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Sanofi

Global pharma company; vaccines and R&D

Country Quality Supervisor

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

About the Job

Requirements

  • Experience in industrial or affiliate quality system management is preferred.
  • A university degree or equivalent in Pharmaceutical Engineering, Bioscience, Chemistry, or a relevant subject is required.
  • Fluency in Chinese and English reading, speaking, and writing is required.
  • Knowledge of GxP and health-regulated regulations, including GMP and GDP, is required at a basic level.
  • Knowledge of GxP and health-regulated regulations, including GVP and GCP, is required at a basic level.
  • Advanced knowledge of quality systems is required.
  • Advanced continuous improvement management skills are required.
  • Basic quality risk analysis knowledge is required.
  • Basic quality risk management knowledge is required.
  • Basic project management skills are required.

Responsibilities

  • Implement, manage, and control a Country Quality Management System for GxP activities from development to commercialisation of all products and related GxP services, in compliance with Sanofi requirements and applicable local regulatory requirements.
  • Oversee country GxP operations and compliance, including pharmacovigilance, regulatory affairs, market supply chain, and medical functions, through the quality management system, supporting post-market management, GSP/GDP quality management, and MAHD accountability.
  • Promote a quality mindset in country governance, working principles, and operating practices.
  • Communicate key quality messages across the country organization and highlight their potential business impact.
  • Ensure processes for management of GxP documents and records are used in all GxP areas, considering data integrity and data privacy principles.
  • Organize lifecycle management of Country GxP documents, excluding the Clinical Study Unit, using the global content management system.
  • Coordinate use of global documents or creation of country GxP documents across GxP functions based on the Advanced Content Template when required by regulations.
  • Collaborate to ensure country inspection readiness.
  • Manage country regulatory inspections related to GxP processes owned by the CQH and coordinate support from other country GxP functions for inspections of their respective processes, involving global functions as needed.
  • Collaborate with Regulatory Affairs, Pharmacovigilance, and other relevant departments to support inspections of marketing authorization holders, overseas sites, and MAHDs where required by local regulations or authorities.
  • Implement a risk-based local quality audit strategy for key local GxP service providers managed directly by the country, including outsourced hybrid processes with safety-reporting components.
  • Organize information sharing and training sessions or programs for country associates on processes under the CQH’s responsibility, in accordance with company and regulatory requirements.
  • Ensure systems, processes, and procedures are used for personnel qualification and management of GxP training by each country GxP function.
  • Support the Annual Country Quality Review when required by local regulations.
  • Ensure a consistent process is used to manage deviations and corrective and preventive actions related to country GxP activities in a timely manner.
  • Ensure a country-wide process manages proposed changes that may affect GxP processes or operations, including risk assessments and action plans when necessary.
  • Monitor MCO/country quality performance indicators defined by Global Quality using the appropriate global computerized system.
  • Ensure compliance with local self-inspection requirements and implement a self-inspection program that supports continuous improvement and GxP inspection readiness.
  • Ensure country quality risks are identified, assessed, controlled, and communicated; provide risk management expertise to other country functions as appropriate.
  • Escalate and manage non-product-related quality events occurring in the country according to defined processes and procedures.
  • Maintain an up-to-date local inventory of GxP computerized systems and digital properties, excluding the Clinical Study Unit; verify locally owned GxP computerized systems are validated according to Sanofi requirements and address identified gaps.
  • Collaborate on quality projects and provide quality support to new business areas, including acquisitions, divestments, and product launch readiness, as needed.
  • Screen released local regulations to identify requirements for country quality documents and ensure local processes and systems comply with China GxP regulations through gap assessment and corrective action.
  • Support quality-culture activities, including World Quality Week and the Greater China Quality Community.
  • Advocate for and support quality evolution, organizational modernization, and digitalization by introducing mature digital tools into quality operations.
  • Manage product complaints received from markets, including suspicious product cases when applicable, in coordination with the central PTC organization.
  • Analyze product complaint trends and detect signals in accordance with Sanofi requirements and local regulations, where applicable.
  • Manage market quality inquiries according to Sanofi processes, procedures, and tools in coordination with relevant Global Quality functions.
  • Escalate country-level product-related quality events as necessary and manage subsequent quality alerts and product alerts as appropriate.
  • Coordinate product recalls according to global and local processes, including mock recalls where applicable.
  • Establish, maintain, and implement quality processes for compliance with China MAH/MAHD post-market regulations, including annual product reports under China DAL, VAL, and MAH regulations; quality communication with manufacturing sites and global quality; product traceability; and interaction with China health authorities.
  • Manage validation activities that may affect GSP/GDP processes or operations by leading multidisciplinary discussions and action plans when necessary.
  • Perform supplier and customer certification.
  • Ensure distributor licenses and relevant information meet GSP requirements.
  • Provide quality oversight of distributors, product-buying and selling partners, and external wholesaler distributors.
  • Provide quality oversight of other activities required by country regulations, including quality control analysis, analytical transfers, reference standards management, and pharmacovigilance.
  • Ensure local GMP/GDP activities under CQH responsibility, including manufacturing, repackaging, storage, distribution, and testing, comply with applicable GMP and GDP regulations.
  • Make decisions regarding temperature excursions during storage or transport when locally managed distribution subcontractors are involved, depending on country organization.

Desired Qualifications

  • Experience in industrial or affiliate quality system management 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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