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Sanofi

Global pharma company; vaccines and R&D

Head of Inspection - Fill & Finish

Machine & Process OperationConfirmed live in the last 24 hours
Full-timeBeijing, ChinaNo salary listedIn-person

About the Job

Requirements

  • A bachelor's degree or higher in pharmacy or biology is required.
  • At least 10 years of experience in quality or sterile production is required.
  • Knowledge of quality systems in the pharmaceutical or related industry is required.
  • A thorough understanding of manufacturing and aseptic processes is required.
  • Working knowledge of quality systems and regulatory requirements across multiple health authorities is required.
  • Fluent written and spoken English is required.

Responsibilities

  • Coordinate projects, planning, quality, and engineering resources to organize production at the required volume, quality, cost, and schedule; supervise production, personnel, and facilities to ensure compliance with China GMP and Sanofi regulations; and continuously improve safety, quality, cost, delivery, motivation, and environmental performance.
  • Improve sterile production compliance and quality assurance, promote Sanofi Manufacturing System execution, and advance lean manufacturing.
  • Organize, coordinate, track, and implement deviations, changes, validation, complaints, and global standards gap analysis.
  • Manage quality systems to drive continuous process-compliance improvement.
  • Implement Sanofi quality policies and objectives and ensure sterile production operations comply with quality requirements.
  • Ensure sterile production quality-improvement programs and projects are effective.
  • Perform the duties of the Inspection Process-Centric Unit lead, including responsibility for 24-hour Level 1 Operating Unit performance and setting daily, weekly, and monthly priorities.
  • Ensure SMS 2.0 standards are followed, including role cards, standard work plans, planning adherence, standard times, and asset-care activities.
  • Escalate improvement opportunities concerning assets, processes, and scheduling, and contribute to continuous improvement.
  • Attend and lead Level 1 and Level 2 meetings, including QDCI, continuous improvement, asset care, deviation management, and end-to-end flow meetings.
  • Review performance and contribute to upskilling PCU members.
  • Manage PCU production shift work across morning, middle, and night shifts.
  • Participate in product-transfer projects, including training and related validation execution.
  • Optimize production processes and improve equipment and systems to consistently supply high-quality production for commercial-operation preparation.
  • Improve compounding yield and filling and inspection equipment performance to ensure stable market supply.
  • Manage the production environment, processes, hygiene, and facilities to ensure compliance with the drug master file, standard operating procedures, and GMP requirements.
  • Review batch production records and submit them to Quality on time.
  • Execute equipment qualification and process validation according to the master plan.
  • Deliver required initial and ongoing training to production operators and adjust training content as needed.
  • Organize daily production meetings, coordinate shifts, and communicate with planning, quality assurance, maintenance, warehouse, and other functions to implement the production plan and meet plant service-level and bias targets.
  • Follow up on change-control and corrective and preventive actions for production-related deviations or complaints.
  • Develop necessary standard operating procedures and ensure their implementation and continuous improvement.
  • Implement SMS standards and continuously improve 5S, health, safety and environment, and waste minimization.
  • Report product complaints and adverse drug reactions according to standard operating procedures.
  • Participate in process optimization, equipment improvement, and technical innovation to improve overall equipment effectiveness and yield, implement SMS standards, and continuously improve 5S, health, safety and environment, and waste minimization.
  • Complete other tasks assigned by the department manager.

About the Company

Sanofi

Global pharma company; vaccines and R&D

Sanofi is a global pharmaceutical and biotechnology company that develops, manufactures, and sells prescription medicines, over-the-counter products, and vaccines. Its products span immunology, oncology, rare diseases, and vaccines, addressing unmet medical needs through a strong focus on research and development. Sanofi's core product model relies on large-scale R&D, strategic partnerships, and licensing to bring new therapies to markets, with revenue generated from product sales and collaborations. The company differentiates itself by leveraging its global reach, diverse portfolio, and emphasis on patient-centric solutions, safety, and quality to navigate regulatory environments in developed and emerging markets. The company’s goal is to improve health outcomes and quality of life for people worldwide by delivering innovative treatments and vaccines that meet unmet medical needs.

Company size
10,001+
Company stage
IPO
Headquarters
Paris, France
Founded
1973

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