募集職種

管理者・施設長  

雇用形態

正社員

仕事内容

・Designated Subject matter expert for a number of test methods/processes across multiple products ・Leads method transfer & validation of in-process, final product, and stability methods specifically focusing on new product introduction ・May own scheduling of assignments in consultation with manager. ・Independently develop, write, and execute methods, protocols, reports, and other related documents aligned with regulatory and corporate guidelines. ・Represent the department in product review boards and regulatory inspections (internal and external audits). ・May author responses to regulatory requests. ・Lead projects, CAPAs and deviations/ investigations and/ or continuous improvement efforts. ・Anticipate and perform complex troubleshooting and problem solving independently. ・May represent the department in regulatory inspections (internal and external audits). ・Train and mentor others on multiple QC test methods, processes and procedures. ・Perform other tasks as assigned. ・Owns and contributes to change controls. ・May act as delegate for laboratory management, as required. ・Perform release/stability testing for complex and non-complex methods on intermediate or finished product as required ・Identifies and escalates challenges & barriers to execution, suggests solutions, and lead remediation. ・Champion and foster a positive, supportive, and collaborative quality culture. ・Actively and positively participates or leads in Operational Excellence (OpEx) and Continuous Improvement (CI) initiatives in the team ・Complete all required tasks compliantly and safely while consistently and intentionally modeling company's values (Integrity, Accountability, Passion, Urgency, Innovation, and Inclusion). Key Job Competencies ・Advanced ability to understand, follow, interpret and apply Global Regulatory and cGMP requirements accurately and completely. ・Demonstrated advanced technical writing skills. ・High problem-solving ability/mentality, technically adept and logical. ・Excellent attention to detail and demonstrated organizational skills. ・Ability to communicate effectively with peers, senior leaders and stakeholders across multiple departments and sites also in English ・Demonstrated strategic & enterprise thinking ・Advanced ability to work independently in a fast-paced team environment, meet deadlines, and prioritize work from multiple projects. ・Advanced use and knowledge of LIMS, ELN and laboratory data analysis. ・Advanced mentoring, coaching, influencing, negotiating and personnel interaction skills. Role Specific Assignments: ・Lead analytical test method transfer for new product launch ・Lead alignment of CoA and test method of DP site with External Manufacturing or company sites for MRA application ・Lead introduction of analytical instruments ・Lead Continuous Improvement Initiatives and enhancement of GMP compliance in QC lab

給与

正社員：年収 8,000,000円〜12,000,000円

給与の備考

年収　　800万円～1200万円　経験により応相談

待遇・福利厚生

通勤手当：有

試用期間

3ヶ月

勤務時間

通常（実質労働時間との連動） 就業時間：00:00 ～ 00:00

休日

年間休日数：125 土日祝 年間有給休暇：入社半年経過時点10日　10日 ～ 20日 法定休暇：年次有給休暇、産前産後休暇、介護休暇

応募要件

・Bachelors Degree in a non-technical discipline with ≥13 years experience, or ・Bachelors Degree in a Scientific or relevant Technical area with ≥9 years experience, or ・Masters Degree in a Scientific or relevant Technical area with ≥7 years relevant experience, or ・PhD in a Scientific or relevant Technical area with ≥5 years relevant experience. ・Able to write, read, and speak English fluently ・An equivalent combination of education and experience, preferably in a regulated environment will be considered.

最終更新日：2026/4/14

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