QA PM II-Operations

Description

• Serve as the primary QA liaison for assigned external customers
• Manage quality processes including change controls, deviations, investigations, and CAPAs
• Lead Joint Quality Team meetings and track action items
• Review and approve investigation reports and root cause analyses
• Collaborate with internal teams such as MSAT, Manufacturing, Engineering, and QC
• Support customer audits and maintain compliance with data integrity principles
• Prepare and present customer metrics and KPIs

Qualifications

• Bachelor’s degree in a scientific field or equivalent experience
• Experience in GMP environments and Quality Assurance (5+ years preferred)
• Strong understanding of biotechnology manufacturing and project management
• Ability to analyze data, make sound decisions, and prioritize tasks
• Excellent communication and relationship-building skills
• Familiarity with cGMPs and regulatory requirements
• A proactive, detail-oriented approach with a commitment to quality