Quality Management System Lead

Qualifications

• Bachelor's degree in Life Sciences, Quality, or related discipline required
• Quality-related certification preferred (e.g., ASQ, ISO Lead Auditor)
• Training in electronic QMS platforms advantageous
• 8-12 years of experience in Quality Assurance or Compliance
• Hands-on experience managing QMS in regulated GxP environments
• Experience in supporting QMS-related inspections and audits
• Strong communication and training skills.

Responsibilities

• Define and maintain QMS structure including policies and SOPs
• Ensure harmonization across GxP domains and compliance with regulations
• Oversee document lifecycle management from authoring to archival
• Ensure adherence to change control processes and QMS changes
• Oversee GxP training framework and compliance reporting
• Establish metrics for QMS health and reporting
• Lead initiatives to simplify and optimize QMS processes.

Benefits

• Comprehensive training programs
• Opportunities for professional development
• Collaborative work environment
• Emphasis on process improvement and innovation
• Supportive team culture focused on quality and compliance.