RESPONSIBILITIES:

Ensure CSU alignment and compliance to the sanofi R&D quality system and related clinical operation activities within the Sanofi Group.

Work collaboration: With the respective Country Quality Head (CQH) at country level to ensure, local clinical trial related activities are managed as per the expectations within the Global Quality System and R&D level.

The CSU QL Manager depends on local organization. The CSU QL is a member of the CSU Quality Network

KEY ACCOUNTABILITIES:

1. At global level (global role)

The CSU QL is actively interacting with Global such as:

- Define and update, in collaboration with Clinical Quality and Continuous

- Improvement (CQCI)/Clinical Quality System (CQS), the scientific and technical training curricula for CSU roles (e.g. Mandatory a n d Recommended trainings on QDs, business tools and regulatory topics)

- Lead/Participate as an active member in the preparation/revision of Global QDs that are related to CSU activities

- Lead/Participate to the preparation of Global training programs that are related to CSU activities (e.g. analysis of needs, training proposal review, development and pilot/test)

- Attend corporate meetings and training sessions

- If qualified perform delegated audit related activities within country and or region (supervised by CQCI)

- As applicable participate on In Process Control (IPC) and GCP-PAI Readiness

- Preparation Team, and coordinate with CSU QL network to ensure inspection readiness (IPC)

- Participating in working groups organized by the CSO platform in relation to all his/her duties as applicable

- Identifying and implementing tools to fulfil his/her duties with other company divisions as applicable,

2. At CSU level

The CSU QL is the main contact person for the CSU teams for all quality, process and training aspects. CSU QL should also work closely with the CQH to ensure that CSUrelated activities are appropriately covered in the respective quality systems in all countries part of the CSU.

The CSU QL is also responsible to maintain the appropriate qualification (and thereof documentation) of the CSU staff for:

- Corporate & CSU or country/multi-countries (local) QDs

- Good Clinical Practices (GCP)

- International and local regulations

- Study management activities (e.g. mandatory role-based training)

Therefor at the CSU level, the CSU QL should ensure the following:

General duties:

- Acting as the first point of contact for question on GCP Involvement in the definition of quality indicators for the CSU

- Providing quarterly report on corporate defined quality indicators

-To develop, implement and maintain an integrated quality system to achieve compliance with GCPs and regulatory requirements, as well as operational excellence.

- To lead continuous quality and performance improvement through processes optimization and innovation to positively influence productivity/quality/compliance and deliver to customers values derived from such innovations.

- Support all the CSU initiatives in term of quality

Training:

- Maintenance of appropriate qualification of the CSU staff following recommended training plans

- Contributing to the training of CSU members when new local quality documents are updated or released (training curricula for CSU roles e.g. mandatory and recommended training on QDs, business tools and regulatory topics),

- Tailor functional training based on needs

- Organizing the initial training programs of new comers and the continuing professional knowledge and skills development of CSU members.

- Delivery of GCP training programs

- Deployment/implementation of global training program at CSU level

- Ensure availability of training records at CSU level

- Perform quality visits for site/CRA assessment and improvement, if needed

QD management:

- Reviewing the QD Letters of the Clinical Sciences & Operations (CSO) platform and corporate processes, analyzing or forwarding to the experts for analysis these

documents,

-Distributing QD letter information to the people/entities involved. If necessary, launching the process of revising/updating local quality documents

- Overseeing the follow-up of CSU quality documents and the update of the tracking table. Ensuring the gap analysis versus the global QD list updating or creating local QD if required,

- Ensuring that local CSU quality documents are filed,

- Making quality documents available to CSU team (Geode+/Gibraltar)

- Organizing the update of the local CSU quality documents when required:

- By global procedures

- By local regulation

- When the documents are obsolete (SOP revised every three years and documents updated)

- Oversight on the use of appropriate QDs by Affiliate Medical Affairs for protocol reparation and timely Clinical Study Report completion (Other studies types)

- For Medical affairs: Key provider of applicable quality documents and reference person to be consulted before any new study initiation and together with CQH ensure that local quality documents applicable to the Medical Managers are correctly implemented.

- Escalation to CQCI/CQS of any relevant GCP and/or regulatory information that would require further action

- Maintenance of an historical file of the CSU and/or country/multi country (local) QDs

- Contributing, when requested, to training study sites (making study quality evaluation)

Audit/Inspection duties:

- Preparation and Participation in local audits and GCP inspections

- Involvement in audit performance of CROs working in collaboration with Medical Affaires

- Participation in continuous improvement action/CAPA post audits/post quality reviews and inspections

- Participation in investigations for serious GCP non-compliance/alleged scientific misconduct relevant to their geographic area

Service Provider Qualification duties:

- Based on country organization: Oversight of outsourced partners at local affiliate level that are conducting clinical trial related activities on behalf of CSU and/or Medical Affairs to ensure appropriate vendor qualification is in place.

- Based on country organization: Perform local service provider qualification assessments on GCP activities in cooperation with CQH and Procurement,

- Contributing to the training of local vendors involved in clinical activities (training curricula for CRO, mandatory training on QDs, business tools) and supporting CSU CPL for vendor overseeing,

3.Transversal interactions

Transversal interaction when needed (e.g. quality topic(s), continuous improvement, training, processes, QD and training)

- At affiliate level: With the respective CQHs of the concerned countries, for topics such as affiliate quality systems managed by the CQH, inspections and GCP audits. If applicable, interactions with other affiliate members such as PV, Regulatory, ¡¦

- At CSU level: W ith other stakeholders such as the CSU System Expert, CSU Safety Lead, CTA-RM, CSU Record Specialist and Investigational Product Manager,

- Within the community of CSU QL for collaborative work, sharing experiences and good practices.

- At Global level with stakeholders within CQCI/CQS

- Contributing to topics related to his/her training duties,

QUALIFICATIONS

Education:

Degree in life sciences or scientific discipline or equivalent.

Experience & knowledge:

A minimum of 5 years of professional experience in Clinical Development would be necessary.

Core competencies:

As a requirement for her/his mission, the CSU QL should demonstrate:

- Good working knowledge of global and local clinical development processes.

- Adequate knowledge of GCP and relevant Regulations (country, region and international when applicable)

- Robust transversal communication skills to ensure appropriate business interaction with the various global, CSO, CSU departments and functions, and other partners (e.g. CQH)

- Ability to clearly exchange and train in English (oral & written)

- Conscientiousness, responsiveness, organization and planning

- Negotiation skills

- Autonomy, sense of responsibility and reporting skills