Senior Manager, Quality Systems

Position Description  

Job Title:             Senior Manager, Quality Systems
Location:            New York, NY, US-Remote, Nairobi, Kenya, Cape Town, South Africa, Remote-South Africa, Amsterdam, Netherlands, Remote-United Kingdom
Reporting to:     Director, Quality Assurance

Position Summary:

Are you an experienced drug development Quality Systems leader who’s looking for an opportunity to make an impact on global public health? 

IAVI is seeking a Sr. Manager, Quality Systems who is critical in the development, maintenance, and continuous improvement of IAVI’s Quality Management Systems (QMS). In this key position, the Senior Manager ensures the strategic design, development, implementation, maintenance, and enhancement of a robust QMS to support GxP compliance.

Join IAVI and apply your QA Systems expertise to a critical mission in public health!

Key Responsibilities:

Quality Systems and Quality Assurance Activities

• Collaborates with the Director, Quality Systems to develop, implement, and monitor the effectiveness of all core Quality Systems in compliance with applicable regulations and industry standards (e.g. Deviation Management, CAPA, Change Control, Documentation, Training).
• Provides direction and support to the organization on quality system related matters.
• Manages the resolution of complex compliance and/or quality systems issues as they arise.
• Leads the strategic approach to advance the GxP training program, including leading the development and delivery of training initiatives.
• Serves as a Subject Matter Expert (SME) to provide user training and administrative support for IAVI’s electronic document, quality, and learning management systems.
• Manages the use and continuous Improvement of the electronic Quality Management System, eQMS, working with the Document Manager to oversee document lifecycle management.
• Drives a culture of quality throughout IAVI and promotes a growth mindset among team members.
• Support the development of the Quality Department budget in alignment with routine planning cycles.
• Performs other duties as assigned by the Director.

Education and Work Experience:

• Bachelor’s Degree in the life sciences or technical field is required.
• Minimum of 6 years of experience in QMS roles within GxP environment is required.
• Minimum of 2 years management experience with direct reports required.

Qualifications and Skills:

• Previous experience in quality management system gap assessment, design, build, and deployment as the primary QA owner
• Previous QA experience within GxP late-stage development environments
• Demonstrates strong knowledge of GxP regulations, Good Documentation Practices, ALCOA+, and data integrity principles are required.
• Experience with electronic document management systems is required.
• Experience leading and managing quality projects is required.
• Working Knowledge of Microsoft Word, EXCEL, PowerPoint is required.
• Experience designing and implementing phase appropriate, right-sized QMS is required.
• Experience in the creation of training materials, process flow diagrams (e.g. Lucidchart) and presentations is required.
• Experience with late stage (Phases 2b-3) clinical development highly preferred.
• Experience with the use and administration of Veeva QualityDocs and UL ComplianceWire is preferred.
• Exhibits a supportive, empathetic and patient approach to effectively coach and support system end users across multiple units in a global virtual work environment.
• Possesses strong analytical and problem-solving skills.
• Ability to manage multiple priorities with minimal supervision.

Organizational Overview: 

IAVI is a nonprofit scientific research organization dedicated to addressing urgent, unmet global health challenges including HIV and tuberculosis. Our mission is to translate scientific discoveries into affordable, globally accessible public health solutions. Through scientific and clinical research in Africa, India, Europe, and the U.S., IAVI is pioneering the development of biomedical innovations designed for broad global access. We develop vaccines and antibodies in and for the developing world and seek to accelerate their introduction in low-income countries. IAVI programs and partnerships are grounded in the regions of the world where the disease burden is the greatest, and our approach emphasizes sustainability. Our network of clinical research center partners in Africa and India helps strengthen in-country research capacity and supports the training and education of the next generation of scientists. The global impact of our science includes fundamental contributions to understanding the biology of HIV infection, which IAVI and others are applying toward advancing vaccine science and immunology. IAVI accelerates scientific discovery and development by fostering unique collaborations among academia, industry, local communities, governments, and funders to explore new and better ways to address public health threats that disproportionately affect people living in poverty. Our global reach, including a clinical research network in five countries in sub-Saharan Africa and in India, has allowed us to make fundamental contributions to understanding the epidemiology, transmission, virology, and immunology of HIV. This work played a key role in facilitating the design of promising HIV vaccine candidates, as well as the discovery of broadly neutralizing antibodies that are now being advanced as promising approaches for HIV prevention. Our integrated capabilities in vaccine and antibody discovery, development, and clinical research take advantage of bio-pharmaceutical industry expertise to accelerate the development and testing of prevention methods for HIV and other diseases. Through the Product Development Center, we support external researchers with technical and scientific expertise to accelerate the development of their own products.  

IAVI CORE VALUES: 

• Dedication to the Mission: We are committed to the translation of scientific discoveries into affordable, globally accessible public health solutions. 
• Innovative Evolution: We are committed to solving complex problems in creative and innovative ways, learning from our mistakes and successes and never giving up 
• Integrity: We are committed to meeting the highest ethical and professional standards in everything we do and to taking responsibility for our actions to earn respect 
• Collaboration: We are committed to embracing diversity, the power of global teamwork and the belief that by working as one we can make a difference

Disclaimer: Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time. The above statements are intended to describe the general nature and level of work being performed by individuals assigned to this position. They are not intended to be an exhaustive list of all duties, responsibilities and skills required of personnel so classified. This document does not create an employment contract, implied or otherwise, other than an “at-will” relationship. IAVI is an equal opportunity employer and applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.  

IAVI IS AN EQUAL OPPORTUNITY EMPLOYER actively committed to fostering a diverse and inclusive global organization. IAVI believes that diversity and inclusion among our teammates is critical, and we seek to recruit, develop and retain the most talented people from a representative candidate pool. At IAVI, we celebrate the spectrum of colleagues’ experiences and believe that dedication to our mission above all is essential to our success as a scientific global non-profit. IAVI upholds these principles through IAVI’s Global Diversity and Inclusion Committee.  

IAVI has zero tolerance for discrimination or harassment on the basis of race, color, ethnicity, caste, national origin, home language, ancestry, religion, marital or civil partnership status, age, physical or mental disability, HIV status and any other medical condition, genetic information, pregnancy, sexual orientation, gender identity or expression, and veteran status, in addition to any other status protected under the law in any of our locations worldwide. 

Compensation and Benefits Information for US-Based Candidates:   

Annual base salary for this position is: $120,000.00 - 135,000.00 

Please note, there may be some variation based on experience level. In addition, this position offers competitive benefits such as annual bonus, generous retirement savings plan, competitive health insurance benefits, and other benefits.