技術系（機械設計・製造技術） - 製造オペレーター（技能職）
メディカル・バイオ - メディカルGQP・GMP・品質保証・品質管理

The Head of Manufacturing will lead end-to-end operations of an Oral Solid Dosage (OSD) pharmaceutical plant in Japan, ensuring compliance with GMP standards, efficient production scheduling and planning, and delivery of high-quality products. This leader will act as the bridge between the production floor and senior management, frequently engaging on the shop floor while also driving strategic planning, cross-functional collaboration, and regulatory readiness.

Key Responsibilities
1. Manufacturing Operations
• Oversee day-to-day OSD manufacturing (granulation, blending, compression, coating, encapsulation, packaging).
• Ensure strict adherence to GMP, GDP, data integrity, and safety standards.
• Approve and monitor MBR/BMR compliance and ensure error-free documentation.
• Drive continuous improvement to enhance yield, reduce cycle time, and improve OEE.
2. Production Scheduling & Planning
• Develop weekly/monthly production schedules in alignment with demand forecasts and SCM priorities.
• Optimize campaign planning and manage efficient product changeovers (Type A/B cleaning).
• Monitor “plan vs. actual” output daily, addressing deviations proactively.
• Manage plant bottlenecks (e.g., coating time, drying capacity) and balance across shifts and equipment.
3. Regulatory & Quality Compliance
• Act as primary manufacturing contact during PMDA and client audits.
• Ensure timely closure of deviations, CAPAs, and risk assessments.
• Support validation (process, cleaning, equipment) and tech transfer of new products.
4. Leadership & People Development
• Lead, mentor, and motivate production managers, supervisors, and operators.
• Promote a culture of accountability, safety, and quality.
• Conduct regular floor walks to ensure presence, engagement, and direct problem-solving.
5. Cross-Functional Collaboration
• Work closely with QA/QC for in-process checks, release testing, and audit readiness.
• Partner with Engineering for equipment availability, preventive maintenance, and capacity expansion.
• Collaborate with R&D/Tech Transfer for smooth introduction of new molecules.

■休日：完全週休二日制, 土, 日, 祝日, GW, 夏季休暇, 年末年始

Must-Have Requirements
•Bilingual fluency (Japanese & English) – written and spoken; able to communicate seamlessly with global HQ and local operators.
•Frequent presence on the production floor – a visible, hands-on leader.
•Proven track record (15+ years minimum, with 7+ years in leadership) in OSD manufacturing in pharma.
•Strong expertise in production scheduling, planning, and campaign management.
•In-depth knowledge of GMP, PMDA guidelines, and experience managing regulatory inspections.
•Excellent leadership, problem-solving, and decision-making skills.
•Bachelor’s or Master’s in Pharmacy, Pharmaceutical Technology, Chemical Engineering, or related field.

Good-to-Have Qualities
•Experience in multinational/CDMO/CMO environments.
•Familiarity with digital manufacturing tools (MES, SAP, eBMR).
•Exposure to Lean, Six Sigma, Kaizen methodologies.
•Prior experience with new plant setup, scale-up, or expansion projects.
•Strong presentation skills for client visits and business development support.

Personality & Behavioral Traits
•Hands-on leader who earns respect by presence on the shop floor.
•Strong cultural sensitivity and ability to lead a Japanese workforce while aligning with global stakeholders.
•Resilient and calm under pressure, especially during audits or production disruptions.
•Natural mentor and team builder – invests in operator training and morale.
•Detail-oriented yet strategic – balances compliance with long-term vision.

■職種未経験者：不可