Country Quality Head

Job Description

JOB PURPOSEQuality specialist will take the lead to implement and maintain the KSA Country Quality system , embarking all concerned country functions (responsible for Good Practices - GxP and health regulated activities), ensuring safe and efficient quality products, and information and services are made available to meet patients and customers? needs.KEY RESULTS / ACCOUNTABILITIES1.1 Management of the Country Quality system? Define, implement and control a Country Quality system for GxP and health-regulatedactivities from development to commercialization of all products and related GxP services, in compliance with Sanofi quality documents and standards, as well as applicable local regulatory requirements.? Enhance Quality culture & promote Quality mind-set into the country governance, working principlesand ways of operating.? Ensure appropriate communication of key messages pertaining to Quality across the country organization, highlighting their possible business impact.? Lead and coordinate a network of professionals designated in each country function involved in GxPand health-regulated activities and embark them to address all matters related to Quality, including thesupport to business and digital initiatives.? Assure that a process for management of GxP documents and records is in place in all GxP andhealth-regulated areas, considering data integrity principles.Country quality documentation management system:

• Ensure a consistent management of country quality documents related to GxP and health-regulated activities through an appropriate system.
• Implement a screening process for released global quality documents and local regulations to capture the requirements that must be transcribed into country quality documents.
• Provide guidance to country functions that need to develop or update country quality documents and their related training modules in their respective domains.
• Ensure that required quality documents are in-place, in-use and up to date at country level, providing oversight of GxP areas.

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 Organizations.

• Provide support in managing country regulatory inspections related to GxP processes and provide support and coordination with other GxP country functions in country regulatory inspections for processes in their respective areas of responsibilities, ensuring contribution of concerned functions at Global level, as needed.

• Assure that country inspections of GxP or health-regulated areas are reported by the relevant GxP function in the appropriate company global database.

• Support in defining and implementing a strategy for local audits, based on risk management criteria, of key local GxP and health-regulated subcontractors directly managed by the country. Assure the coordination of the execution of audits managed at country level.

• According to local specific needs and regulatory requirements, enrol 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 global functions.

• Ensure that local critical and major pharmacovigilance or safety related audit findings are managed as per global Sanofi requirements.

• Support Global Quality Audit teams in their preparation, conduct and follow-up of audits.

• Remain up to date on GxP system quality audit reports concerning the country, including any

conclusions, decisions made, as well as actions plans.Training:

• Organise and manage information sharing, training sessions or programs related to processes

under the responsibility of the Quality Head 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.Country Quality Review:

• Support SA and ME MCO Quality Head in carrying out an annual Country Quality Review and organising the related meeting to present the outcomes to Country Senior Management, as per global Sanofi requirements.

• Support in issuing the associated Annual Country Quality Review report and monitoring 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 & 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:

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

Country Quality Performance Indicators (QPI):

• Periodically report country QPIs defined by Global Quality using the appropriate Global Quality computerized system. In addition, define and report 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:

• 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 country functions, as appropriate.

Quality risk management:

• Ensure that quality risks are properly managed within the country (identification, assessment, control, communication).
• Provide risk management expertise to other country functions as appropriate.

Non-product related quality events:

• Escalate and manage the events occurring at the country according to defined processes and standards.

Administrative records:

• Ensure availability of up-to-date administrative records (e.g. CV, job description, training log) for Country Quality team, as well as updated Country Quality organizational charts- and provide guidance to GxP and health regulated areas be compliant with this requirement.

Computerized systems (CS):

• Maintain an up to date local inventory of GxP CS and GxP spreadsheets and guarantee they are validated by the relevant ITS functions. In addition, assure that non-ITS computerized systems in use within the country for GxP activities are validated by system owner and in compliance with regulations and standards.

Projects:

• lead and coordinate Quality projects. Provide Quality support to new business areas (e.g.

acquisitions & divestments) and implementation of digital initiatives, including e-tools.1.2 Quality of products1.2.1. Product complaintsManage product complaints received from the market according to Sanofi processes, standards and appropriate tools in force, in connection with the concerned Global Quality functions.

• Conduct product complaints trend analysis and signal detection, as appropriate.

1.2.2. Product-related quality events

• Escalate 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 vis Regulatory Authorities (e.g. Qualified Person, Regulatory Affairs to manage notification and communication with Regulatory Authorities for product related quality events).
• Ensure quality oversight on management of product distribution issues, including temperature

excursion.1.2.3 Other relevant Quality tasks

• Perform local market batch release (batch disposition), ensure quality oversight of distributors (buy and sell products partners), and any other quality activity deemed necessary as per country regulation.
• Assure that any local GMP/GDP activities (e.g. manufacturing, repackaging, storage, distribution,
• testing, etc.) are performed in accordance with applicable GMP and GDP regulations.
• Provide Quality oversight of local Contracted Manufacturing Organizations (CMO).
• Manage and make decisions regarding temperature excursion during storage or transport
• 1.2.4. Quality tasks related to Distribution centre and the Distributors:
• Ensure that Good Distribution Practices guidelines are maintained at the distribution centre and the Distributors.
• Carry out specific tasks related to the Quality management of the distribution subcontractor:

management of stock movements; supervising and ensuring compliance to quality standards and regulations.

• Checking of inbound/outbound temperature conditions and confirmation of release to market or blockage of goods. Reporting & follow-up on root causes of deviation and implementation of corrective actions/preventive actions in distribution center.
• Ensure that an appropriate process is in place regarding product protection (counterfeits), and management of parallel trade issues.
• Ensure that all shipments are made as per temperature requirements and release of the same.

Maintain Compliance

• Abide by the requirements of the internal Code of Ethics including but not restricted to maintaining high professional standards of conduct in line with the Company procedure with a duty of care to the reputation of the Company
• Assume the role of Scientific Office Incharge ( optional ) for the new CHC legal entity , Opella

Ethical Leadership

• Takes personal accountability to use personal experience and knowledge, as well as the training and tools provided by Sanofi, to maintain a good knowledge and understanding of all ethics and governance relevant to the role (Sanofi ( Opella ) Policies and Procedures and any relevant legal requirements) and demonstrate personal leadership in applying these to all work undertaken.
• Escalates any decisions, or seek the support of colleagues or management if personal knowledge and understanding is not at the level required to carry out any part of the role

Health, Safety and Environment ResponsibilitiesTo care for his/her own safety and wellbeing and the safety of others, and to co-operate with the company to ensure a safe place of work.? Employees are therefore expected to:Support and conform to Company HSE rules and procedures to ensure a safe, healthy, and pollution free work environment. Follow HSE guidelines and take all necessary measures applicable to effectively implement the ?HSE action plan (PASS)? in the work area and the activities. Follow the HSE rules and ?Act responsibly? to protect yourself and others from an injury and ill health conditions while at the work locations and/or while using road e.g traffic rules, emergency evacuation procedure, medical surveillance, healthy lifestyle, no smoking inside the office premises etc.KEY WORKING RELATIONSHIPSINTERNALCross Functional Collaboration with:

• CHC Global , regional and other TME Quality teams
• Regulatory
• Medical
• PV
• Supply Chain
• Customer Care

Occasional Contact with:

• Finance
• Marketing
• Public Affairs
• Legal
• Compliance
• HR

EXTERNALWould be expected to be involved with:

• Health Authorities
• Distribution centres
• Greater Gulf distributors
• CMOs

SKILLS, EXPERIENCE & KNOWLEDGE REQUIREMENTS

• Education Level: Bachelor degree in a Pharmaceutical field & holding valid practice license (SCFHS).
• Saudi National , based in Riyadh
• Experience:

Minimum 2 years in Pharmaceutical & Quality

• Skills:

Communication & interpersonal skills.Accuracy to details.Ability to work well in cross-functional teams.Presentation skills.Planning and organising skills.PLAY TO WIN BEHAVIOUR

• Stretch
• Take Action
• Act for Patients and Customers
• Think Sanofi First

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.

Keyskills :