Senior QA Manager, Specialty Lab - Study-Based Audits

CERBA HEALTHCARE; Rotterdam; On-site; EUR 90,000 - 130,000; Full time

Job summary

Cerba Research is seeking a Senior QA Manager, Specialty Lab to strengthen quality oversight across Netherlands specialty lab operations, working flexibly between Rotterdam and Rijswijk. You will contribute to our study-based auditing programme to ensure quality oversight keeps pace with scale and complexity of our specialty lab work.

You will review science, mentor QA Managers, and drive QA practice across ISO17025, ISO15189, ISO13485, ISO9001, GCP, GLP and related standards.

Qualifications

• 5+ years' experience in Quality Assurance and laboratory operations.
• Fluent in English; Dutch is an advantage.

Responsibilities

• Participate in, perform, and review audit findings and reports for study-based audits.
• Advise and mentor QA Managers, providing support for QMS findings and their resolution during audits.
• Perform internal audits and support, follow up on, and host external audits and regulatory inspections.
• Review proposed CAPA responses and ensure adequate resolution.
• Detect deviations, review root cause analysis, and follow up on timely resolution of deviations, CAPAs and effectiveness checks.
• Aid in the preparation of local and global management review and KPIs.
• Independently manage QA-related projects through to completion.

Skills

Quality Assurance

Auditing

Regulatory compliance

Lab operations

Mentoring

Cross-site coordination

Job description

Cerba Research is seeking a Senior QA Manager, Specialty Lab to strengthen quality oversight across Netherlands specialty lab operations, working flexibly between Rotterdam and Rijswijk. You will contribute to our study-based auditing programme to ensure quality oversight keeps pace with scale and complexity of our specialty lab work.

You will review science, mentor QA Managers, and drive QA practice across ISO17025, ISO15189, ISO13485, ISO9001, GCP, GLP and related standards.