Senior Quality Engineer, Leiden, Zuid-Holland

The Company
A global organization in the pharmaceutical and biologics manufacturing sector, focused on maintaining high-quality standards, regulatory compliance, and continuous improvement across production processes. The company operates in a highly regulated environment with a strong emphasis on innovation, patient safety, and operational excellence.

Role Description
The Senior Quality Engineer acts as an Investigation Owner, leading complex quality investigations across manufacturing operations. The role focuses on identifying root causes, driving corrective and preventive actions, and ensuring compliance with regulatory and internal standards. You will collaborate cross functionally, oversee quality records, and contribute to continuous improvement initiatives. This position is ideal for a seasoned professional with strong analytical thinking and leadership capabilities.

Responsibilities
- Lead nonconformance investigations including CAPA and change control activities from initiation to closure.
- Apply expertise in quality requirements to manage and support quality records.
- Review and approve documentation related to manufacturing processes and operations.
- Ensure accurate, compliant, and timely completion of quality records.
- Maintain and update procedures aligned with regulatory and internal requirements.
- Drive risk mitigation strategies and continuous improvement initiatives.
- Conduct GEMBA walks to monitor GMP compliance and identify process improvements.
- Coordinate cross functional teams and lead investigation activities.
- Escalate risks related to product quality, safety, and regulatory compliance.
- Oversee team outputs, ensuring quality in root cause analysis and risk assessment.
- Manage workload, track record status, and coordinate extension processes.
- Communicate findings and progress to stakeholders and management.

Requirements
- Bachelor level degree in a relevant field.
- 7 to 10 years experience in quality engineering, investigation lead, or similar role within the pharmaceutical industry.
- Experience in biologics manufacturing preferred.
- Strong knowledge of GMP and quality systems.
- Strong stakeholder management and communication skills.
- Experience in workload coordination and team support.

Other Information
- Requires regular interaction with cross functional teams and stakeholders.
- Involves shop floor presence through GEMBA walks.
- Focus on compliance within a regulated pharmaceutical environment.

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