Quality Lead, Turkey – QMS & Regulatory Compliance

beigene; Turkey; On-site; TRY 1,000,000 - 1,600,000; Full time

Job summary

BeOne Turkey seeks a seasoned quality professional to lead local QMS, ensure GMP/GDP compliance, and execute the Qualified Person function. The role requires strong regulatory collaboration with distributors, 3PLs, and internal teams.

The incumbent will oversee audits, documentation, and batch release responsibilities as needed. The position is based in Turkey (Istanbul preferred) with fluency in Turkish and English, managing quality for imports, storage, and distribution while maintaining the

Qualifications

• +8 years of experience as Authorized Person (Mesul Müdür) in pharma/biotech.
• Fluent in Turkish and English with strong regulatory communication.
• Proven ability to coordinate quality/regulatory activities across stakeholders.

Responsibilities

• Establish and maintain Local QMS for BeOne Turkey compliant with regulations.
• Ensure GMP/GDP compliance across local ops, 3PLs, and distributors.
• Act as primary contact for quality activities with distributors/partners.
• Align global quality policies with local regulatory requirements.
• Lead regulatory inspections and internal audits as QA host.
• Maintain affiliate quality documentation and inspection readiness.
• Support quality aspects of commercial/technical agreements.
• Support regulatory filings from a quality perspective.
• Oversee batch release responsibilities as Turkish Qualified Person.
• Manage returns, recalls, and destruction for the Turkish market.
• Support GMP quality inspections and internal BeOne audits.

Skills

Authorized Person

Quality governance

GMP/GDP

Cross-functional teamwork

QMS implementation

Turkish-English bilingual

Project management

Tools

Veeva

ComplianceWire

Job description

BeOne Turkey seeks a seasoned quality professional to lead local QMS, ensure GMP/GDP compliance, and execute the Qualified Person function. The role requires strong regulatory collaboration with distributors, 3PLs, and internal teams.

The incumbent will oversee audits, documentation, and batch release responsibilities as needed. The position is based in Turkey (Istanbul preferred) with fluency in Turkish and English, managing quality for imports, storage, and distribution while maintaining the