Job Description

社名
社名非公開

職種
品質マネージャー, ディレクター, ヘッド

業務内容
Lead quality assurance initiatives and build a high-performing team in a dynamic pharmaceutical environment.About the companyOur client is a global leader in pharmaceutical manufacturing, committed to delivering high-quality products and fostering a collaborative work environment. They value innovation and continuous improvement, offering excellent career development opportunities for ambitious professionals. This role is based in the manufacturing facility.Role & ResponsibilitiesYou will be responsible for establishing and maintaining a robust quality management system, ensuring compliance with all relevant regulations and guidelines. You will lead a team of quality professionals, providing guidance and mentoring to foster a culture of excellence. You will play a key role in assuring product quality, managing batch disposition processes, and collaborating with cross-functional teams to ensure timely product release. You will also oversee the management of deviations, quality defects, CAPAs, and change controls.Main tasks include- Establish and maintain the quality organization to meet objectives and responsibilities.- Train and develop team members through coaching and performance management.- Determine resource needs (manpower, materials, etc.) for the team.- Assure product quality and manage batch disposition.- Collaborate with SCM and PET for timely batch release.- Manage deviations, quality defects, CAPAs, and change control processes.- Approve validation-related documents.- Lead the implementation and alignment of the QMS with global and local requirements.- Develop and maintain QMS procedures, standards, and documentation.- Support new product launches in collaboration with project teams.- Manage the preparation of dossiers and ensure core GMP documents are up-to-date.- Facilitate and coordinate issues across multiple functions (global/Japan).- Deputize for the QA Director.- Ensure clearly defined roles, responsibilities, and reporting lines.If you are interested in this exciting opportunity, apply now. We look forward to hearing from you.#LI-Hybrid#LI-KN

求められる経験
■Requirements
- Experience in quality assurance within a pharmaceutical manufacturing environment
- Project management skills
- Masters degree or equivalent in business, operations, or quality management
- Knowledge of Quality Management Systems and relevant regulatory requirements (e.g., JPAL/GMP/GQP)
- Understanding of Quality Risk Management
- Excellent oral and written communication skills in English and Japanese
- Leadership capabilities

While experience with CMC and global GMP (FDA, EU) guidelines, and proficiency in various computer applications are considered beneficial, they are not mandatory for this position. We encourage applications from candidates who meet the core requirements and possess a strong work ethic and commitment to quality."

保険
健康保険　厚生年金保険　雇用保険

休日休暇
土曜日　日曜日　祝日

給与
年収1,400 ～ 1,800万円

賞与
-
雇用期間
期間の定めなし

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