Associate Director, BPO Global APQR & Product Data Quality
BeOne Medicines, Emeryville, California, United States, 94608
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.
Education and Experience Required:
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
Supervisory Responsibilities:
3 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).
Ability to learn specialized platforms (Veeva, Power BI, Calyx, SAP, etc) and statistical modeling software (Mintab, JMP, Tableau, SciLab, etc.)
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.
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.
Education and Experience Required:
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
Supervisory Responsibilities:
3 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).
Ability to learn specialized platforms (Veeva, Power BI, Calyx, SAP, etc) and statistical modeling software (Mintab, JMP, Tableau, SciLab, etc.)
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.