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 technicaltraining curricula for CSU roles (e.g. Mandatory a n d Recommended trainings onQDs, business tools and regulatory topics)

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

- Lead/Participate to the preparation of Global training programs that are related to CSUactivities (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 inspectionreadiness (IPC)

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

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

2. At CSU level

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

The CSU QL is also responsible to maintain the appropriate qualification (and thereofdocumentation) 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 definitionof quality indicators for the CSU

- Providing quarterly report on corporate defined quality indicators

-To develop, implement and maintain an integrated quality system to achievecompliance with GCPs and regulatory requirements, as well as operationalexcellence.

- To lead continuous quality and performance improvement through processesoptimization and innovation to positively influence productivity/quality/compliance anddeliver 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 recommendedtraining plans

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

- Tailor functional training based on needs

- Organizing the initial training programs of new comers and the continuing professionalknowledge 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 andcorporate 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 trackingtable. Ensuring the gap analysis versus the global QD list; updating or creating localQD 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 anddocuments updated)

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

- For Medical affairs: Key provider of applicable quality documents and referenceperson to be consulted before any new study initiation and together with CQH ensurethat local quality documents applicable to the Medical Managers are correctlyimplemented.

- Escalation to CQCI/CQS of any relevant GCP and/or regulatory information thatwould 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 collaborationwith Medical Affaires

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

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

Service Provider Qualification duties:

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

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

- Contributing to the training of local vendors involved in clinical activities (trainingcurricula for CRO, mandatory training on QDs, business tools) and supporting CSUCPL 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 suchas affiliate quality systems managed by the CQH, inspections and GCP audits. Ifapplicable, interactions with other affiliate members such as PV, Regulatory, …

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

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

- At Global level with stakeholders within CQCI/CQS