BeOne Medicines I GmbH is hiring an Associate Director, BPO Global APQR & Product Data Quality

BeOne Medicines I GmbH is hiring an Associate Director, BPO Global APQR & Product Data Quality. You will own the process that captures and examines product knowledge throughout the commercial lifecycle, using data trending and statistical analysis to ensure robust and continuously improving systems. As the Product Data Quality Steward, you will ensure reliable access to product information and process knowledge across functions via QMS systems, collaborating widely to build a strong culture of knowledge-sharing and risk management.

What You'll Do

• 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 mentor 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 products.

What We're Looking For

• 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).

Nice to Have

• Master’s degree and 8+ years of experience.
• 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).
• Ability to communicate complex information clearly and effectively across business functions.

Technical Stack

• MS Office (Outlook, Word, Excel, PowerPoint)
• Specialized platforms (Veeva, Power BI, Calyx, SAP, etc)
• Statistical modeling software (Minitab, JMP, Tableau, SciLab, etc.)

Benefits & Compensation

• Compensation: $143,400.00 - $193,400.00 annually + equity: Eligible for discretionary equity awards
• Medical, Dental, Vision insurance
• 401(k)
• FSA/HSA
• Life Insurance
• Paid Time Off
• Wellness programs
• Eligibility to participate in the Employee Stock Purchase Plan
• Non-Commercial roles eligible for annual bonus plan
• Commercial roles eligible for incentive compensation plan

We are proud to be an equal opportunity employer. BeiGene does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law.