Quality QA Lead – CDMO – mytos

Key Responsibilities

• Lead and manage the Quality Assurance (QA) team within the CDMO operations.
• Develop, implement, and maintain the Quality Management System (QMS) to ensure compliance with relevant regulations.
• Oversee and participate in validation activities for manufacturing processes and equipment.
• Ensure adherence to Good Manufacturing Practices (GMP) and other applicable quality standards.
• Manage quality-related investigations, deviations, and CAPA processes.
• Support regulatory inspections and audits.

Requirements

• Proven experience in Quality Assurance within a CDMO or pharmaceutical manufacturing environment.
• Strong understanding of GMP and regulatory requirements.
• Experience with validation processes and documentation.
• Excellent leadership and team management skills.
• Familiarity with Quality Management Systems and continuous improvement methodologies.

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