GMP/GDP QA Specialist — Batch Release & Documentation

Rhythm Pharmaceuticals Inc.; Amsterdam; Hybrid; EUR 52,000 - 76,000; Full time

Job summary

Rhythm Pharmaceuticals Inc. is seeking a QA Specialist to ensure quality and regulatory compliance during manufacture and distribution of Rhythm products.

You will report to the Senior Manager Quality Assurance and collaborate with QPs, RPs, and cross‑functional teams across Technical Operations and Regulatory Affairs. The role focuses on maintaining inspection readiness, handling deviations, CAPAs, change controls, and document management across GMP/GDP processes.

Qualifications

• Bachelor’s degree in Pharmacy, Pharmaceutical Sciences, Life Sciences, Biotechnology, Chemistry, or related field.
• 3+ years in pharmaceutical QA, manufacturing, document control, or GMP/GDP environment (2+ years with Master).
• Good knowledge of GMP and GDP; familiarity with quality systems and batch documentation.
• Experience supporting document review, batch records, quality events, or batch release is an advantage.

Responsibilities

• Coordinate batch release readiness and documentation for IMPs and commercial products.
• Compile batch records, verify documentation availability, and follow up on missing information for timely disposition.
• Perform administrative checks of batch documentation for completeness, accuracy, traceability, and compliance.

Skills

GMP/GDP knowledge

Documentation control

Batch release support

EDMS/eQMS experience

English fluency

Education

Bachelor's degree in Pharmacy or Life Sciences

Tools

MS Office

eQMS software

Job description

Rhythm Pharmaceuticals Inc. is seeking a QA Specialist to ensure quality and regulatory compliance during manufacture and distribution of Rhythm products.

You will report to the Senior Manager Quality Assurance and collaborate with QPs, RPs, and cross‑functional teams across Technical Operations and Regulatory Affairs. The role focuses on maintaining inspection readiness, handling deviations, CAPAs, change controls, and document management across GMP/GDP processes.