Associate Director, Quality Lead (Turkey)

About the role

BeOne is seeking an experienced Associate Director to lead the Quality function for its Turkish affiliate. Based in Istanbul, the role ensures the local Quality Management System complies with Turkish regulations and global standards, while acting as the Qualified Person for batch release.

Key responsibilities

• Design, implement and maintain the local QMS, covering deviations, CAPAs, change controls, complaints and recalls.
• Ensure end‑to‑end GMP and GDP compliance across all operations, including oversight of third‑party logistics providers and distributors.
• Serve as the single point of contact for quality matters with partners, manage Quality Agreements and support partner audits.
• Host regulatory inspections and internal audits, preparing documentation and follow‑up actions.
• Release batches as the Turkish Qualified Person/Authorized Person (Mesul Müdür) and manage returns, recalls and destruction.

Required profile

• Minimum 8 years experience as an Authorized Person (Mesul Müdür) in biotech or pharmaceutical companies.
• Fluent in Turkish and English with strong written and verbal communication skills.
• Proven ability to work independently and collaborate across regulatory, supply‑chain and commercial teams.
• Willingness to travel 10‑20 % domestically and regionally.

Required skills

• Hands‑on experience with quality management systems such as Veeva.
• Proficiency in compliance platforms like ComplianceWire.
• Deep knowledge of GMP, GDP and local Turkish pharmaceutical regulations.