About the job

Mission

- Lead and manage the implementation and maintenance of the CHC Affiliate Quality System (covering GxP and health-regulated activities) across the local CHC Commercial organization, to ensure that quality processes and activities in scope are executed in compliance with the CHC Global Quality standards and applicable GxP regulatory requirements.

- Secure delivery of safe, efficient, quality CHC products, information & services to ensure patients/customers safety and act as Quality Business partner to support business priorities.

- As Responsible Person, ensure GDP compliance of wholesale distribution activities within the CHC affiliate market place.

- Focal point of contact in front of the Competent Authorities for any CHC product quality/technical, GMP and GDP-related matter.

Potential Specific Domains

- GxP and health-regulated activities related to the development, manufacturing, distribution and commercialization of all CHC drug and non-drug products contained in the CHC Affiliate portfolio

- Collaboration and support to other CHC Affiliate GxP and health regulated Functions (Regulatory Affairs, Medical, Pharmacovigilance, Clinical, Supply Chain, etc.) and partnership with Business Functions across the CHC Affiliate.

Main responsibilities:

Key Contributions & Activities

• Define, implement, manage and control the CHC Affiliate Quality system across the 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 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 CHC Affiliate Country Quality Head and provide support to and coordination to other GxP Affiliate Functions in country regulatory inspections for processes in their respective areas 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.
• 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 Country Quality Review, including quality oversight on activities executed by CHC Affiliate GxP and health-regulated Functions, and monitor the progress status of the defined Affiliate Quality program actions.
• Define and implement across the CHC Affiliate a process to manage deviations & CAPAs related to all GxP and health-regulated activities (including those related to audits & inspection observations) and ensure appropriate training of the affiliate personnel in scope.
• Set up across the CHC Affiliate a process to manage the changes that may impact GxP or health-regulated process or operations by leading multidisciplinary exchanges, implementing risk assessment and action plans when necessary.
• Monitor and periodically report CHC Affiliate Quality KPIs defined by CHC Global Quality (and any other additional relevant local quality indicators).
• 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 GDP/GMP activities under the responsibility of Quality within the CHC Affiliate organization; ensure that quality-related clauses are in place in service 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 on 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 to CHC Affiliate GxP and health-regulated Functions to be compliant with this requirement.
• 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 products 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 recall 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/Disposition
  • Ensure quality oversight on local distributors (“Buy & sell CHC products” partners)
  • Manage notifications from and to local Health Authorities for CHC product related quality events in liaison with other CHC Affiliate Functions as appropriate
• As CHC Affiliate Quality Business Partner, foster quality culture across the CHC Affiliate, interact closely with CHC Affiliate Senior Leaders to provide appropriate quality input and agile support to local CHC business.
• Manage CHC Affiliate Quality budget.

• (When applicable) As Multi Country Organization (MCO) Quality Head:
  • Mutualize CHC quality activities at MCO level for the benefit of each CHC country part of the MCO.
  • Provide quality input and agile support to local CHC business in each country part of the MCO.

About you

Qualification: Pharmacist

Experience: Practical experience in Quality System Management in Health regulated industry. Knowledge & experience in Medical, Clinical or in pharmacovigilance domain. English Fluent. Practical GDP experience.

Technical skill set: GxP (namely GMP, GDP) and health regulated regulations, Quality risk analysis/ Quality risk management , Continuous improvement management, Quality Systems/Affiliate Quality management (commercial organization)

At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.