GMP/GDP QA Specialist — Batch Release & Documentation

Rhythm Pharmaceuticals, Inc; Amsterdam; Hybrid; EUR 60,000 - 90,000; Full time

Job summary

Rhythm Pharmaceuticals, Inc. is seeking a QA Specialist to ensure quality and regulatory compliance during manufacture and distribution of clinical and commercial products in the Netherlands.

You will be part of the Technical Operations, GMP and GDP QA Group, supporting batch release documentation and quality records. The role reports to the Senior Manager Quality Assurance / QP and collaborates with QPs, cross-functional teams, and external GMP partners to maintain inspection readiness and

Qualifications

• Bachelor’s degree in Pharmacy, Pharmaceutical Sciences, Life Sciences, Biotechnology, Chemistry or related field.
• Minimum 3 years in pharmaceutical QA, manufacturing, document control or GMP/GDP environment (or 2+ years with Master’s).
• Strong knowledge of GMP and GDP principles and batch documentation.

Responsibilities

• Coordinate batch release readiness and documentation for IMPs and commercial products.
• Compile batch records, ensure documentation availability and timely disposition.
• Perform initial quality checks of batch documentation for accuracy and traceability.
• Manage routing, review and filing of GMP/GDP docs in electronic systems.
• Serve as main contact for external partner requests and internal stakeholders.
• Track deviations, CAPAs, change controls, temperature excursions and other quality records.
• Maintain supplier qualification docs and records for vendor lifecycle.
• Support quality metrics and routine data summaries for batch release and QA processes.
• Assist with audit and regulatory inspection readiness; retrieve documents and maintain records.
• Identify gaps in documentation and escalate to QA or QP as needed.
• Contribute to continuous QA process improvements.

Skills

GMP compliance

GDP compliance

Documentation control

QA batch release support

Cross-functional collaboration

Education

Bachelor’s degree in Pharmacy or Life Sciences

Tools

eQMS

EDMS

ERP systems

Microsoft Office

Job description

Rhythm Pharmaceuticals, Inc. is seeking a QA Specialist to ensure quality and regulatory compliance during manufacture and distribution of clinical and commercial products in the Netherlands.

You will be part of the Technical Operations, GMP and GDP QA Group, supporting batch release documentation and quality records. The role reports to the Senior Manager Quality Assurance / QP and collaborates with QPs, cross-functional teams, and external GMP partners to maintain inspection readiness and