Quality Manager

vor 1 Woche

Geneve, Schweiz Medicines for Malaria Venture (MMV) Vollzeit

Location: Geneva, Switzerland

Full-time

Partially remote

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.

**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.
- Five to eight 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 mínimal supervision when required.

**Start date: 01st May 2024 or at earliest convenience**

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.

Interested applicants should send their CV and a cover letter** by 15th March 2024 **giving reasons for their interest in the position and a short summary of their related experience with regards to above mentioned requirements.

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