Position: CHC China Country Quality Head

About the job

As the head of Sanofi China CHC Affiliate quality team, China Country Quality Head (CQH) is responsible for the following key tasks/activities of China CHC Affiliate Operations.

Main Responsibilities:

• Define, implement, manage and control the CHC Affiliate quality system across the CHINA CHC commercial office, in compliance with CHC Global Quality Policy and standards and with local applicable regulatory requirements.
• CHC Affiliate Quality Documentation Management System:
  • Organize within the CHC Affiliate a consistent management of country quality documents related to GxP and health regulated activities
  • Implement a screening process of released CHC Global Quality Documents and of local regulations to capture the requirements that must be transcribed into CHC Affiliate Quality Documents
  • Provide guidance to CHC Affiliate Functions to develop or update local Quality Documents and related training modules in their respective domains

• CHC Affiliate GxP Regulatory Inspections
  • Manage CHC Affiliate regulatory inspections related to GxP processes owned by the CQH, and provide support to and coordination with other GxP affiliate Functions in country regulatory inspections for processes in their respective area of responsibilities, ensuring contribution of concerned functions at Global level (as needed)
  • Where applicable and required by local regulations and/or expectations of the local Regulatory Authorities, in coordination with CHC Affiliate Regulatory Affairs, support the Health Authorities in their inspections of foreign manufacturing sites
  • Provide support to ensure continuous audit and inspection readiness
  • Act as the primary contact for GxP quality system audits performed by CHC Global Quality Audits (GQA) within the CHC Affiliate and support CHC GQA in their audits preparation, conduct and follow-up
  • Define and implement a strategy for local audits based on risk management criteria, of key local GxP and health-regulated subcontractors directly managed by the CHC Affiliate. Assure the coordination of the execution of the audits managed at CHC Affiliate level
• Training: Ensure appropriate training to Quality Basics/Quality matters of the CHC Affiliate personnel
• Carry-out an annual CHC Affiliate Quality Review, including quality oversight on activities executed by CHC Affiliate GxP and health-regulated Functions, and monitor the progress status of the defined CHC Affiliate Quality program actions
•  Define and implement across the CHC Affiliate a process to manage deviations and CAPAs related to all GxP and health-regulated activities (including those related to audits and inspection observations), and ensure appropriate training of the CHC Affiliate personnel in scope

• Set up a process to manage the changes that may impact GxP or health regulated processes or operations by leading multidisciplinary exchanges, implementing risk assessment and actions plans when necessary

•  Monitor and periodically report CHC Affiliate Quality KPIs defined by CHC Global Quality (and any other additional relevant local quality indicator)

•  Ensure that valid and signed quality agreements (with the CHC Affiliate as Contract Giver) are in place (with internal CHC manufacturing sites, distribution centers and/or External Manufacturing hubs, CMOs, distributors) for all GMP/GDP activities under the responsibility of Quality within the CHC Affiliate organization; ensure that quality-related clauses are in place in services agreements for all subcontractors of GxP and health-regulated activities for CHC Affiliate

•  Ensure an appropriate quality oversight process of locally managed subcontractors for all GxP and health-regulated activities, either directly (being involved in selection process, qualification and performance of audits) or through coordination with the concerned CHC Affiliate Functions, as appropriate.
•  Ensure that quality risks are properly managed across the CHC Affiliate.
•  Escalate and manage the quality events occurring within the CHC Affiliate according to defined processes and standards.
•  Ensure the availability of up-to-date administrative records (e.g. CV, Job Description, Training log) for CHC Affiliate Quality positions as well as CHC Affiliate up-to-date organization charts; provide guidance ti CHC Affiliate GxP and health-regulated Functions to be compliant with this requirement.

Liaise with each concerned country function to

• Computerized Systems: Maintain an up-to-date local inventory of GxP computerized systems and GxP spreadsheets in use within the CHC Affiliate for GxP and health-regulated activities, and guarantee they are validated by the relevant ITS Functions in charge.
• Manage CHC Product Quality Complaints received by the CHC Affiliate and perform trend analysis.
•  Lead and coordinate CHC product batch recalls and ensure prompt execution of recall operations in coordination with other Functions within the CHC Affiliate, as per CHC Global Quality process.
• Ensure quality oversight on management of CHC product distribution issues including temperature excursions.
• Where applicable (as per local regulatory requirements):
  • Perform local Market Batch Release/Batch Disposition.
  • Ensure Quality oversight on local distributors (“Buy & sell CHC products” partners).
  • Manage notifications from and to local Health Authorities for CHC products-related Quality events in liaison with other CHC Affiliate Functions, as appropriate.
  • Where applicable, act as Pharmacopoeia liaison.

• Manage CHC Affiliate Quality budget
• As CHC Affiliate Quality Business Partner, foster Quality Culture across the Affiliate, interact closely with CHC Affiliate Senior Leaders to provide appropriate Quality input and agile support to local CHC business.

• As CHC Affiliate GDP/Wholesale Distribution Responsible Person:

Ensure that all the Wholesale distribution activities covered by the corresponding Wholesale Distribution License (WDL) are operated by the CHC Affiliate in full compliance with GDP requirements.

About you 

The responsibilities of the Wholesale Distribution Responsible Person are the following:

• Obtain the GDP/WDL license and maintain it up to date
• Ensure that a Quality Management System has been implemented and is maintained
• Focus on the management of authorized activities and the accuracy and quality of records
• Ensure that initial and continuous training programs are implemented and maintained
• Coordinate and promptly perform any recall operations for CHC products
• Ensure that relevant customer complaints occurring in the distribution channels are dealt with effectively
• Decide on the final disposition of returned, rejected, recalled or falsified CHC products
• Approve any returns to saleable stock
• Ensure that processes are in place in order to handle out of stock situations and associated communication to relevant parties, in coordination with other CHC Affiliate Functions (e.g. Regulatory Affairs, Supply Chain, Medical)
• Ensure that suppliers and customers are approved
• Ensure that CHC products are being distributed only to validated customers
• Approve any subcontracted activities which may impact on GDP
• Keep appropriate records of any delegated duties
• Ensure that self-inspections are performed at appropriate regular intervals following a prearranged program and necessary corrective measures are put in place
• Ensure that any additional requirements imposed on certain CHC products by China law are adhered to

EDUCATION

University degree or equivalent (e.g. Licenced Pharmacist) in Pharmaceutical Engineering, Bioscience, Chemistry, or relevant subjects.

EXPERIENCE & KNOWLEDGE

• 6 years plus working experience in pharmaceutical industry, preferable in MNCs
• 3 years plus leadership role in quality functions
• Experience in interacting with health authorities, industry associations
• Experience in affiliate (commercial) quality management
• Fluent in Chinese and English speaking and writing
• Project management experience

CORE COMPETENCIES

• Capability to work in highly matrix organization
• Strong interpersonal and influential skill
• “Can Do” attitude

Pursue progress, discover extraordinary

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