Director, Product Quality Lead

BeiGene, Ltd.; Northern (KY); Hybrid; USD 172,000 - 232,000; Full time

Benefits offered by this job

Medical benefits

Dental benefits

Vision benefits

401(k) retirement plan

FSA/HSA

Life Insurance

Paid time off

Wellness program

Job summary

BeOne Medicines Ltd. seeks a Director, Product Quality Lead to advance global quality initiatives, drive risk management, and strengthen knowledge sharing across sites.

You will mentor teams, coordinate cross‑functional efforts with R&D, CMC, and regulatory, and shape strategies for lifecycle management. The role requires strong leadership, regulatory acumen, and the ability to manage complex investigations while guiding continuous improvement and training programs.

Qualifications

• Bachelor’s degree and 8+ years of experience in quality sciences, quality systems, or related fields within a regulated industry (e.g., pharmaceuticals).
• Master’s degree and 10+ years experience preferred.
• Extensive experience in leading quality investigations, quality risk management, and implementing new technologies.

Responsibilities

• Represent the Quality Organization at platform level through governance meetings and forums.
• Serve as SME for quality risk assessment, investigations, change control, and complex issue resolution.
• Manage Product Quality Network teams delivering for late‑phase programs or commercial products.
• Collaborate with R&D, CMC, and regulatory teams to embed quality in development and lifecycle management.
• Advise on CMC strategies and quality risk management for commercialization, including in‑process controls and stability.
• Contribute to product quality performance monitoring, identify trends, and drive improvements.
• Lead cross‑functional teams to improve quality systems and address systemic challenges.
• Support Quality Risk Management frameworks and regulatory inspections; mentor team members.
• Understand emerging scientific trends and their impact on BeOne Medicines Ltd. products.
• Travel up to 20% to support global operations.

Skills

Quality management

Regulatory knowledge

Leadership

Root cause analysis

Lean Six Sigma

Change control

Risk assessment

Communication

Training delivery

Statistical tools

Education

Bachelor's degree

Master's degree

Tools

Mintab

JMP

Tableau

SciLab

Job description

## Director, Product Quality LeadApplylocations: Remote (US)time type: Full timeposted on: Posted Todayjob requisition id: R34502BeOne 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 Product Quality Lead, as part of the Quality Sciences and Knowledge Management organization, will play a critical role in advancing global quality initiatives, ensuring the highest standards of product quality, and fostering expertise in emerging quality technologies. This position will contribute to quality risk management, knowledge-sharing strategies, and the development of technical training programs to strengthen compliance, operational excellence, and innovation. The PQL will support cross-functional collaboration, drive process improvements and enhance the organization's approach to quality governance.This individual will collaborate across functions and sites to drive continuous improvement, ensure regulatory compliance, and build a robust knowledge-sharing and risk management culture.* Represent the Quality Organization at platform level through participation in molecule level governance meetings and forums.* Serve as a Subject Matter Expert (SME) and Facilitator for quality risk assessment, investigations, change control, and resolution of complex quality issues including review of regulatory CMC submission content* Manage Product Quality Network teams responsible for deliverables for multiple late-phase clinical or commercial programs* Collaborate with R&D, manufacturing (CMC) and regulatory teams to ensure quality considerations are embedded in new product development and lifecycle management.* Advise on CMC strategies and quality risk management for commercialization including strategies for in process controls, specifications, stability, and comparability* Contribute to product quality performance monitoring, identifying trends and driving improvements.* Lead or participate in cross-functional teams to improve quality systems and address systemic challenges.* Support the development and implementation of Quality Risk Management (QRM) frameworks, ensuring compliance with regulatory requirements (e.g., ICH Q9).* Support regulatory inspections and audits, ensuring alignment with global quality standards and best practices.* Actively mentoring new and existing team members to develop core Product Quality skills and leadership skills* Understanding and responding to the impact of emerging scientific/technical trends and their implications for BeOne / BeiGene Products.* Perform other related responsibilities as assigned.**Education/Experience Required:*** Bachelor’s degree and 8+ years of experience in quality sciences, quality systems, or related fields within a regulated industry (e.g., pharmaceuticals, biotechnology, medical devices).* Master’s degree and 10+ years experience preferred**Supervisory Responsibilities:*** 5 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources.**Computer Skills:*** Strong PC literacy required; MS Office skills (Outlook, Word, Excel, PowerPoint).* Experience in statistical modeling software (Mintab, JMP, Tableau, SciLab**Other Qualifications**:* Advanced degree in life sciences, quality management, or related field* Extensive experience in leading quality investigations, quality risk management, and implementing new technologies.* Expertise in quality systems, regulatory requirements (e.g., FDA, EMA), and risk management frameworks (e.g., ICH Q9).* Strong leadership and problem-solving skills, with the ability to manage complexity and ambiguity.* Experience in developing and delivering global training programs ad fostering SME networks.* Proficiency in quality tools and methodologies (e.g., root cause analysis, Lean, Six Sigma).* Ability to communicate complex information clearly and effectively across business functionsTravel: Up to 20%Global CompetenciesWhen 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 ClaritySalary Range: $172,000.00 - $232,000.00 annuallyBeOne 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 BeOne Medicines 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. 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. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans’ Readjustment Assistance Act of 1974, Title I of the Americans with Disabilities Act of 1990, and any other applicable federal, state or local laws, applicants who require reasonable accommodation in the job application process may contact [e-mail].