Associate Director, Quality Lead

🔥 2 minutes ago

🇹🇷 Turkey – Remote

⏰ Full Time

🟠 Senior

👔 Director

👻 Ghost score 10%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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BeOne Medicines

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 2010

🧬 Biotechnology

🏥 Healthcare

💊 Pharmaceuticals

Biotechnology • Healthcare • Pharmaceuticals

BeOne Medicines is a global oncology company domiciled in Switzerland that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a portfolio spanning hematology and solid tumors, BeOne is expediting the development of its diverse pipeline of novel therapeutics through its internal capabilities and collaborations. With a growing global team of more than 11,000 colleagues spanning six continents, the Company is committed to radically improving access to medicines for far more patients who need them.

📋 Description

• Establish and execute the Local Quality Management System (QMS) for the Turkish affiliate • Ensure compliance with local regulatory requirements and global quality standards • Execute the Qualified Person (QP) function and provide quality governance • Oversee GMP and GDP compliance across local operations in Turkey • Qualify and manage third-party logistics providers, distributors, and service providers • Manage Quality Agreements and support partner qualification and audits • Align global Quality policies and SOPs with local regulatory requirements • Host and support regulatory inspections and internal audits • Maintain affiliate quality documentation and inspection readiness • Manage product quality complaints and artwork-related quality activities • Review and support commercial and technical agreements • Support regulatory filings and variations from a quality perspective • Perform Turkish Qualified Person/Authorized Person batch release responsibilities, subject to approval and readiness • Oversee returns, recalls, and destruction for the Turkish market • Support GMP quality inspections and BeOne internal audits as a QA subject matter expert

🎯 Requirements

• +8 years of experience as Authorized Person (Mesul Müdür) at biotechnological or pharmaceutical companies • Fluency in both Turkish and English • Excellent verbal, written, and interpersonal communication skills • Experience collaborating with the Turkish Authorized Person within the affiliate • Experience operating within an affiliate importer model • Experience with distributors, third-party logistics providers, and external service partners • Ability to establish, implement, and operate a local Quality Management System (QMS) • Competence in quality and learning management systems such as Veeva and ComplianceWire • Strong project management skills • Experience collaborating cross-functionally with Regulatory Affairs, Supply Chain, Commercial, Medical, and Global Quality teams • Strong troubleshooting, critical thinking, and problem-solving capabilities • Ability to work across multiple regions and cultures • Strong presentation and influencing skills • Ability to support batch release responsibilities as Turkish Qualified Person/Authorized Person (Mesul Müdür), subject to regulatory approval, organizational readiness, and business needs

🏖️ Benefits

• Equal opportunity employment • Approximately 10%-20% travel