Senior QA & QP Leader - EU GMP & Clinical Supply

Rhythm Pharmaceuticals Inc.

Amsterdam

Hybrid

EUR 120,000 - 160,000

Full time

4 days ago
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Benefits offered by this job

Hybrid work model

Job summary

Rhythm Pharmaceuticals Inc. seeks an experienced Clinical and Commercial Qualified Person (QP) to ensure quality and regulatory compliance across the product lifecycle, including IMPs used in global clinical trials and commercial products.

The QP will certify batches and oversee supply chains in a hybrid model from the Netherlands, reporting to the Senior Director of QA GMP, GDP, RP & DP. The ideal candidate holds a Master’s degree in a life sciences field, has at least 5 years in QA/GMP with QP

Qualifications

  • Master's degree in pharmacy, industrial pharmacy, pharmaceutical sciences, biotechnology, biochemistry, or related life sciences.
  • Eligible and qualified to act as a Qualified Person under EU rules.
  • Minimum 5 years in QA/GMP/manufacturing with QP certification and batch release.

Responsibilities

  • Serve as designated Qualified Person for IMPs and commercial batches with EU/UK release decisions.
  • Prepare QP Declarations (QPDs) for IMPs and clinical trial applications.
  • Review and approve GMP documentation, batch records, and specifications.
  • Oversee clinical and commercial supply chains, including CMOs and labs.
  • Support inspections and audit readiness with QA guidance.
  • Lead or participate in root-cause investigations and CAPAs.

Skills

Independent decision making
Excellent communication
Stakeholder management

Education

Master's degree in pharmacy or life sciences

Job description

Rhythm Pharmaceuticals Inc. seeks an experienced Clinical and Commercial Qualified Person (QP) to ensure quality and regulatory compliance across the product lifecycle, including IMPs used in global clinical trials and commercial products.

The QP will certify batches and oversee supply chains in a hybrid model from the Netherlands, reporting to the Senior Director of QA GMP, GDP, RP & DP. The ideal candidate holds a Master’s degree in a life sciences field, has at least 5 years in QA/GMP with QP

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