コマーシャル・クオリティヘッド

Job Details

＜職務内容＞

1. Qualify, manage, support and supervise assigned CMO and API suppliers aligned with the company’s Quality Management Systems and provide reports as required
2. Manage (initiate and investigate) all significant quality issues associated with Drug Products or Medical Devices originating from assigned CMO (complaints, deviations, recalls, counterfeits and product tampering, stability failures, etc.) appropriately and in a timely fashion
3. Support business development for new CMO projects including due diligence audits and CMO qualification

＜応募要件＞

1. 5 年以上の QA 経験（品質保証責任者の経験あれば尚良し）
2. CMO management 経験
3. リーダーとして Project Management を行ったことがある
4. 自ら中心となり海外との折衝交渉を日常的に行っている