Lead the design, implementation, maintenance, and continuous improvement of the site Quality Management System (QMS) to ensure compliance with applicable regulations and corporate quality standards.
- Own and continuously improve the QMS (policies, SOPs, work instructions, records) to align with cGxP expectations and corporate requirements.
- Lead CAPA, nonconformance, deviation, change control, complaint handling, and recall readiness processes; ensure timely investigation, root-cause analysis, and effective remediation.
- Develop and maintain a risk-based approach to quality (FMEA, QRM) and integrate risk management into product and process decisions.
- Oversee internal and supplier audit programs; plan, coordinate, and lead internal and external audits and ensure timely closure of findings.
- Support supplier qualification and ongoing supplier quality oversight, including audits, performance monitoring, and corrective actions.
- Bachelor’s degree in Life Sciences, Engineering, or related field; advanced degree preferred.
- Nice to have: Lean
- Nice to have: Six Sigma
- Nice to have: supplier quality management
- Nice to have: validation strategies