[Closing date: 23 August 2018]
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 (www.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.
Purpose of the position
The Quality Assurance Manager supports the Clinical Quality Management System to ensure compliance of R&D staff with regulatory and company Ethical and Good Clinical Practice requirements, that patient safety and data integrity are respected, that risks are identified, investigated, corrected, and communicated to the QA Leader for escalation to Senior Management if necessary, that the clinical staff, trials, and sites are inspection-ready at all times.
Specific job responsibilities
Quality Documents (QDs)
- Supports the implementation of a practical, user-friendly, compliant system for the management of the DNDi Clinical QDs.
- Supports the overall life-cycle management of Clinical QDs (development or liaison with authors, review, release, roll-out, triggering of update/revision, retirement).
- Supports development of QDs for the Quality Assurance function.
- Reviews all other Clinical QDs for compliance with regulations, company policies, other QDs.
- Ensures availability of current QDs to all DNDi staff on an electronic platform.
- Provides controlled copies to external parties.
- Supports gap analyses of processes.
- Supports process improvement and QD optimization activities.
- Supports company approach for staff training by providing or coordinating training (eg. GCP, QA, Risk Management, QDs).
- Supports maintenance of system to ensure availability of clinical staff training records (CVs, JDs, training logs & records).
Clinical trial support & optimization
- Replaces QA Leader or Senior QA Manager at Extended Disease Team meetings when needed.
- Is an ad hoc member of Trial teams, attends meetings as needed and reviews meeting minutes.
- Acts as GCP expert/consultant and provides expertise, support and/or responds to questions from R&D staff on GCP/QA questions.
- Provides support with interpretation of regulatory guidelines.
- Supports QA Leader input to QA section of Clinical Development Plans, where applicable.
- Identifies potential risks in trial management activities and communicates these to the trial responsible and QA Leader.
Audits and quality control
- Provides input to Audit Plan from discussions/feedback with Trial teams.
- Supports management of out-sourced audit activities, including liaison with auditee and DNDi contact, review of draft audit reports.
- Liaises with auditee for the completion of a Corrective / Preventive Action Plan (CAPA plan) and oversees follow-up and timely close-out of CAPA.
- Feeds information into the tracking tool to be able to provide trends on audits and audit findings.
- Performs quality control reviews of key trial documents (protocols, Informed Consent forms, Clinical Study Reports, Investigator Brochures, and others if requested).
Inspections (or external audits)
- Supports inspection preparation activities and may be called upon to remain with inspector(s) during inspection.
- Provides support to develop and feedback on the inspection CAPA.
- Follows and maintains the system for deviation identification, investigation, root cause analysis, CAPA, tracking, and close-out.
- Supports clinical staff to implement the deviation process.
- Supports Risk Management Plans for clinical activities.
- Supports risk management and risk mitigation activities.
- Interacts with the Pharmacovigilance, Pharmaceutical Development, and Operations functions on quality issues.
- Ensures escalation to QA Leader of major or critical quality issues or risks.
Additional, specific, and projects responsibilities
- Supports organisation of Global Clinical Meeting.
- Provides guidance or quality advice to other DNDi functions (Fundraising, Procurement, Legal).
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/program delivery
- Strong ability to manage medium/large projects with budget management
- Strategic thinking and leadership abilities
- Strong management, negotiation, and advocacy skills
- Has 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)
- Minimum 4-6 years’ relevant experience
- Proven ability to work effectively in a team environment and matrix structure
Advanced post graduate degree or graduate degree with equivalent in experience to reach Master level
- Fluency in English
- Proficiency in local languages desirable
- Very good knowledge of Microsoft Suite
- S/he reports to the Quality Assurance Leader
- Status: full time – permanent role
- Deadline for application: Accepting applications until 23 August 2018
- Only shortlisted candidates will be contacted.