Manager - Quality Assurance, Operations

Catalent seeks a Manager of Quality Assurance Operations for its Madison, Wisconsin biomanufacturing facility. This leadership role oversees QA team activities in a GMP-regulated environment, including process transfer, batch record review, and client quality management across advanced mammalian cell culture manufacturing.

Responsibilities

• Lead, develop, and mentor quality team members with clear performance goals and feedback
• Oversee compliance with CGMP and Quality Management System requirements across manufacturing operations
• Manage quality communications with clients and ensure alignment with customer expectations
• Oversee process technology transfers, master batch record reviews, and batch disposition activities
• Champion continuous improvement initiatives and coordinate cross-functional GMP training efforts

Requirements

• Bachelor's degree in STEM discipline plus minimum 9 years GMP QA operations experience
• At least 4 years of leadership experience in quality assurance operations
• Expertise in cGMP, ICH, FDA, and EMA compliance requirements across biologics processes
• Demonstrated ability to lead cross-functional teams and manage client relationships
• Strong technical communication skills for complex data interpretation and regulatory strategy
• Experience with change control, audit readiness, CAPA development, and continuous improvement