募集職種

管理者・施設長  

雇用形態

正社員

仕事内容

Essential Functions and Responsibilities (includes, but are not limited to): The Associate director, Quality Control is responsible for: ・Ensures all analytical testing activities in the laboratory comply with cGMP as well as safety and environmental requirements. Ensures testing is completed in a timely and cost-effective manner to meet supply targets. Ensures quality systems are continuously reviewed and new requirements are identified with necessary action taken. Leads laboratory investigation in accordance with guideline and cGMP requirements. Implement robust and sustainable corrective and preventive actions in a timely manner. ・Ensures all analysts working in the laboratory receive the required cGMP, EHS and role-related training required to work safely and in compliance with regulatory requirement and as defined by their training matrix. Provides coaching and mentoring for personal and professional development of staff.Manages the transfer of analytical methods, specifications and development knowledge for the product from development sites and between supply sites. ・Ensures that the safety measures associated with chemical and equipment handling are satisfactory and in compliance with EHS requirements. ・Forecasts resource needs, prepares and manages laboratory capital and expense budgets. Ensure lab is operating within the approved budgets. ・Develops and continuous improvement framework within the team, identifies and implements projects. Actively supports site improvement programs to enhance compliance, productivity; and reduce cycle time, inventory and waste. ・The Associate director, Quality Control is also responsible for: ·       Strategize and lead key Quality initiatives per Hoshin deliverables ・Manage escalations and stakeholders for the respective operations, including financial targets and related efficiency and productivity KPIs for the overall team.

給与

正社員：年収 8,000,000円〜14,000,000円

給与の備考

年収　　800万円～1400万円

待遇・福利厚生

通勤手当：有 住宅手当：有

試用期間

3ヶ月

勤務時間

フレックスタイム制 フルフレックス（コアタイムなし）

休日

土日祝 年間有給休暇：年間20日間相当 法定休暇：年次有給休暇 特別休暇：夏季休暇、年末年始休暇

応募要件

Qualifications & Experience Bachelor’s degree in science/ Life Science, Analytical Chemistry, Pharmaceutical Science, Engineering or proven relevant experience. • Minimum 8 years of applied professional work experience in the quality operations/quality control in pharmaceutical manufacturing, with at least 3 years of people management experience. • Demonstrated experience in change and project management with ability to lead a cross functional high-performance team. •Strong scientific understanding of analytical methodology and knowledge of relevant regulatory standards and cGMP requirement. Personal Qualities •  Effective English and Japanese communication skills, both oral and written (mandatory). Ability to work effectively on cross- functional teams as a leader or a core member. •  Demonstrated people management skills and ability to influence /collaborate with stakeholders at senior levels. • Customer focus with strong business acumen and continuous improvement mindset. • Strategic and critical thinking mindset with a collaborative and problem-solving attitude. • Strong communication and interpersonal skills. • Passionate in coaching and mentoring with a focus on creating an inclusive culture. Accountability, Achieving Objectives, Adaptability, CAPA Management, cGMP Regulations, Compliance Analysis, Corrective Action Management, Deviation Management, Laboratory Information Management System (LIMS), Leadership, Manufacturing, People Leadership, Quality Control Management, Quality Manuals, Quality Risk Management, Regulatory Experience, Strategic Thinking, Team Management

最終更新日：2026/4/28

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