Senior QP: Clinical & Commercial GMP Release Expert

Rhythm Pharmaceuticals, Inc; Amsterdam; Hybrid; EUR 120,000 - 160,000; Full time

Job summary

Rhythm Pharmaceuticals, Inc. seeks an experienced Qualified Person (QP) to ensure GMP/GDP compliance across clinical and commercial products. Based in the Netherlands, you will certify IMPs and commercial batches, oversee supply chains, and support regulatory inspections.

Collaboration across Clinical Operations, Regulatory Affairs, and Supply Chain is essential. This role requires a Master’s in Pharmacy, EU QP eligibility, and 5+ years in QA/GMP with batch release experience.

Qualifications

• Master’s degree in pharmacy or related life sciences.
• Qualified Person under EU Directive 2001/83/EC (Article 49).
• 5+ years in QA/GMP with at least 1 year of direct QP certification and batch release.

Responsibilities

• Serve as designated QP for IMPs and commercial products in EU/UK.
• Prepare and sign QP Declarations (QPDs) for clinical trials.
• Certify clinical and commercial batches per EU GMP and Annex 16.
• Oversee supply chains from substance to distribution.
• Support inspections and audits by authorities and sponsors.
• Develop and approve GMP/GDP documentation and SOPs.
• Lead qualification, auditing, and oversight of CMOs and labs.
• Provide QA guidance to cross-functional teams and product launches.

Skills

QP certification

Quality Assurance

EU GMP knowledge

Clinical & commercial supply

Supply chain oversight

Contract manufacturers oversight

CAPA & deviations

Regulatory inspections

English fluent

Independent decision making

Education

Master’s degree in Pharmacy

Job description

Rhythm Pharmaceuticals, Inc. seeks an experienced Qualified Person (QP) to ensure GMP/GDP compliance across clinical and commercial products. Based in the Netherlands, you will certify IMPs and commercial batches, oversee supply chains, and support regulatory inspections.

Collaboration across Clinical Operations, Regulatory Affairs, and Supply Chain is essential. This role requires a Master’s in Pharmacy, EU QP eligibility, and 5+ years in QA/GMP with batch release experience.