Associate Director, BPO Global APQR & Product Data Quality

BeiGene

19h

About The Position

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 AD BPO Global APQR owns the process which captures and examines BeOne’s product knowledge throughout the commercial lifecycle, maintains oversight on process capability through data trending and statistical analysis of critical variables, ensuring process(es) are robust, in continued state of validation and continuously improving. As a Product Data Quality Steward, ensures, the reliability and access to product information, process knowledge across functions via QMS systems. Provides second line technical/scientific process support. The Data Quality Steward will support cross-functional collaboration, drive process improvements and enhance the organization's approach to quality governance using evidence backed decision making. 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. As Business Process Owner for the Global APQR process, contribute to product quality performance monitoring, identifying trends and driving improvements. Collaborate with R&D, manufacturing (CMC) and regulatory teams to ensure quality considerations are embedded in new product development and lifecycle management. Manage change tracking and implementation for actions related to Regulatory CMC commitments Lead or participate in cross-functional teams to improve quality systems and address systemic challenges. Represent the Quality Organization at platform level through participation in molecule level governance meetings and forums. 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 6+ years of experience in quality sciences, quality systems, or related fields within a regulated industry (e.g., pharmaceuticals, biotechnology, medical devices).
• 3 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).
• Ability to learn specialized platforms (Veeva, Power BI, Calyx, SAP, etc) and statistical modeling software (Mintab, JMP, Tableau, SciLab, etc.)

Nice To Haves

• Master’s degree and 8 + years' experience preferred
• 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

• The AD BPO Global APQR owns the process which captures and examines BeOne’s product knowledge throughout the commercial lifecycle
• Maintains oversight on process capability through data trending and statistical analysis of critical variables, ensuring process(es) are robust, in continued state of validation and continuously improving.
• As a Product Data Quality Steward, ensures, the reliability and access to product information, process knowledge across functions via QMS systems.
• Provides second line technical/scientific process support.
• Support cross-functional collaboration, drive process improvements and enhance the organization's approach to quality governance using evidence backed decision making.
• Collaborate across functions and sites to drive continuous improvement, ensure regulatory compliance, and build a robust knowledge-sharing and risk management culture.
• Contribute to product quality performance monitoring, identifying trends and driving improvements.
• Collaborate with R&D, manufacturing (CMC) and regulatory teams to ensure quality considerations are embedded in new product development and lifecycle management.
• Manage change tracking and implementation for actions related to Regulatory CMC commitments
• Lead or participate in cross-functional teams to improve quality systems and address systemic challenges.
• Represent the Quality Organization at platform level through participation in molecule level governance meetings and forums.
• 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

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level