Quality Assurance Manager

Role Overview

The QA Manager is responsible for maintaining high quality standards across operations, ensuring regulatory compliance, and driving continuous improvement initiatives. This role supports inspection readiness, oversees quality systems, and collaborates with cross-functional teams to meet organizational and regulatory expectations.

Key Responsibilities

• Develop, implement, and maintain quality assurance policies, procedures, and standard operating procedures (SOPs).
• Lead quality review discussions and track performance metrics, issues, and improvement initiatives.
• Ensure adherence to applicable regulatory requirements and industry standards.
• Plan and conduct internal audits and coordinate external or customer audits.
• Prepare teams for regulatory inspections and provide leadership during inspection activities.
• Manage quality systems including deviations, CAPA, change control, and documentation processes.
• Review and analyze quality data to identify trends, risks, and opportunities for improvement.
• Support root cause investigations and implement corrective and preventive actions.
• Drive quality improvement initiatives across teams using standardized tools and methods.
• Organize training programs related to quality systems, compliance, and best practices.
• Evaluate potential quality risks and develop mitigation strategies while maintaining risk tracking records.
  
  

Qualifications

Education

• Bachelor's degree in Engineering, Life Sciences, or a related discipline.
  
  

Experience

• At least 8 years of experience in the life sciences industry.
• Minimum 5 years working with Good Clinical Practice (GCP) within an FDA-regulated environment.
• Experience supporting regulatory inspections and managing customer or regulatory audits.
  
  

Preferred Certification

• Quality auditing or related professional certification.
  
  

Key Skills

• Strong knowledge of regulatory frameworks and clinical quality standards.
• Familiarity with GCP guidelines and relevant sections of U.S. regulatory requirements.
• Experience with Quality Management Systems including document control, change management, investigations, training, and CAPA.
• Ability to analyze quality metrics and interpret data for continuous improvement.
• Skilled in root cause analysis and development of corrective action plans.
• Experience in process auditing and quality system improvement.
• Capability to develop clear and structured procedures and documentation.
• Excellent communication and collaboration skills with the ability to influence teams toward quality compliance.
  
  

Work Requirements

• Ability to perform routine office and meeting-related activities including extended periods of sitting, typing, and reviewing documents.
• Occasional movement between meeting areas and the ability to handle light materials when necessary.