Manager Quality Assurance

Essential Responsibilities

On-Site Quality Oversight

• Plan, organize, and oversee on-site quality supervision activities to ensure GMP compliance and effective execution of procedures.
• Review and approve quality supervision documentation, ensuring timely identification, escalation, and resolution of quality issues.
• Review and assess original GMP records, including deviation investigations, change controls, and equipment malfunction documentation.
• Oversee and authorize in-process control (IPC) release activities in accordance with approved procedures.

Quality Investigations and CAPA Management

• Establish, organize, and maintain compliant processes for quality investigations and CAPA execution.
• Provide technical oversight, guidance, and review of deviation and customer complaint investigations conducted by investigators.
• Ensure investigations and CAPAs are completed on time, thoroughly documented, and effectively closed.
• Monitor and track CAPA implementation and effectiveness to drive continuous improvement of the quality system.

Batch Record Review and Product Release

• Establish and maintain procedures governing batch record review and product disposition.
• Ensure timely and thorough review of batch production and testing records, with prompt resolution of discrepancies.
• Organize and oversee product release activities, ensuring compliance with regulatory requirements while maintaining operational efficiency.

Cross-Functional Quality Leadership

• Act as a primary Quality interface with Operations, Quality Control, and Engineering functions.
• Facilitate cross-functional resolution of quality issues and provide GMP guidance to support operations.
• Report quality metrics, deviation and CAPA trends, and improvement initiatives to management.
• Provide quality and compliance input for cross-functional projects and process improvement initiatives.

Team Leadership and Resource Management

• Lead and manage on-site QA and Operations On-Site QA teams, defining roles, responsibilities, and performance expectations.
• Coach and develop team members to strengthen competencies in investigations, CAPA management, and GMP documentation.
• Assess workload and resource needs, adjusting staffing and priorities to ensure business and compliance requirements are met.