GxP Compliance Manager at Roche

Join Hoffmann-La Roche as a GxP Compliance Manager to guarantee quality oversight of CDMOs and CROs. Ensure compliance with cGMP and drive quality performance across clinical supply operations.
This senior role requires at least 8-10 years of quality experience in pharmaceutical or biotech sectors. You will leverage your expertise in the clinical product lifecycle, overseeing manufacturing processes from supply assessment to release. Collaborate cross-functionally with partners to enhance compliance and mitigate risks, ensuring top-tier quality throughout.
Key Responsibilities:
• Manage quality agreements and monitor cGMP compliance
• Lead resolution of complex quality investigations and risk assessments
• Execute quality activities throughout GMP supplier lifecycles
• Serve as the Quality Point of Contact for key partners
• Approve specifications and review regulatory submissions
Requirements:
• B.S., M.Sc., or PhD in life sciences or equivalent
• 8-10 ye...