Beschreibung

In this role, you will lead a team focused on ensuring the quality of externally manufactured products, overseeing compliance with regulations, and managing inspections. Your day-to-day responsibilities will involve collaborating with various departments to support product quality and timely batch releases.

Anforderungen

• •6+ years of managerial experience
• •Ability to lead teams and manage staff
• •Strong PC literacy; MS Office skills
• •In-depth GMP experience in quality and manufacturing
• •Ability to apply logical and scientific thinking
• •Inspiring and encouraging team members

Aufgaben

• •Lead the Small Molecule commercial product quality team
• •Ensure compliance with regulatory requirements and BeOne standards
• •Oversee BeOne qualified CMO performance management in Europe
• •Evaluate trends and implement remediation as needed
• •Act as the primary escalation point for CMO quality managers
• •Review and approve change control strategies for CMO changes
• •Manage APQR activities for CMO manufactured BeOne products
• •Handle batch-related deviations and implement effective CAPAs at CMO
• •Perform PIP (Person in Plant) activities
• •Oversee inspection management for successful CMO and BeOne inspections
• •Ensure quality processes meet Health Authorities' expectations
• •Advise on Quality Agreement content and updates
• •Collaborate cross-functionally with Manufacturing, Supply Chain, and Regulatory CMC
• •Ensure timely batch release for commercial product supply
• •Support product recalls from the commercial supply chain when necessary
• •Author Standard Operating Procedures for the department

Tools & Technologien