外部製造オペレーション担当/ External Manufacturing Operations

A global biopharmaceutical company is looking for an External Manufacturing Operations Sr. Manager. The chosen applicant will be responsible for overseeing CMOs that supply products.

Responsibilities:

• Manage relationships and performance of CMOs and Partners, primarily in Japan, ensuring they contribute to ES EMC Integrated Manufacturing Excellence metrics and strategic objectives
• Lead Virtual Site Operations Teams (VSOTs) and provide matrix leadership to team members, including ES Quality, PPLs, BSLs, supply chain planners, procurement and GTE project leads, and remain accountable for team results
• Manage global stakeholders, including Product Portfolio Leaders, Brand Supply Leaders, and Commercial and PGS leadership
• Manage P&L for a complex portfolio, including contract negotiations and external relationship management at CEO level with contractors
• Develop and execute manufacturing and supply plans to meet market demand and supply performance targets, including the supply of APIs, raw materials and components where appropriate
• Develop and execute tactical plans for continuous improvement of CMO shop floor performance in product quality, EH&S, compliance, customer service and cost
• Review deviations that impact or may affect product supply, ensure timely closure, and lead investigations when necessary
• Oversee timely execution of new product introductions, product changes, product enhancements, localisation and product transfer programs, and lead implementation teams where required
• Ensure product supply, quality, compliance and cost issues at CMOs are addressed using Operational Excellence tools and mobilising the necessary resources
• Collaborate with EH&S to ensure compliance with environmental, health and safety regulations and company requirements
• Ensure effective communication of key product supply issues with stakeholders, CM Site Leads and Vice Presidents, PGS PPLs and ES Leadership
• Partner with ES Quality to ensure CMOs comply with regulatory requirements, cGMPs, company Quality Standards and Standard Operating Procedures
• Manage the cost reduction program by identifying opportunities with CMOs, validating financial impact, ensuring opportunities are captured in the Long Range Plan and Operational Plan, and overseeing execution and implementation
• Meet or exceed annual budget cost reduction targets
• Maintain awareness of new sourcing opportunities and identify strategic sourcing partners for pharmaceutical product manufacturing, packaging and testing who share common vision and values with PGS
• Ensure compliance with Legal Requirements under the My Anti-corruption Policy & Procedures (MAPP) and related legislation, with appropriate documentation of compliance
• Support and actively participate in ES initiatives to drive the business and deliver key metrics
• Lead assigned projects and initiatives across the contractor portfolio, including serialisation, business continuity plans, supplier network collaboration and environmental sustainability

Requirements:

• Bachelor’s degree or above in Science, Engineering, Pharmacy, Economics, Business (MBA is preferred)
• More than 9 years of experience in Pharmaceutical Operations (especially in API, vaccines, sterile injectables or solid oral dose) Global Technology, Engineering and Launch (GTEL)
• Knowledge of pharmaceutical manufacturing processes and regulatory requirements
• Background in Supply Chain or Quality Operations (External Supply, Procurement, R&D, or Project Management experience is also highly desirable)
• Ability and willingness to travel
• Proficient in written and verbal Japanese and English

Preferred Requirements:

• Master’s degree coupled with significant pharmaceutical experience
• Familiarity with industry standards for Good Manufacturing Practices in drug product manufacturing operations.
• Strong understanding of Supply Chain discipline
• Excellent negotiation skills for managing essential contracts and agreements
• Experience using common AI tools, including generative technologies such as ChatGPT or Microsoft Copilot

About the Company:

An international biopharmaceutical company with a wide portfolio of products that support the treatment and prevention of various diseases. The company has been widely recognised for its medicines.

Keywords:

製薬, メーカー, サプライチェーン, 外資系

Job Ref: Y225RM