Medicines for Malaria Venture (MMV) is a leading product development partnership (PDP) in the field of antimalarial drug research and development. Its mission is to reduce the burden of malaria in disease-endemic countries by discovering, developing and delivering new, effective and affordable antimalarial drugs.
Over the past two decades, MMV has worked with an extensive network of donors, private and public sector partners, experts and clinical centers in endemic countries to develop an outstanding portfolio of antimalarial projects.
The successful candidate will play a pivotal role in ensuring that all MMV activities align with MMV Quality policies through the implementation of Standard Operating Procedures (SOPs) in accordance with GCP requirements. This position involves overseeing the organization's Quality Management System (QMS), conducting internal quality/process audits, assessing the adherence to standards and regulations by MMV and external partners in the context of clinical trial/studies conduct and maintaining a culture of adherence to quality standards. The position reports into the Associate Director, Quality.
Primary duties and responsibilities:
- Administer and maintain QMS documents, including organizing, reviewing, updating, and initiating the writing of internal SOPs, policies and associated documents.
- Lead, monitor and evaluate quality control processes around clinical trials/studies to ensure adherence to standards and regulations.
- Make independent decisions and assessments on Quality-related matters as delegated by the Associate Director.
- Monitor the reporting and conduct follow-up of incidents related to MMV projects in collaboration with project directors and external partners.
- Overseeing and managing activities of the archiving function with external partner(s), including archiving processes of RD activities, documentation, managing Trial Master Files, ensuring compliance with regulatory standards, efficient retrieval of documentation, ensuring quality end to end TMF process, database maintenance, document Retention Plans, physical archives
- Work closely with cross-functional teams and manage QA aspects of projects to identify areas for process improvement and implement corrective actions for continuous processes improvement.
- Analyze quality data and generate reports for management review.
- Develop and deliver quality training programs to enhance staff understanding and adherence to quality standards and regulations.
- Organize (document, plan, monitor) internal quality and process audits, from preparation to responding to findings identifying root causes, and implementing improvements.
- Organize and conduct gap analyses of current quality projects
- Work independently on specific QA projects, including all clinical trials/studies, under general supervision.
- Promote quality standards among staff members and partners to ensure their consistent and successful implementation
Education and Work Experience
- University degree in natural sciences or pharmacy.
- Eight to ten years of experience in a multinational environment, including a minimum of 3 years within a pharmaceutical company.
- Previous roles in quality auditing and document management within a clinical department are essential.
- Experience in writing and/or reviewing Standard Operating Procedures (SOPs).
- Strong knowledge of Good Clinical Practice (GCP) and regulatory requirements in the pharmaceutical field.
- Awareness of principles of Good Manufacturing Practice (GMP) and Good Laboratory Practice (GLP).
- Experience in project management is a plus.
Technical Skills
- Fluency in English (oral and written); good command of French.
- Experience with computer systems such as Sharepoint, Microsoft Office, ERP systems, and project management software.
Behavioural Skills
- Strong organizational and time management skills, used to prioritizing.
- Analytical and research skills, attention to detail.
- Project management, planning, and analytical skills.
- Conflict resolution skills.
- Strong team player with excellent interpersonal skills and ability to interact with colleagues and partners with integrity and diplomacy
- Capacity to communicate clearly and effectively both in writing and verbally.
- Ability to manage relationships and influence others with respect.
- Able to work independently and with minimal supervision when required.
Start date: January or February 2025
Location: Geneva, Switzerland
At MMV, we consider individuals for employment based on their skills, abilities, and experience. We strive to attract and hire a strong, talented, and diverse workforce, prohibiting discrimination based on race, colour, religious or political beliefs, age, nationality, physical, mental, or developmental disability, gender, sexual orientation.
We are working in a hybrid workplace environment and would expect the selected candidate to be at the office two to three days per week. This is not a remote hire and MMV offers relocation assistance for suitable qualified candidates coming from abroad.
Interested applicants should send their CV and a cover letter by 15 November 2024 giving reasons for their interest in the position and a short summary of their related experience with regards to above mentioned requirements.
Recruitment agencies are kindly requested to refrain from submitting applications.
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Last updated on Oct 28, 2024