Quality Lead, Turkey - Local QMS & QP Oversight

BeOne Medicines; Fatih; On-site; TRY 800,000 - 1,000,000; Full time

Job summary

BeOne Medicines is seeking an experienced QA leader in Turkey to establish and run the Local Quality Management System in alignment with local regulations and global standards. You will oversee 3PL quality, distributor collaboration, and be the Turkish Qualified Person for batch release where approved.

The role requires 8+ years as Mesul Müdür, fluency in Turkish and English, and strong cross-functional collaboration across regulatory, supply chain, and commercial teams.

Qualifications

• 8+ years of experience as Authorized Person (Mesul Müdür) in biotechnological or pharmaceutical companies.
• Fluency in Turkish and English with excellent regulatory communication skills.
• Proven ability to collaborate with Turkish Authorized Person and distributors/3PL partners.
• Experience in affiliate importer model and quality governance across local, regional and global stakeholders.
• Strong knowledge of local regulatory requirements and global quality standards.

Responsibilities

• Establish and maintain the Local Quality Management System (QMS) for BeOne Turkey in compliance with regulations and global standards.
• Ensure GMP and GDP compliance across local operations, 3PLs, distributors, and service providers.
• Act as the single point of contact for quality activities with distributors and partners in Turkey.
• Maintain Quality Agreements and support partner qualification and audits.
• Support regulatory filings and variations from a quality perspective.
• Batch release responsibilities as Mesul Müdür subject to regulatory approval.
• Oversee returns, recalls, and destruction management for the Turkish market.
• Support GMP quality inspections and BeOne internal audits as QA SME.

Skills

Authorized Person leadership

Cross-functional collaboration

Regulatory communication

Problem solving

Attention to detail

Tools

Veeva

ComplianceWire

Job description

BeOne Medicines is seeking an experienced QA leader in Turkey to establish and run the Local Quality Management System in alignment with local regulations and global standards. You will oversee 3PL quality, distributor collaboration, and be the Turkish Qualified Person for batch release where approved.

The role requires 8+ years as Mesul Müdür, fluency in Turkish and English, and strong cross-functional collaboration across regulatory, supply chain, and commercial teams.