Elevate compliance standards as a Clinical Quality Manager with Hoffmann-La Roche. Oversee CDMO and CROs to ensure adherence to cGMP in clinical supply environments.
In this pivotal role, you will utilize your 8-10 years in pharmaceutical quality to conduct audits and manage quality performance across clinical product development. Engage closely with cross-functional teams, participating in site selection and qualification processes. Your expertise will be crucial in conducting risk assessments and leading quality improvement initiatives.
Key Responsibilities:
• Execute assessments and release processes for clinical supply
• Manage quality agreements and compliance reports
• Oversee quality lifecycle of GMP suppliers
• Lead investigations into quality issues and implement CAPA
• Serve as Quality Point of Contact for development teams
Requirements:
• Advanced degree in life sciences or equivalent
• Significant experience in GMP quality operations
• Stron...