Job Description

The Associate Director, Quality Operations reports to the Associate Director, QA Operation Schachen Biologics and supports clinical quality activities at our Werthenstein site. They will have accountability for Good Manufacturing Practice (GMP) compliance, ensuring clinical supply functions operate within GMP requirements and compliant clinical drug substance. Driving and supporting compliance-based programs and results which include support and leading cross functional projects, solving complex problems, current Good Manufacturing Practices (cGMP) quality initiatives, quality system improvements, quality directives, compliance metrics and monitoring, Standard Operating Procedure (SOP) management and site procedures.

Essential Duties and Responsibilities:

• Responsible for the management, execution and leadership of quality activities to ensure compliance with cGMPs, applicable worldwide regulations and our company’s requirements...