About the Company
Our client is a global life sciences organization operating within a highly regulated manufacturing environment. With a strong focus on quality, compliance, and continuous improvement, the company is committed to delivering high-quality products while maintaining the highest regulatory standards. To support ongoing operations and quality initiatives, they are looking for an experienced Senior Quality Engineer (Investigation Owner) to join their Quality team.
Role Description
As a Senior Quality Engineer (Investigation Owner), you will lead complex quality investigations related to manufacturing processes, products, and quality systems. You will be responsible for driving root cause investigations, coordinating cross-functional teams, and ensuring timely closure of deviations, CAPAs, and change controls. In addition, you will provide oversight on investigation quality, support workload management within the team, and drive continuous improvement initiatives to strengthen compliance and operational excellence.
Key Responsibilities
- Lead and manage deviations, non-conformance investigations, CAPAs, and change controls from initiation through closure.
- Perform thorough root cause analyses and ensure effective corrective and preventive actions are implemented.
- Coordinate cross-functional teams to resolve quality issues and maintain compliance.
- Review and approve investigation documentation, risk assessments, and quality records.
- Ensure timely and compliant completion of quality records and associated documentation.
- Support escalation processes related to product quality, GMP compliance, and regulatory risks.
- Drive continuous improvement and quality risk mitigation initiatives.
- Perform GEMBA walks to assess GMP compliance and identify improvement opportunities.
- Monitor investigation status, workload distribution, and support management reporting.
Requirements
- 7+ years of experience in Quality Engineering, Quality Assurance, Investigation Management, or a similar role within the pharmaceutical industry.
- Experience leading deviations, investigations, CAPAs, and change controls.
- Strong knowledge of GMP regulations and quality systems within a regulated manufacturing environment.
- Experience performing root cause analyses and risk assessments.
- Experience within biologics or pharmaceutical manufacturing is preferred.
- Strong analytical, problem-solving, and decision-making skills.
- Proven ability to coordinate stakeholders and work effectively across multiple departments.
- Strong organizational skills with the ability to manage multiple priorities simultaneously.
- Fluent in English, Dutch is a plus.
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