Director, Product Quality Lead
About The Position
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.
Requirements
- 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).
- 5 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources.
- Strong PC literacy required; MS Office skills (Outlook, Word, Excel, PowerPoint).
Nice To Haves
- Master’s degree and 10+ years experience preferred
- Experience in statistical modeling software (Mintab, JMP, Tableau, SciLab
- 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 functions
Responsibilities
- 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.
Benefits
- Medical
- Dental
- Vision
- 401(k)
- FSA/HSA
- Life Insurance
- Paid Time Off
- Wellness
- discretionary equity awards
- Employee Stock Purchase Plan
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What This Job Offers
Job Type
Full-time
Career Level
Manager
