CHC COUNTRY QUALITY HEAD (CQH) ECUADOR
Sanofi is one of the mayor players in the pharmaceutical industry with a proven footprint in Vaccines, Consumer Health Care, and Primary & Specialty Care.
Do you wish to change patient lives? Are you prepared to use your excellent business and people skills? Innovation is part of your way of working?
Are you passionate about transformation and leading change?
In this Role
Lead and manage the implementation and maintenance of the Ecuador 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.
By delegation from the Technical Director / Qualified Person, ensure quality oversight and supervise GDP compliance of the reception, storage, transportation, distribution activities handled by the local Distribution sub-contractor and the commercialization of CHC products.
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 :
Define, implement, manage and control the Affiliate Quality system across the Ecuador 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 Global Quality Documents and of local regulations to capture the requirements that must be transcribed into Ecuador 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 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 Ecuador 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 Ecuador 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 Ecuador CHC Affiliate;
assure the coordination of the execution of the audits managed at Ecuador CHC Affiliate level.
Training : Ensure appropriate training to quality basics / quality matters of the Ecuador CHC Affiliate personnel.
Carry out an annual Ecuador CHC Affiliate Country Quality Review, including quality oversight on activities executed by Ecuador CHC Affiliate GxP and health-regulated Functions, and monitor the progress status of the defined Affiliate Quality program actions.
Define and implement across the Ecuador 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 Ecuador 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 Ecuador 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 Ecuador 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 Ecuador CHC Affiliate organization;
ensure that quality-related clauses are in place in service agreements for all subcontractors of GxP and health-regulated activities for Ecuador 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 Ecuador CHC Affiliate Functions, as appropriate.
Ensure that quality risks are properly managed across the Ecuador CHC Affiliate
Escalate and manage the quality events occurring within the Ecuador 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 Ecuador 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 Ecuador 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 Ecuador CHC Affiliate and perform trend analysis. Back-up the CQH from CHC affiliate in COLOMBIA, PANAMA and / or PERU CHC affiliate for the management of CHC Product Complaints
Lead and coordinate CHC product batch recalls and ensure prompt execution of recall operations in coordination with other Functions within the Ecuador CHC Affiliate, as per CHC Global Quality recall process.
Tracking of stability programs for locally manufactured CHC products.
Verification of the Annual Product Quality review for locally manufactured CHC products.
Ensure quality oversight on management of CHC product distribution issues including temperature excursions.
Support appropriate Ecuador CHC Affiliate Functions in accordance with defined responsibilities with respect to Regulatory Authorities (e.
g., Qualified Person, Regulatory Affairs to manage notification and communication with local Health Authorities for CHC product related quality events), Technical Management of Environmental processes according to regulations of Environmental Authorities and Sanofi standards
As 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 Ecuador CHC Affiliate Operational Quality budget.
Quality oversight & compliance with Good Practices for storage, transportation & distribution :
Carry out permanent supervision for compliance with the technical and legal aspects at the time of reception, storage, transport, distribution by the sub-contracted Third-Party Logistics (3PL) and commercialization of medicines and other products subject to sanitary control and surveillance, to ensure the quality, safety and efficacy of medicines and optimal storage conditions for CHC products
Perform local Market Batch Release / Disposition
Ensure quality oversight on CHC products distribution issues, manage and make decisions in case of temperature excursion during storage or transport.
Decide on the final disposition of returned, rejected, recalled or falsified CHC products; responsible to move the status of the batches from quarantine to release in the ERP
Approve any returns of CHC products to saleable stock
Coordinate and promptly perform any recall operations for CHC products
Ensure that relevant customer complaints occurring in the distribution channels are dealt with effectively
Local management of final disposal (destruction) of expired products, rejected, returned and damaged CHC products.
Ensure that suppliers and customers are qualified and 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
Physical presence at the 3PL one day / week
Management of qualification of local 3PL as per Quality Agreement dispositions and Global Quality standards applicable all across Sanofi group
Your competencies : To succeed in the role, we require candidates to have
Education : An undergraduate degree is required. A Graduate degree (Master’s or MBA) is a plus.
Experience & knowledge : To succeed in the role, we require candidates to have :
Practical experience in Quality System Management in Health regulated industry.
Knowledge of Good Storage Practices and Good Storage Practices, distribution and transportation
Practical GDP experience.
Meets local regulations for nomination of Responsible Person. (Pharmaceutical Chemist)
Authorizations from local authorities to exercise Technical Direction, or to be the substitute.
Knowledge & experience in Medical, Clinical or in pharmacovigilance domain.
Advanced level of reading, spoken and written Spanish and English
Competencies : Act for change with agilityCommit to customersCooperate transversallyBusiness PartneringCommunication skills (oral & written, English)
What makes this position unique?
Following our vision and purpose, we want to have a real impact in the society, not only from a health care point of view, but also considering other dimensions.
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.