Clinical Quality Assurance Manager

**About the Department**:
**The Drugs for Neglected Diseases initiative (DNDi) is an international, not-for-profit research and development (R&D) organization that develops and delivers new treatments for neglected diseases that affect millions of the world’s poorest people.**

Together with more than 200 public research and industry allies worldwide, we use the power of partnership, innovation, open science, and advocacy to find solutions to a great injustice: the lack of medicines for life-threatening diseases that disproportionately impact poor and marginalized people. Driven by collaboration, not competition, and by patients’ needs, not profits, we promote equitable access, foster inclusive and sustainable solutions, and advocate for a more effective global biomedical R&D system that meets the needs of neglected patients.

Since our inception, DNDi has delivered nine new treatments for people with sleeping sickness, visceral leishmaniasis, Chagas disease, paediatric HIV, hepatitis C, and malaria that have saved millions of lives. We now aim to deliver an additional 15-18 new treatments by 2028 - addressing R&D gaps for neglected tropical diseases and viral infections, including new pandemic-prone diseases (such as COVID19) and climate-sensitive diseases (such as Dengue) with a focus on the needs of patients in low
- and middle-income countries.

The R&D organisation include three clusters of Diseases expert teams: NTD/Mycetoma and Leishmaniasis, NTD/Chagas-Filarial-HAT and Viral Diseases. Integrated Clinical Development Sciences (Drug Safety and Pharmacovigilance, Clinical Quality Assurance, Regulatory Sciences and Translational Sciences), Global Clinical Operations, R&D Portfolio and Planning, Discovery and Pharmaceutical Development teams complement the R&D expertise. Projects review, Science and strategy is managed by the Scientific Internal Review Committee (SIRC); The R&D Coordination team lead the R&D organisation for all other topics.

**Overview**:
The Clinical Quality Assurance (CQA) Manager supports the Clinical Quality Management System to ensure:

- Compliance of R&D staff with regulatory and company Ethical and Good Clinical Practice requirements,
- Patient safety and data integrity are respected,
- Risks are identified, investigated, corrected and communicated to the CQA Head for escalation to Senior Management if necessary,
- The clinical staff, trials and sites are inspection-ready at all times.

**Contribution**

This role is accountable for managing smaller scale projects and/or parts of the projects led by upper level, or delivering quality output through expert services or people. This role adapts policies, approaches and models to emerging needs.

**Responsibilities**:
Quality Documents (QDs)
- Develops QDs for the CQA function.
- Reviews all other Clinical QDs for compliance with applicable regulations, company policies, other QDs in particular with regards to regional collaboration and input.
- Supports gap analyses of processes.
- Supports process improvement and QD optimization activities.
- May provide other support to the Global life cycle management of DNDi Clinical QDs, as necessary.

Training
- Supports company approach for staff training by providing training (eg. GCP, QA, Risk Management, CQA QDs).
- Supports Inspection Readiness training to DNDi/Vendor/Site staff.

Clinical Trial Support & Optimisation
- Attends specific disease/project team meetings and reviews meetings minutes as appropriate.
- Is an _ad hoc_ member of Trial teams and reviews meeting minutes as needed.
- Acts as GCP expert/consultant and provides expertise, support and/or responds to questions from R&D staff on GCP/QA questions.
- Is a key CQA contact for and interacts closely with regional R&D staff.
- Interact with the teams for inputs within the Action plan and Audit Plan preparation.
- Provides support, where possible, with interpretation of regulatory GCP guidelines.
- Serves as a reference point for local GCP requirements.
- Input to CQA section of Integrated Product Development Plans (formerly Clinical Development Plans).

Audits / Quality Reviews
- Provides input to Audit Plan from discussions/feedback with Trial Teams.
- Interacts with QA CROs/consultants for out-sourced audit activities, including liaison with the auditees and DNDi contact, review of draft audit reports.
- Liaises with trial responsible (exceptionally auditees) for the compliance of a Corrective / Preventive Action Plan (CAPA plan) and oversees follow-up and timely close-out of the CAPA plan.
- Provides information for the tracking tool to be able to provide trends on audits and audit findings.
- Performs quality reviews of key trial documents (protocols, Informed Consent forms, Clinical Study Reports, Investigator Brochures and others where feasible).

Inspections (or external audits)
- Supports inspection readiness training (in-house or at clinical trial sites).
- Supports inspection preparation activities and may be called