External Manufacturing Quality Manager

Company Overview
バイエル薬品は、医療用医薬品事業、コンシューマーヘルス事業から構成されています。



医療用医薬品
医療用医薬品部門では、循環器・腎臓・代謝領域、オンコロジー領域、眼科領域、婦人科領域、血液領域、画像診断領域に注力しています。

循環器・腎臓・代謝領域では、2型糖尿病を合併する慢性腎臓病の治療薬、不整脈の一種である心房細動における脳卒中の発症を抑える経口抗凝固薬をはじめ、慢性心不全、脂質異常症などの循環器疾患治療薬を提供しています。
オンコロジー領域では、大腸がん、前立腺がん、希少がんなどに対して分子標的治療薬やアルファ線を使用した全く新しい治療薬を提供しています。
眼科領域では、欧米や日本で増加している滲出型加齢黄斑変性などの網膜疾患の治療薬で患者さんの視力を守り、質の高い日常生活の継続をサポートしています。
婦人科領域では、子宮内膜症に伴う疼痛や月経困難症、過多月経、更年期障害に対する治療薬や避妊法といった、さまざまなライフステージに応じた女性のクオリティ・オブ・ライフの向上を支える医薬品を提供しています。
血液領域では、標準型および半減期延長型製剤といった2種類の遺伝子組換え型血液凝固第VIII因子製剤を血友病患者さんに提供しています。
画像診断領域では、造影剤や自動注入器および線量管理システムのほか、AI（人工知能）を用いた画像診断支援ソフトウェアおよび診断や治療のフローを統合・最適化するデジタルプラットフォームの開発にも取り組んでいます。




コンシューマーヘルス
コンシューマーヘルス部門では、赤ちゃんの「人生最初の1000日」に適切な栄養を届けるため、女性の妊娠準備と妊娠期間を支援するサプリメントに注力しています。また、生誕110年以上の解熱鎮痛薬「バイエルアスピリン」、アレルギー性疾患治療薬や膣カンジダ抗真菌薬を通じ、人々のQOL向上に努めています。

Job Description
•Assure and monitor the supplier and Bayer products quality and compliance vs current regulations in force and Bayer standards to assure the supply of finished goods and services.
•Be responsible for Quality assessment of Contract Manufacturing Organization (CMO) selection, qualification and phase-out according to Bayer standards.
•Act as Quality representative in front of main External Manufacturing (EM) stakeholders (Procurement, Operations, Technical, Supply) within the Leadership Teams. Ensure on time communication to Country Quality Divisions.
•Monitoring deviation, complaint and Out-of Specification (OOS) properly investigated at CMO site including root cause analysis.
•Be accountable for determination and implementation of Corrective and Preventive Actions (CAPA) and effectiveness checks ensuring continuous improvement of Bayer product and process.
•Evaluate, from a Quality standpoint, change controls at CMOs related to existing portfolio, Transfers and Projects Monitoring and Evaluation of PQRs.
•Perform regular update of Quality Agreements established with CMOs.
•Review and approve analytical validation protocols and reports, generated by third parties Support manufacturing / packaging process of existing and /or transferred/ new products manufactured at CMOs.
•Review process validation protocols and reports in collaboration with Bayer Technical Management functions by ensuring continuous Process Verification and Statistical Process controls run according to relevant Bayer and Health Authorities guidelines and that are properly reported by CMOs to Bayer.
•Collaborate with technical team to complete transfer activities at CMO site in an efficient and complaint manner.
•Provide Q inputs for product Innovation and Development, enabling New Product Development project (NPDs) launch in time.
•Assess and approve quotations related to Projects and NPD quality activities.
•Monitor stability study of Bayer products to ensure it performed properly at EM site or 3rd party servicer accordingly to approved stability protocols.
•Contribute during regular internal preparations for planned audits at CMO, to ensure that Audit and Inspections CAPA are properly and timely implemented;
•Review and approval of related Risk Assessments and control strategies. Establish risk mitigation plan in high risk CMO to prevent supplying interruption or critical quality issue.

Requirements
•At least 5 years quality management experience or audit experience, CMO Q management experience are preferred.
•At least 8 years of experience in pharmaceutical / life science industry preferably in OTC industry
•Knowledge in local regulation and GMP requirement of OTC products, food supplement product, Cosmetics and all other relevant quality assurance guidelines;
•Familiar with pharmaceutical site operation, include PTC, deviation, change control, and documents etc.,
•Agile learner with ability to anticipate needs and be pro-active;
•Cross-functional team Player with excellent communication and negotiation skills for international interactions;
•Demonstrate workload prioritization and time management;
•Strong flexibility to adapt to different business cultures;
•Ability to travel up to 30% of time;
•Strong analytical and problem-solving skills.

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