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Customer Quality Partner

PlusOne - Biotech, Medtech, Hightech Talents · Braine-l'Alleud

جديد
Senior 🇬🇧 English
GMP Quality Agreements Product Quality Reviews CAPA

وصف الوظيفة

About the role

The Customer Quality Partner will serve as the senior quality liaison for an assigned portfolio of international pharmaceutical and biotech customers at PolyPeptide’s Belgian site. Reporting to senior management, this role ensures product quality and regulatory compliance throughout the development and commercial lifecycle while building trusted, fact‑based relationships.

Key responsibilities

  • Lead the QA relationship with assigned customers and act as the primary quality contact.
  • Provide proactive communication on deviations, delays, risks or sensitive quality issues.
  • Secure project and product quality governance from development through follow‑up.
  • Lead and approve Quality Agreements and oversee their implementation.
  • Coordinate and review Product Quality Reviews (PQRs) to ensure robustness and compliance.
  • Manage complex quality issues and complaints end‑to‑end, including root‑cause analysis and corrective‑preventive actions.
  • Present conclusions, decisions and action plans to customers in a factual and credible manner.

Required profile

  • Senior professional with extensive QA experience in the pharmaceutical or biotech sector.
  • Proven ability to manage high‑pressure situations with maturity, diplomacy and clarity.
  • Strong track record of building trusted relationships with demanding international customers.

Required skills

  • Good Manufacturing Practice (GMP) knowledge.
  • Regulatory compliance expertise.
  • Development and management of Quality Agreements.
  • Product Quality Review (PQR) preparation and review.
  • Root‑cause analysis and CAPA implementation.
  • Complaint handling and resolution.

Questions fréquentes

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PlusOne - Biotech, Medtech, Hightech Talents

Braine-l'Alleud