Associate Director, Quality Lead

This is a fully remote position, open to applicants in Turkey.

📋 Description

• Develop and implement the Local Quality Management System (QMS) for the Turkish affiliate.

• Ensure adherence to local regulatory standards and international quality benchmarks.

• Carry out the Qualified Person (QP) duties and provide oversight on quality governance.

• Supervise GMP and GDP compliance within local operations in Turkey.

• Evaluate and manage third-party logistics providers, distributors, and service personnel.

• Oversee Quality Agreements and assist in partner qualifications and audits.

• Align global Quality policies and Standard Operating Procedures (SOPs) with local regulatory standards.

• Facilitate and assist with regulatory inspections and internal audits.

• Maintain quality documentation and ensure inspection readiness for the affiliate.

• Address product quality complaints and manage quality activities related to artwork.

• Review and provide support for commercial and technical agreements.

• Assist with regulatory filings and variations from a quality standpoint.

• Execute Turkish Qualified Person/Authorized Person batch release responsibilities, contingent upon approval and readiness.

• Oversee returns, recalls, and destruction processes for the Turkish market.

• Support GMP quality inspections and BeOne internal audits as a Quality Assurance subject matter expert.

⛳️ Requirements

• Minimum of 8 years of experience as an Authorized Person (Mesul Müdür) in biotechnology or pharmaceutical companies.

• Proficient in both Turkish and English.

• Strong verbal, written, and interpersonal communication skills.

• Experience working with the Turkish Authorized Person within the affiliate.

• Familiarity with operating in an affiliate importer model.

• Experience with distributors, third-party logistics providers, and external service partners.

• Capability to establish, implement, and manage a local Quality Management System (QMS).

• Proficient in quality and learning management systems such as Veeva and ComplianceWire.

• Strong project management abilities.

• Experience collaborating across various functions, including Regulatory Affairs, Supply Chain, Commercial, Medical, and Global Quality teams.

• Excellent troubleshooting, critical thinking, and problem-solving skills.

• Ability to operate across diverse regions and cultures.

• Strong presentation and influencing abilities.

• Capable of supporting batch release responsibilities as a Turkish Qualified Person/Authorized Person (Mesul Müdür), subject to regulatory approval, organizational readiness, and business needs.

🏝️ Benefits

• Equal opportunity employment.

• Approximately 10%-20% travel.