Senior Quality Assurance Systems Specialist

📋 Description

• Serve as primary coordinator for external audits (regulatory authorities, customers).
• Plan, schedule, and manage audit activities across departments.
• Act as main point of contact for auditors during inspections.
• Ensure timely preparation of audit materials (SMEs, docs, facility readiness).
• Lead audit response activities and CAPA tracking.
• Own and manage the site GxP Training System and training compliance.

🎯 Requirements

• Bachelor’s or Master’s degree in Life Sciences, Engineering, or related field.
• 5+ years in QA within a regulated manufacturing environment (pharma/medical devices).
• Strong experience with external audits/inspections and training systems management.
• In-depth knowledge of GMP, ISO standards, and regulatory requirements.
• Strong organizational and project management skills.
• Excellent communication and stakeholder management abilities.

🎁 Benefits

• Global CRO with development opportunities.
• Quality-focused culture and strong professional development.
• Inclusive, diverse workplace.