- San José, Costa Rica
- Senior
Provide Quality Assurance leadership for qualification and validation activities related to equipment, facilities, utilities, and computerized systems operating in cGMP environments.
Responsibilities
- Provide Quality Assurance leadership for qualification and validation activities related to equipment, facilities, utilities, and computerized systems operating in cGMP environments.
- Serve as the Global QA representative on cross-functional engineering and project teams, ensuring quality and compliance expectations are integrated throughout project lifecycles.
- Review and approve commissioning, qualification, validation documentation, technical assessments, risk evaluations, and compliance strategies.
- Guide functional teams and provide expert direction on commissioning, qualification, computer system validation (CSV), and enabling qualification activities.
- Translate regulatory trends, inspection observations, and industry expectations into actionable quality improvements and compliance strategies.
Requirements
- Bachelor’s in engineering, Biological Sciences, Chemical Sciences, Biotechnology, or relevant experience