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Sanofi

Global pharma company; vaccines and R&D

Coordinator Assurance Quality System & Training Lead

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

About the Job

Requirements

  • A bachelor's degree or higher in Biology, Chemistry, Pharmacy, or a related science field is required.
  • At least 2 years of relevant pharmaceutical industry experience is required.
  • Proficiency in Word, Excel, and PowerPoint is required.
  • Good English listening, speaking, reading, and writing skills are required.
  • A strong professional knowledge base is required.
  • A performance- and results-oriented approach is required.
  • Good communication and coordination skills are required.

Responsibilities

  • Ensure distribution and marketing activities for products operated by Sanofi entities in China comply with Sanofi Quality Policy, Quality Standards, and applicable regulatory requirements.
  • Manage quality processes and perform quality control activities defined in procedures, especially those established under current GSP/GDP regulations.
  • Provide quality support to innovation and business initiatives, including digital transformation projects.
  • Promote a quality culture and mindset across the organization and ensure compliance with global Sanofi standards and local Chinese regulatory requirements.
  • Assist in developing and implementing the annual training plan to ensure compliance with Good Manufacturing Practice (GMP) and company standards.
  • Help identify training needs and develop customized training plans.
  • Support managers in establishing courses across different areas.
  • Develop training materials with subject-matter experts to meet training needs and plans.
  • Deliver training sessions on specific topics to new and existing employees.
  • Evaluate training effectiveness using assessments, feedback, and performance indicators.
  • Support subject-matter experts in updating training materials to reflect changes in regulations, procedures, and best practices.
  • Lead continuous-improvement initiatives to enhance training materials and processes.
  • Support regulatory inspections and audits by providing training records, processes, and materials.
  • Contribute to training activities related to plant Quality Management System (QMS) processes, such as deviations, Corrective and Preventive Action (CAPA), and change control.
  • Own a designated quality process at the plant, including its processes, systems, and data.
  • Conduct routine data-quality checks and validations to identify and resolve process, system, or data issues.
  • Develop and implement training-plan principles and practices.
  • Identify and assess risks related to in-scope processes and implement mitigation strategies.
  • Lead site continuous-improvement initiatives in line with global processes and practices.
  • Oversee computerized systems related to processes and ensure they meet requirements.
  • Develop and monitor key performance indicators in accordance with global guidelines.
  • Represent the plant in globally led Communities of Practice (CoPs), participate in Centers of Excellence (CoEs) when requested, and ensure local communication.
  • Represent Sanofi Global Quality in interactions with health authorities concerning global processes.
  • Perform iLearn administration, including managing learning objects, groups, assignments, and dedicated reports, to support quality and Health, Safety and Environment (HSE) training needs within the role's authorization.
  • Determine the best way to operate learning courses in iLearn by applying approved ways of working.
  • Support managers and training specialists in developing training plans according to iLearn best practices and stay current with tool-functionality developments through timely completion of relevant training.
  • Maintain alignment with other decentralized administrators by attending regular coordination meetings.
  • Update and manage the training catalogue in iLearn.
  • Contribute to site projects that require Learning Management System (LMS) expertise.
  • Within granted authorization and applicable work instructions, create, modify, re-version, and deactivate designated learning content in iLearn, including e-learning courses, on-the-job training, and organized face-to-face or virtual training, following approved processes including testing in P2.
  • Request creation of non-Workday user profiles through the global request interface in accordance with iLearn user-profile requirements.
  • Manage groups, learning assignments, registrations, and completions in iLearn.
  • Run iLearn reports.
  • Contact the global iLearn operations team for activities outside decentralized-administrator permissions.
  • Use the global quality documents applicable to the role's iLearn operations, ensure activities are compliant, and respond to iLearn Quality Control requests for data updates and corrections.
  • Contribute to deviation investigations or analyses related to the tool or its interfaces with other tools, when needed.
  • Support audits and inspections by demonstrating tool operations and providing inspection reports as needed.
  • Provide Level 2 support to learners and contribute to improvements in learner support by enriching the knowledge base.
  • Participate in iLearn administrator development initiatives, including process improvement and testing.
  • Contribute as backup or support to decentralized activities at other plants or entities when needed.
  • Set and prioritize plant training objectives.
  • Advise department heads on training needs.
  • Determine training content and delivery methods.
  • Recommend improvements based on training evaluations.
  • Advise on continuous-improvement initiatives.
  • Establish and prioritize process evolution at the plant.
  • Support audits and inspections and demonstrate processes to auditors and inspectors.
  • Proactively identify remediation actions based on internal and external audit results under the control of global process owners.
  • Identify training needs and stay informed of inspection and audit results.
  • Translate business needs into iLearn operational processes, analyze requirements, communicate with requesters, and determine the best iLearn solution and configuration.
  • Determine tool training configurations based on managers' needs.
  • Set training designs based on subject-matter expert and entity training-service requirements, including sequence and due dates, to meet training expectations.
  • Comply with the General Data Protection Regulation (GDPR) and data-protection principles.
  • Perform other work as assigned.

Desired Qualifications

  • Experience in the biological-products field is preferred.
  • Training-related experience is preferred.

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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