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
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