Clinical Quality Assurance Manager at Drugs for Neglected Diseases initiative (DNDi)

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