Quality Assurance Manager
6 days ago
We are seeking a highly experienced Quality Assurance Manager to lead our team in ensuring product quality and reliability throughout the development lifecycle.
- This role requires strong leadership skills, with experience in developing and implementing validation strategies and processes in compliance with regulatory standards (e.g., FDA, ISO) and industry best practices.
- The successful candidate will collaborate with cross-functional teams to define validation requirements and priorities, establishing validation plans, protocols, and procedures.
- They will oversee the execution of validation activities, including IQ/OQ/PQ, software validation, and process validation, reviewing and approving test scripts based on objective evidence.
- A key aspect of this role is performing risk assessments and developing risk mitigation strategies, as well as driving continuous improvement initiatives to enhance validation processes and increase efficiency.
- Additionally, the Quality Assurance Manager will manage relationships with external vendors and contractors as needed for validation testing services, ensuring end-to-end documentation and traceability of validation activities.
Responsibilities:
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