Associate Director of Quality Assurance, Analytical and Client Services

The Associate Director of Quality Assurance, Analytical and Client Services is responsible for fostering a culture of quality, efficiency, and excellence, and ensuring quality and compliance are integrated into day-to-day operations. The role involves leading the Clinical Quality Assurance Department, implementing quality systems, and providing oversight of site activities.

Requirements

• Identifies and eliminates risk to continuously improve customer satisfaction and product reliability
• Leads and steers the Clinical Quality Assurance (QA) Department
• Leads implementation and continuous improvement of the company’s quality systems and facility validation
• Creates product quality documentation system
• Supports Analytical Services and Act as QA Liaison for Client Interactions/Projects
• Responsible for oversight of site activities, assuring that products are manufactured in compliance with cGMP, FDA, and EU guidelines
• Supports internal audits, client audits and regulatory inspections
• Provides support and oversight of Quality Management Review meetings
• Maintains product quality by enforcing quality assurance policies and procedures and government requirements
• Collaborates with other members of management to develop new product and engineering designs and manufacturing and training methods
• Prepares product and process quality reports by collecting, analyzing, and summarizing information and trends
• Defines and maintains a strong people management, training, and engagement culture to ensure a high and constantly improving right first-time rate in manufacturing and QC
• Manages the QA budget to ensure that resources are allocated appropriately and that all projects are completed on time and within budget

Benefits

• Over four weeks of paid time off annually
• Employer contributions to a retirement account
• Various health plans
• Basic life and long-term disability insurance
• Employee Assistance Program
• Pet insurance