Overview
BeOne Medicines is seeking an Associate Director, External Supply Quality Europe. The role has global responsibility for commercial product quality at Contract Manufacturing Organizations (CMOs) and lifecycle management projects, ensuring products are manufactured, packed, labeled, stored and transported in compliance with regulatory expectations and GMP/GDP standards. The position supports compliance with international regulations and BeOne quality standards across CMOs. Location: remote in Europe; hybrid pattern with 3 days per week in Basel office and 2 days remote.
Responsibilities
* Lead Small Molecule and Large Molecule commercial product quality efforts to ensure quality management processes meet regulatory requirements and BeOne standards.
* Accountable for BeOne qualified CMO oversight in Europe, including performance management, trend evaluation and remediation as required.
* Serve as primary escalation point for CMO quality managers.
* Review and approve change control strategies for CMO-notified changes.
* Oversee and manage APQR activities for CMO-manufactured BeOne products.
* Lead batch-related deviation handling, investigations and CAPA execution at CMOs.
* Conduct PIP (Person in Plant) activities as needed.
* Oversee inspection management to support successful CMOs or BeOne-hosted inspections (e.g., PAIs, PV inspections).
* Ensure quality processes meet Health Authority expectations and continuously improve by capturing regulation changes.
* Advise and support Quality Agreement content, implementation and updates.
* Collaborate cross-functionally with Manufacturing, Supply Chain, Regulatory CMC and other Quality teams (e.g., EU QPs).
* Provide quality support for commercial product supply including timely batch release; assist with product recalls when needed.
* Perform other tasks per SOPs, regulatory requirements and GxP guidelines.
* Work with Clinical Product Quality, Regulatory and CMC to establish Process Performance Qualification for Small Molecule products.
* Author and maintain Standard Operating Procedures related to the function and department.
Supervisory Responsibilities
* Manage, develop and coordinate a medium-sized team based in Europe.
* Accountable for financial control and related budgets (headcount, travel, etc.).
* Ensure resources are trained with GMP/GDP knowledge and foster ongoing professional development.
* Build a talent pipeline and create a supportive environment for career growth.
* 6+ years of managerial experience with direct people management.
Qualifications
* In-depth GMP experience in quality and manufacturing for small molecules and large molecules.
* Ability to apply logical and scientific thinking to a wide range of problems.
* Strong computer skills (MS Office: Outlook, Word, Excel, PowerPoint).
Travel
May travel regionally and intercontinentally up to 30%.
Global Competencies
* Fosters Teamwork
* Provides and Solicits Honest and Actionable Feedback
* Self-Awareness
* Acts Inclusively
* Demonstrates Initiative
* Entrepreneurial Mindset
* Continuous Learning
* Embraces Change
* Results-Oriented
* Analytical Thinking/Data Analysis
* Financial Excellence
* Communicates with Clarity
BeOne Medicines is an equal opportunity employer. BeOne 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 applicable law. All employment is decided on the basis of qualifications, merit, and business need.
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