Senior Manager, R&D Quality Operations & Excellence

BeiGene, Ltd. has proposed to change its name to BeOne Medicines Ltd. The new name is subject to shareholder approval and, once approved, use of the name will be phased in over 2025. There may be instances where “BeiGene” or “BeOne” are used to describe the company during this transition period. BeOne 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 (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.

Global Competencies

When we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity and Collaborative Spirit, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.

• Fosters Teamwork
• Provides and Solicits Honest and Actionable Feedback
• Self-Awareness
• Acts Inclusively
• Demonstrates Initiative
• Entrepreneurial Mindset
• Continuous Learning
• Embraces Change
• Results-Oriented
• Analytical Thinking/Data Analysis
• Financial Excellence
• Communicates with Clarity

Salary Range: $130,600.00 - $175,600.00 annually

BeOne is committed to fair and equitable compensation practices. Actual compensation packages are determined by several factors that are unique to each candidate, including but not limited to job-related skills, depth of experience, certifications, relevant education or training, and specific work location. Packages may vary by location due to differences in the cost of labor. The recruiter can share more about the specific salary range for a preferred location during the hiring process.  Please note that the listed range reflects the base salary or hourly range only. Non-Commercial roles are eligible to participate in the annual bonus plan, and Commercial roles are eligible to participate in an incentive compensation plan. All Company employees have the opportunity to own shares of BeiGene, Ltd. stock because all employees are eligible for discretionary equity awards and to voluntarily participate in the Employee Stock Purchase Plan. The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness.

We are proud to be an equal opportunity employer and we value diversity. BeOne does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.