Senior Manager, Quality Assurance

Role Overview

Lead and manage the Quality Assurance team and activities, including internal/external audit programs, Supplier Quality Management, and Annual Product Review. Ensure compliance with applicable SOPs, internal processes, and regulations.

What You Will Do

Provide leadership, guidance, and direction for the Quality Assurance team. Oversee key quality processes, develop and implement quality assurance policies and procedures, and track, monitor, and analyze key performance indicators (KPIs).

Why It Might Be a Fit

This role requires a strong understanding of GMPs, GCPs, ISO, and other applicable regulatory requirements. The ideal candidate will have leadership experience in a QA, laboratory, or production environment and excellent interpersonal, writing, and communication skills.

Requirements

• Bachelor’s Degree in a science or technical field
• Master’s Degree in a science or technical field (preferred)
• A minimum of 8 years’ experience in a regulated pharmaceutical or biopharmaceutical industry
• Leadership experience in a QA, laboratory, or production environment
• Quality Assurance experience in an operational or development setting
• Advanced knowledge of GMPs, GCPs, ISO, and other applicable regulatory requirements
• Strong understanding of and experience supporting functional areas of business
• Excellent interpersonal, writing, and communication skills
• Ability to organize and prioritize work to meet targeted timelines
• Ability to adapt to different technologies, work styles, and communication methods
• Experience with Microsoft Office applications and ERP systems