external manufacturing qa manager - 外資系製薬メーカー.

Lead quality oversight for a strategic CMO, ensuring compliance and driving continuous improvement within a dynamic global pharmaceutical company.■About the companyOur client is a leading global pharmaceutical company with a strong commitment to quality and innovation. They offer a collaborative and supportive work environment with opportunities for professional growth and development.■Role & ResponsibilitiesYou will be the key point of contact for quality oversight of a strategic Contract Manufacturing Organization (CMO), ensuring all activities meet the highest quality standards and regulatory requirements. You will build strong relationships with the CMO, leading quality reviews, managing deviations, and driving continuous improvement initiatives. You will also contribute to the broader quality system of the External Manufacturing & Supply (EM&S) team. This is a highly impactful role where you will directly influence the quality of pharmaceutical products and contribute to patient safety.■Main tasks include・Lead quality agreement updates with the CMO.・Oversee and manage CMO audits and regulatory inspections.・Develop and implement corrective and preventive actions (CAPAs).・Manage and analyze key performance indicators (KPIs) related to CMO performance.・Lead periodic quality reviews with the CMO.・Support deviation management and investigations.・Manage change control processes with the CMO.・Contribute to risk management and mitigation planning.・Support stability program oversight and data analysis.・Ensure CMO compliance with regulations and company directives.If you are interested in this exciting opportunity, apply now.We look forward to hearing from you.#LI-Hybrid

求められる経験
■Requirements
・Ph.D. in Pharmacy or Chemistry
・10+ years of experience in pharmaceutical manufacturing or QA/QC
・Extensive experience in GMP/GQP compliance
・Expert knowledge of deviation management and CAPA processes
・Strong understanding of quality risk assessment (QRA)
・Experience with regulatory inspections
・Fluency in English and Japanese

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1,000 ～ 1,600万円

賞与
-
雇用期間
期間の定めなし