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Quality Lead

Synthorx

Synthorx

Quality Assurance
Jeddah Saudi Arabia
Posted on Wednesday, October 4, 2023

Job title: Quality Lead

  • Location: Jeddah / Saudi Arabia
  • 30-40% Remote working and 20 % of travel expected.
  • Job type: Permanent, Full time

About the job

Our Team:

Greater Gulf Quality team covering all quality aspects within GG countries (Bahrain, Kuwait, Oman, Qatar, Saudi Arabia, and UAE) for all GBUs, dynamic and diverse team, working transversally with all functions especially Medical, Regulatory, PV, Supply Chain and Customer Care and externally with Health Authorities, Distribution centers, Greater Gulf distributors.

Mission and Purpose:

Quality Lead supports, works with the Greater Gulf MCO Quality Head to manage the implementation and maintenance of the Country Quality system across the multi-country organization,

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.

Quality Lead is the backup of the Greater Gulf MCO Quality Head in case of absence or leave.

Quality Lead is the local quality representative registered in Saudi Food and Drug Authority and will be responsible of all communication with them.

Main responsibilities:

Management of the Country Quality system

Provide support to the Greater Gulf MCO Quality Head in the Management of country quality system as applicable; including any of the following as directed by the Greater Gulf MCO Quality Head:

• Define, implement, and control a Country Quality system for GxP and health-regulated activities 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 principles and 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 GxP and health-regulated activities and embark them to address all matters related to Quality, including the

support to business and digital initiatives.

• Assure that a process for management of GxP documents and records is in place in all GxP and health-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, through the use of the Inspection Readiness Tools for Country Organizations.

• Manage country regulatory inspections in Saudi Arabia 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.

• 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 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:

• Organize and manage information sharing, training sessions or programs related to processes under the responsibility of the Greater Gulf MCO 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 and health-regulated trainings across the country by each GxP & health-regulated Function.

Country Quality Review:

• Support Greater Gulf MCO Quality Head in carrying out an annual Country Quality Review and organizing 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) 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.

Quality of products

2.1. Product complaints

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 of SFDA

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

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 à 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.

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.

• Manage and make decisions regarding temperature excursion during storage or transport

2.4. Quality tasks related to Distribution center and the Distributors:

• Ensure that Good Distribution Practices guidelines are maintained at the distribution center 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.

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 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.

Environmental and Safety Leadership

To care for 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 safety rules and procedures to ensure a safe and healthy working environment.

• Report any accident, incident or near miss, whether it be of personal injury or property damage.

• Assist in the investigation of accidents with the objective of introducing measures to prevent recurrence.

Thoroughly read all safety documentation issued by the Company and comply with its requirements. Escalate any doubts or uncertainties to your supervisor and / or manager.

About you

Experience:

4-6 years of experience in Quality or any Health regulated, Knowledge & experience in Medical, Clinical or in pharmacovigilance domain, Practical GMP/ GDP experience.

Soft skills:

Project Management

Problem solving

Accuracy to details.

Leadership and assertiveness skills

Decision making

Business Partnering

Negotiation and influential skills

Planning and organizing skills

Technical skills:

GMP/ GDP

Quality Management System

Deviation and CAPA management

Distribution knowledge

Audit Readiness

Quality risk analysis/ Quality risk management

  • Education: Bachelor degree in a Pharmaceutical field.
  • Languages: English and Arabic

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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.