S

Sanofi

Global pharma company; vaccines and R&D

Sterility Assurance Lead

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours
Full-timeBeijing, ChinaNo salary listedIn-person

About the Job

Requirements

  • Five years of experience in sterility assurance and microbiological control within a pharmaceutical or biotechnology environment.
  • Experience managing compliance and Health Authority regulations, with in-depth knowledge of regulatory requirements and Good Manufacturing Practices, including Annex 1, FDA guidance, and Pharmacopeia requirements.
  • Expertise in technical aspects of low-bioburden and/or sterile manufacturing, including aseptic processes, aseptic process simulation when applicable, microbiological testing, and environmental monitoring.
  • Ability to understand the design, procedural execution, and monitoring needed for low-bioburden or aseptic processes and propose an adequate Contamination Control Strategy.
  • Knowledge of quality and technical regulations in a Good Manufacturing Practice environment.
  • Ability to establish and maintain effective working relationships with key site stakeholders and collaborate across the site.
  • Excellent written and verbal communication and presentation skills.
  • Proficiency in the local language and English.

Responsibilities

  • Develop and implement comprehensive sterility assurance and microbiological programs aligned with organizational strategy, vision, and objectives.
  • Develop and implement sterility assurance and microbiology strategies and procedures across the organization, covering environment, water, steam, gas, bio-cleaning, gowning, aseptic processes and practices, industrial supplies, and process qualification and validation.
  • Ensure products and processes comply with applicable sterility assurance and microbiology regulatory requirements and company quality standards.
  • Maintain a system to identify, track, and mitigate sterility assurance and microbiological risks.
  • Oversee production activities, including manufacturing technical support and best aseptic practices.
  • Work with the Quality and Validation team to oversee validation, qualification, and monitoring of methods, equipment, and the environment to ensure sterility assurance control.
  • Monitor metrics and data for sterility assurance and microbiological activities, identify trends and issues, and implement action plans.
  • Establish and monitor key performance indicators and metrics for sterility assurance and microbiological activities, and report on their performance and effectiveness.
  • Promote a culture of quality throughout the organization.
  • Identify and drive continuous-improvement initiatives and projects to enhance sterility assurance and microbiological activities.
  • Evaluate and recommend technologies, tools, and methods to enhance sterility assurance and microbiology.
  • Lead management reviews to assess the effectiveness of the sterility assurance and microbiological programs.
  • Lead and manage the sterility assurance and microbiology team, including hiring, training, coaching, professional development, and performance evaluation.
  • Interact with external bodies and Global Quality to promote knowledge and awareness of industry practices, including congresses, Communities of Practice, and Centers of Excellence.
  • Prepare for and participate in regulatory inspections and audits, providing sterility assurance and microbiology expertise.
  • Support collaboration between Digital, Quality, and technical functions to achieve functionality, compliance, and productivity for new solutions in sterility assurance and environmental monitoring.
  • Ensure environmental monitoring operations fulfill Good Manufacturing Practice requirements; prepare specifications and analytical test methods for routine monitoring of manufacturing areas.
  • Manage projects and continuous improvement, validation, and investigations in environmental monitoring and sterility assurance.
  • Support implementation of the Contamination Control Strategy and sterile-product manufacturing to prevent contamination; troubleshoot contamination or abnormal sterility-test results involving environmental monitoring, equipment, utilities, materials, products, and production-related validation.
  • Develop or assist in developing microbiological and environmental-monitoring assessment standard operating procedures to support routine operations, including environmental-monitoring and utility monitoring and testing.
  • Ensure monitoring complies with specifications, Pharmacopeia requirements, and current Good Manufacturing Practice; analyze results and ensure out-of-limit investigations are properly conducted.
  • Maintain close communication with other departments to support proper execution of the production plan.
  • Perform gap analyses between global requirements and local authority standards, and implement corrective and preventive actions related to environmental monitoring, the Contamination Control Strategy, and gowning.
  • Support clean-zone reconstruction, process optimization, personnel awareness, and utility control from contamination-control and microorganism-monitoring perspectives.
  • Participate in investigations of contamination or abnormal sterility-test results involving environmental monitoring, equipment, utilities, materials, products, and aseptic process simulation.
  • Support implementation of the Contamination Control Strategy.
  • Support site-level technical training on contamination control.
  • Participate as the sterility assurance representative in expert assessments of contamination-control-related change controls.
  • Participate in inspections as the sterility assurance subject-matter expert, answer auditors’ questions, and coordinate with production and engineering departments on sterility-assurance-related audit questions.
  • Follow company Health, Safety, and Environment policies and integrate requirements into daily work plans.
  • Participate in implementing the department’s Health, Safety, and Environment management targets and follow related rules, procedures, and technical action plans.
  • Regularly identify potential Health, Safety, and Environment hazards, develop action plans, and complete corrective actions on time.
  • Participate in departmental Health, Safety, and Environment education and assessments, and address employee feedback promptly.
  • Cooperate with Health, Safety, and Environment management to prevent accidents.
  • Conduct regular +QDCI meetings at all levels, consider HSE8 requirements, report Health, Safety, and Environment issues accurately and promptly, and implement corrective actions.
  • Participate in accident investigations, analyze root causes from a quality-management perspective, and propose related corrective and preventive actions.

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

Recently Posted Jobs

Explore more opportunities at Sanofi

See more jobs