Affiliate Quality Head

Job title:Country Quality Head

• Grade: L3-2
• Hiring Manager: Leila Kadi
• Location: Cairo - Egypt
• Travel required as per business need.
• Job type: Full time

About the job

Mission and Purpose:

Lead and manage the implementation and maintenance of the Country Quality system across Country organization, embarking all concerned country functions (responsible for GxP and health-regulated activities), ensuring that safe, efficient, quality products, information and services are made available to meet patients and customers’ needs.

Main responsibilities:

Management of Country Quality System:

• Implement, manage and control a Country Quality system for GxP and health-regulated activities, in compliance with Sanofi Policies and applicable local regulatory requirements,
• Lead and coordinate a network of country functions stakeholders involved in GxP and health-regulated activities and embark them to address all matters related to Quality, including the support to business and digital initiatives
• Enhance Quality culture & promote Quality mind-set into the country governance, working principles and ways of operating
• Ensure appropriate communication of key messages pertaining to Quality across the country organization, highlighting their possible business impact

Country Quality documentation management system:

• Organize a consistent management of Country Quality documents related to GxP and health regulated activities through the system in place, including the screening process for released global quality documents and local regulations to capture the requirements into Country Quality documents
• Provide guidance to country functions to develop / update their respective Country Quality documents and related training modules
• Ensure that required owned quality documents are in-place, in-use and up to date at country level, and provide oversight of GxP areas
• Assure that a process for management of GxP documents and records is in place, considering data integrity principles

Country Quality audits and GxP regulatory country inspections:

• Provide support to ensure continuous audit and country inspection readiness, in particular through the use of the Inspection Readiness Tools for Country Organization.
• Manage country regulatory inspections related to owned GxP processes ensuring contribution of concerned Global functions, as needed, and provide support to other country GxP functions for their respective country regulatory inspections. Assure that these are reported by the relevant GxP function in the appropriate system.
• Where required by local regulation, in conjunction with Regulatory Affairs, support the Health Authorities in their GMP inspections of foreign sites. If required, and as agreed by the quality line management, accompany the inspectorates on their site visits
• Define and implement a strategy for audits of key local GxP and health-regulated subcontractors directly managed by the country and assure the coordination of the execution of these local audits
• According to local specific needs and regulatory requirements, enroll and complete the Sanofi auditor certification program to conduct local audits
• Evaluate trends in local quality audit findings that may affect the Country Quality system and communicate audit findings that require improvement to the appropriate function.
• Act as the primary country contact for GxP system quality audits by the Global Quality Audit team and remain up to date on related reports, including any conclusions, decisions made, as well as actions plans.

Training:

• Organize and manage information sharing, training sessions or programs related to processes under the responsibility of the CQH for concerned country associates, according to Sanofi standards and regulatory requirements.
• Ensure that there are system, process and procedure in place for the management of GxP & health-regulated trainings across the country by each GxP & health-regulated Function (CQH oversight on trainings owned by GxP & health-regulated Functions)

Country Quality Review:

• Carry out an annual Country Quality Review and organize the related meeting to present the outcomes to Country Senior Management, as per global Sanofi requirements and monitor the related Quality Program and Action Plan follow-up

Deviation and Corrective-Preventive Actions (CAPA) management:

• Define and implement a process to timely manage deviations and CAPAs related to all GxP and health-regulated activities, including those related to audits and country inspection findings, across the country in a consistent manner, and train concerned associates accordingly

Change Control management:

• Set a process to manage proposed changes that may impact GxP or health-regulated process or operations by leading multidisciplinary exchanges, implementing risk assessment and action plans when necessary.

Country Quality Performance Indicators (QPI):

• Monitor and periodically report country QPIs defined by Global Quality using the appropriate Global Quality computerized system. In addition, define and follow-up on local QPIs, when relevant

Country Quality Agreements:

• Ensure that valid and signed quality agreements (with the country as contract giver) are in place with the appropriate Sanofi manufacturing and distribution sites and/or external organizations for all GDP/GMP activities under the responsibility of Quality within the country organization

Other service agreements:

• Ensure that quality clauses are in place in service agreements for all subcontractors of GxP and health-regulated activities

Quality oversight of locally managed GxP subcontractors and local products distribution model:

• 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 country functions, as appropriate

Quality event/ risk management:

• Ensure that quality events and proactive/ reactive quality risks are properly managed within the country according to defined processes and standards (identification, assessment, control, communication)
• Provide risk management expertise to other country functions as appropriate

Administrative records:

• Liaise with each concerned GxP country function to ensure the availability of up-to-date administrative records (e.g. CV, job description, training log) for GxP positions and updated department organizational charts

Computerized systems/ digital projects:

• Ensure the maintenance of an up-to-date local inventory, together with relevant IS functions, and that local computerized systems/digital initiatives or in use within the country for GxP activities follow regulations and standards
• Provide inputs to business / as a Permanent member of Digital Governance Committee from Quality requirements perspective.

Management of Quality of products:

Product technical complaint:

• Manage product complaints received from the market according to Sanofi processes, standards and appropriate tools in force, in connection with the concerned Global Quality functions and local regulation
• Conduct product complaints trend analysis and signal detection, as appropriate.

Management of Incident reporting/ temperature excursions:

• Depending on country organization, ensure quality oversight on management of product distribution issues.

Other Product-related quality events:

• Escalate product-quality events as necessary occurring at the country level according to defined processes and standards and manage subsequent quality and product alerts (as appropriate).
• Coordinate product recalls as per global process.
• Provide support on Quality matters to the appropriate functions at country level and according to the defined responsibilities vis à vis Regulatory Authorities (e.g. Qualified Person, Regulatory Affairs to manage notification and communication with Regulatory Authorities for product related quality events).

Management of Country Batch release

• Perform local market batch release/ batch disposition in coordination with local health authority as appropriate.

Managerial tasks

• Ensure Country quality budget is adequately set up and monitored.
• Set Country Quality priorities in alignment with Global department priorities, as well as country business priorities.
• Evaluate continuously qualified resources are available to ensure Country Quality activities are properly executed.
• Manage Country Quality team, ensuring effective talent management through development, succession plans and adequate level of training (technical and soft skills) is maintained.

About you

Experience: Minimum of 06 years of experience in Quality Assurance activities, or  Health regulated activity (Regulatory, Pharmacovigilance, Medical excellence), with Practical GMP/ GDP experience and/or Sound knowledge in GxP, local health regulations like, industry guidelines including GCP and other industry standards.

Soft skills:

• Ability to work transversally in a matrix organization and business partnering, fostering a process simplification approach while meeting compliance with requirements
• Strong leadership skills, with appropriate level of flexibility.
• Easy & quick adaptation to variable situations requiring analysis, evaluation, thoughtful risk taking and decision making,
• Autonomy with confirmed sense of urgency, priorities & self-control, Pragmatic and well-organized
• Open-minded & result-oriented team player, customer oriented
• Solid Communication/information skills (towards affiliate Management, Global counterparts, local health authorities and managed service providers)
• Ability to interact efficiently with Competent Authorities/ Inspectorates
• Team management.

Technical skills:

• Knowledge of relevant Regulations, Guidelines, both national, regional, and international applicable to affiliate operations, Good Manufacturing Practice (GMP), Good Distribution Practice (GDP) and pharmaceutical legislation,
• Quality Management System
• Quality Risk Management
• Deviation & CAPA management
• Audit & inspection

Education:

Pharmacist or Degree medical field

Languages: Fluent in English