled procedures or procedures requiring substantial cross functional feedback

• Develop and maintain systems for tracking issues, deviations, CAPAs, and quality events across processes, protocols, and procedures and analyze trends to identify potential systemic issues.

• Work with stakeholders to embed preventive quality controls in processes and procedures, helping to identify potential risks before they result in deviations or non-compliance.

• Lead root cause analysis for quality events and implement preventive measures to improve process robustness and reduce future risks.

• Manage and lead the quality review process for SOPs and other controlled documents before release, ensuring alignment with regulatory and internal standards.

• Collaborate with document owners to ensure that procedures are both practical and compliant, facilitating easier implementation across teams.

• Build strong partnerships across departments (e.g., Clinical Operations, Regulatory Affairs, R&D) to ensure that quality is embedded throughout the product development lifecycle.

• Promote a quality-focused culture by providing guidance, best practices, and training to functional teams, supporting their efforts to maintain high-quality standards.

• Lead continuous improvement initiatives by identifying opportunities for process optimization, balancing quality control with operational efficiency.

• Stay updated on industry trends, regulatory changes, and emerging best practices to ensure that the organization remains at the forefront of quality process management.

• 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 GxPs, FDA, EMA and ICH requirements.

• Bachelor's degree with 6+ years, Master’s degree with 4+ years, or PhD/MD/PharmD with 2+ years of R&D quality assurance experience.

• Expertise in Quality by Design (QbD) and Good Documentation Practices (GDP).

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

• Demonstrated experience in quality management, process management/improvement, and risk assessment.

• 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.

• 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.

Computer Skills :

• PC literacy required; MSOffice skills (Outlook, Word, Excel, PowerPoint, Project)

• History of working with Veeva QMS System is preferred

Other Qualifications:

Communication & Interpersonal Skills

• Excellent verbal and written communication skills

• Ability to effectively collaborate in a dynamic environment

Significant Contacts

• Quality

• Clinical Operations

• Pharmacovigilance

• Clinical Business Operations

• Risk Based Quality Management

• Biometrics

• Medical Monitors

• Regulatory Affairs

• Global Technology Solutions

• Interacts with all levels of BeiGene

Travel:

May require up to 20% travel

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.