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.
Ensures process(es) are robust, in continued state of validation and continuously improving.
Provides second line technical/scientific process support.
Supports cross-functional collaboration, drives process improvements and enhances the organization's approach to quality governance.
Collaborates across functions and sites to drive continuous improvement and ensure regulatory compliance.
Manages change tracking and implementation for actions related to Regulatory CMC commitments.
Leads or participates in cross-functional teams to improve quality systems and address systemic challenges.
Represents the Quality Organization at platform level through participation in molecule level governance meetings and forums.
Supports regulatory inspections and audits, ensuring alignment with global quality standards and best practices.
Actively mentors new and existing team members to develop core Product Quality skills and leadership skills.

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).
Master’s degree and 8 + years' experience preferred
3 years of managerial experience directly managing people and/or leadership experience
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.)
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 and fostering SME networks.
Proficiency in quality tools and methodologies (e.g., root cause analysis, Lean, Six Sigma).

Associate Director, BPO Global APQR, Product Data Quality

Key skills