Find & Apply For Quality Control Systems Manager Jobs in San Mateo, California

• 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 functions

Travel:

Up to 20%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.