Associate Director, Quality Lead Turkey

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 continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.

This role is responsible for the establishment and execution of the Local Quality Management System (QMS) for the Turkish affiliate, ensuring full compliance with local regulatory requirements and global quality standards. The position includes execution of the Qualified Person (QP) function and accountability for robust quality governance, regulatory compliance, and the highest standards of patient safety.

The role is based in Turkey, preferably Istanbul, and requires fluency in both Turkish and English. The Turkish affiliate operates as the Marketing Authorization Holder (MAH) and importer of pharmaceutical products. The scope includes quality oversight and management of multiple third‑party logistics providers (3PLs), ensuring compliant importation, storage, and distribution activities with on‑site batch release responsibilities.

Quality Responsibilities

• Design, implement, and maintain the Local Quality Management System (QMS) for BeOne Turkey in compliance with national regulations, international guidelines, and global quality standards, including governance of deviations, CAPAs, change controls, temperature excursions, complaints, and product recalls.
• Ensure end‑to‑end GMP and GDP compliance across all local operations in Turkey, including effective quality oversight, qualification, and ongoing management of third‑party logistics provider (3PLs), distributors, and service providers.
• Act as the single point of contact for all quality‑related activities for distributors and partners in the assigned territory, including management and maintenance of Quality Agreements and support for partner qualification and audits.
• Ensure continuous alignment between global Quality policies and local regulatory requirements, translating global standards and SOPs into effective and compliant local execution, and actively contributing to the development and review of Global Quality Standards to reflect local legal requirements.
• Serve as regulatory inspection and internal audit quality host for the Turkish affiliate, including preparation, execution, and follow‑up of inspections and audits.
• Maintain full accountability for affiliate quality documentation, ensuring accuracy, completeness, and inspection readiness.
• Manage product quality complaints for the Turkish market and provide support for artwork‑related quality activities, as required.
• Provide quality input, review, and ongoing support for commercial and technical agreements (e.g., Quality Distribution, Service, Master, Collaboration agreements), ensuring compliant content, implementation, and lifecycle management.
• Support regulatory filings and variations from a quality perspective, as required.
• Batch release responsibilities as Turkish Qualified Person/ Authorized Person role (Mesul Müdür), subject to regulatory approval, organizational readiness, and business needs.
• Oversee returns, recalls, and destruction management for local Turkish market
• Support GMP quality inspections and BeOne internal audits as QA subject matter expert

Other Qualifications:

• +8 years of experience as Authorized Person (Mesul Müdür) at biotechnological or pharmaceutical companies
• Dedicated, highly collaborative team player demonstrating strong ownership, accountability, reliability, and the ability to operate effectively across local, regional, and global stakeholders.
• Fluency in both Turkish and English, with excellent verbal, written, and interpersonal communication skills, and the ability to communicate clearly and professionally in regulatory, operational, and cross‑functional contexts, with strong attention to detail.
• Proven ability to work in close collaboration with the Turkish Authorized Person within the affiliate, ensuring effective coordination of quality and regulatory responsibilities.
• Demonstrated experience operating within an affiliate importer model, including close collaboration with distributors, third‑party logistics providers, and external service partners.
• Strong capability to establish, implement, and operate a local Quality Management System (QMS) fully aligned with local regulatory requirements and global quality governance expectations.
• High level of competence in quality and learning management systems, such as Veeva and ComplianceWire, with the ability to ensure data integrity, training compliance, and inspection readiness.
• Strong project management skills, with the ability to manage multiple priorities, timelines, and stakeholders in a dynamic and evolving affiliate environment.
• Highly skilled in cross‑functional collaboration, working effectively with Regulatory Affairs, Supply Chain, Commercial, Medical, and Global Quality teams.
• Demonst