Drugs for Neglected Diseases initiative (DNDi) is a collaborative, patients’ needs-driven, non-profit drug research and development (R&D) organization that is developing new treatments for Neglected Diseases. (dndi.org)
DNDi has a large portfolio of R&D activities covering 7 disease areas: human African trypanosomiasis, leishmaniasis, Chagas disease, filarial diseases, mycetoma, paediatric HIV, and hepatitis C. R&D projects are driven by patients’ medical needs for each disease area that in turn set strategy and scientific approaches.
DNDi does not have any research facilities and does not directly conduct research to develop its treatments. DNDi follows a virtual research model, whereby most research is outsourced with the R&D projects actively managed by DNDi personnel who are experienced in different aspects of pharmaceutical development. DNDi proactively identifies research opportunities that have the highest potential to be translated into improved treatment options, then sources the research project into its portfolio, builds the full development plan, identifies and contracts the appropriate partners for each step in the development process, and manages the efficient advancement of the project throughout the pipeline.
Over half of the R&D staff are located in Geneva working in close collaboration with disease-specific R&D teams operating in regional offices located in Africa, Asia, and South America.
DNDi Quality Assurance function’s aim is to support the Clinical Quality Management System and to ensure maximum R&D compliance throughout the entire DNDi organization in support of clinical trials conducted to develop treatments for neglected diseases.
Purpose of the position
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 Leader for escalation to Senior Management if necessary
- The clinical staff, trials, and sites are inspection-ready at all times
Specific job responsibilities
Quality documents (QDs)
- Support the implementation of a practical, user-friendly, compliant system for the management of the DNDi Clinical QDs
- Support the overall life-cycle management of Clinical QDs (development or liaison with authors, review, release, roll-out, triggering of update/revision, retirement)
- Support development of QDs for the CQA function
- Review all other Clinical QDs for compliance with regulations, company policies, other QDs
- Ensure availability of current QDs to all DNDi staff on an electronic platform
- Provide controlled copies to external parties
- Support gap analyses of processes
- Support process improvement and QD optimization activities
Training
- Support company approach for staff training by providing or coordinating training (eg. GCP, QA, Risk Management, QDs)
- Support maintenance of system to ensure availability of clinical staff training records (CVs, JDs, training logs & records)
Clinical trial support & optimisation
- Replace CQA Leader or Senior CQA Manager at Extended Disease Team meetings when needed
- Be an ad hoc member of Trial teams, attend meetings as needed, and review meeting minutes
- Attend other meetings as required, in line with need/internal procedures
- Act as GCP expert/consultant and provide expertise, support, and/or respond to questions from R&D staff on GCP/QA questions
- Provide support with interpretation of regulatory guidelines
- Support CQA Leader input to QA section of Clinical Development Plans, where applicable
- Identify potential risks in trial management activities and communicate these to the trial responsible and CQA Leader
Audits/quality control
- Provide input to Audit Plan from discussions/feedback with Trial teams
- Support management of out-sourced audit activities, including liaison with auditee and DNDi contact, review of draft audit reports
- Liaise with auditee for the completion of a Corrective/Preventive Action Plan (CAPA plan) and oversee follow-up and timely close-out of CAPA
- Feed information into the tracking tool to be able to provide trends on audits and audit findings
- Perform quality control reviews of key trial documents (protocols, Informed Consent forms, Clinical Study Reports, Investigator Brochures, and others if requested)
Inspections (or external audits)
- Support inspection preparation activities and may be called upon to remain with inspector(s) during inspection
- Provide support to develop and feedback on the inspection CAPA
- Feed information into the tracking tool for trends on audits and audit findings
Risk management
- Follow and maintain the system for deviation identification, investigation, root cause analysis, CAPA, tracking, and close-out
- Support clinical staff to implement the deviation process
- Support Risk Management Plans for clinical activities
- Support risk management and risk mitigation activities
- Interact with the Pharmacovigilance, Pharmaceutical Development, and Operations functions on quality issues
- Ensure escalation to CQA Leader of major or critical quality issues or risks
- Participate in regular CQA meetings to discuss QA/GCP issues and align/harmonize approach
Additional/specific/projects responsibilities
- Support organization of Global Clinical Meeting
- Participate to and provide information and support for Annual Clinical Quality Review Meeting
- Provide GCP guidance or quality advice to other DNDi functions (Fundraising, Procurement, Legal)
Reporting line
- S/he reports to the Clinical Quality Assurance Leader based in Geneva
Job requirements
Skills and attributes
- Strong ability to use initiative, prioritize, multi-task, and work well under pressure to meet deadlines
- Clear and systematic thinking that demonstrates good judgment and problem-solving competencies
- Strong communication skills in multicultural, multi-lingual environments
- Strong ability to work effectively as part of a multicultural team
- Well organized and structured
- Strong analytical skills
- Strong ability to provide high level support in project/programme delivery
- Strong ability to manage medium/large projects with budget management
- Strategic thinking and leadership abilities
- Strong management, negotiation, and advocacy skills
- Have autonomy for taking actions and decisions
- Strong ability to interact with external stakeholders
- Lead and motivate a small team for optimum performance, supervising junior staff
R&D technical skills
- Good knowledge of drug discovery/development
- Very strong knowledge of clinical research/development
- Very strong knowledge of ethical principles, pertinent regulatory requirements and Good Clinical Practice (GCP), and company policies and procedures
- Good knowledge of Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP)
- Strong technical writing skills (procedures, protocols, and reports)
Experience
- Minimum 6 years' relevant experience in which at least 4 years at Senior Officer level
- Proven ability to work effectively in a team environment and matrix structure
Education
- Advanced post graduate degree or graduate degree with equivalent in experience to reach Master level
Other requirements
- Fluency in English
- Proficiency in local languages desirable
- Very good knowledge of Microsoft Suite
Other information
- Status: Full time
- Some travel will be required
To apply
- Deadline for application: Accepting applications until 28 August 2020
- Only shortlisted candidates will be contacted
- Application submission for this position may close early if we have enough suitable applicants
