Clinical Quality Assurance Manager (Preference for Malaysia or other South East Asia country. Other locations will be considered).

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.

With 250 employees of 37 nationalities located in nine offices on four continents, DNDi is committed to diversity, equity, and inclusion as essential parts of our culture and key drivers of our success. We encourage candidates of diverse profiles and backgrounds to apply.

The R&D organisation drive therapeutic innovation from the lab bench to the patient bedside. it develops DNDi’s portfolio of drug candidates from the onset (with the design of target product profiles) to the end point (enabling patients’ access to the new treatments). With members located in various DNDi offices worldwide, R&D teams are key enablers of DNDi’s virtual research model which relies on collaborative partnerships with industry and science partners worldwide, fully inclusive of LMICS clinicians and researchers. Projects are run by project leaders and team members regrouping needed expertise from all DNDI functions, beyond R&D.

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.

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.

Experience

• Minimum 6 years' relevant experience working in a clinical trials or GCP environment in which at least 4 years at Senior Officer level
• At least 2 years in quality assurance
• Proven ability to work effectively in a team environment and matrix structure
• Experience of working in public and private sector is highly desirable

Education

• Advanced post graduate degree or graduate degree with equivalent in experience to reach Master level

DNDi Leadership Competencies

DNDi has developed in 2017 a set of leadership competencies and identified behaviors that is referred to as standard for leaders and is aligned to DNDi’s values. The 6 major competency areas are the following:

• Orientation to developing others
• Strategic expertise
• Professional competence
• Care of relationships
• Leading by example

Contextualised skillfulness

• 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)
• Good knowledge of Disease/academia knowledge
• Strong Technical writing skills (procedures, protocols and reports)

• Fluency in English
• Proficiency in local languages desirable
• Good knowledge of Microsoft Suite

DNDi is committed to building a diverse, equitable and truly inclusive organisation. Our success and global reach are dependent upon our ability to encourage diversity and draw on the skills, understanding and experience of all our people. We particularly welcome applications from those who are underrepresented in at DNDi and across the sector, especially women, and including, but not limited to, black and minority ethnic candidates, and those with other protected characteristic.