As an organization whose mission is to translate science into global public health impact, working on vaccines and therapeutics, IAVI has a vaccine policy which states that subject to applicable law, we require all U.S. and Puerto Rico based employees to be vaccinated for COVID-19, unless they have an approved medical or religious exemption or accommodation. We are committed to supporting our employees during this process as we work to ensure a safe and healthy work environment.
Position Description
Job Title: Vice President, Quality
Location: New York, NY preferred; Remote-US; Cape Town, South Africa; South Africa Remote; Nairobi, Kenya; Amsterdam, Netherlands; OR United Kingdom Remote
Reports to: President & Chief Executive Officer
Position Summary:
Are you an experienced Quality Leader, eager to lead the quality function for a dynamic mission-driven organization?
IAVI is seeking a Vice President, Quality, to lead and drive quality throughout our dynamic and complex organization. The VP of Quality reports to the CEO and leads and manages across all key quality areas. The VP develops and leads IAVI’s quality strategy, goals and objectives, policies, standards, and procedures as they relate to quality and compliance, ensuring strategic alignment with IAVI vision and strategy. The VP oversees and monitors the direction for all quality activities both internally and externally, as well all quality-related improvement initiatives. The VP is accountable for ensuring IAVI has a robust and effective Quality Management System (QMS) in place.
Key Responsibilities:
Organizational Quality Leadership and Culture
- Provide leadership to the development, strengthening and sustaining of a quality culture across IAVI, including the alignment of quality goals and objectives to support IAVI’s strategy and to reflect its values.
- Develop short and long-range organizational quality goals and objectives, policies, consistent with organizational business plans and disseminating the same throughout the quality function.
- Ensure IAVI’s Quality Management System, standards, policies, and processes are fit for purpose, informed by industry best practice, and reviewed for continuous improvement.
- Provide all organizational functions with sound and current quality and compliance direction for all business aspects related to GXPs for internal and external operations.
- Drive functional improvement and transformation of initiatives for quality initiatives throughout the organization, providing technical quality support to improvement and transformation efforts within other functions, being a driver of frequent and consistent of sharing of best practices across the organization.
- Partner within internal functions and project leadership to define target objectives and metrics to ensure proposed systems and processes are feasible, actionable, and aligned with functional standards and project goals.
- Foster a culture of quality within the organization and partners with other members of the LT understand and sponsor IAVI’s quality culture.
Quality Operations
- Oversee the development, implementation, and maintenance of a Quality Management System processes.
- Ensure organizational compliance with current regulatory and company standards of quality.
- Provide oversight, guidance, and ultimate authority for any regulatory health authority inspections that occur for internal operations, including inspection management, response coordination, and driving the organization to completion of relevant corrective actions.
- Partner with external quality functions to ensure clarity in roles and responsibilities, while assuring adherence to GXP compliance and supporting their interaction, alignment or implementation and maintenance of IAVI’s quality standards, processes, and infrastructure.
- Ensure that the QMS includes effective oversight of all external partnerships and outsourced activities.
Leadership of the Quality team
- Provide oversight to all resources working in quality across the organization and builds an understanding of quality responsibilities across the organization.
- Lead and develops the quality team to ensure it continuously evolves to support the needs of the organization.
- Mentor and coach others with specific emphasis on role modeling quality leadership, continuous improvement, and program oversite, metrics, and tracking.
Education and Work Experience:
- BS in chemistry, biological/analytical services, or other related scientific field is required; Advanced degree (MS or PhD) is highly preferred.
- Has completed specific training in quality and is trained and up-to-date on the latest methodologies to implement, lead and continuously evolve and improve quality systems in product development organizations.
- Minimum of 15 years of industrial experience, including 10 years of experience in in quality functions within the pharmaceutical, biotech, vaccine industry is required.
- Broad experience in quality functions, including clinical, regulatory, laboratory, manufacturing is required.
Qualifications and Skills:
- Experience with and knowledge of regulatory health authority laws and regulations is required.
- Vision, self-motivation, as well as exceptional communication and leadership skills.
- Experience leading highly outsourced organizations, with high diversity of partners.
- Experience working in Africa or similar geographies.
- Experience having built robust quality management systems and implementing change management programs to extend quality culture in organizations.
- Extensive experience and depth of knowledge working with QMS within the pharmaceutical, biotech, vaccine research, and clinical development environment is required.
- Ability and experience implementing significant Quality initiatives (e.g. developing new partnerships, remediating a function or external partner’s Quality performance, etc.).
- Ability to collaborate across organizational units ensuring support, engagement, and follow through on strategies & initiatives.
- Experience independently leading significant quality initiatives within a complex global organization.
- Experience effectively managing change and addressing risks in uncertain or ambiguous environments.
- Ability to travel occasionally internationally and domestically.
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: $260,000.00 - 325,000.00
Compensation And Benefits Information for NON-US Based Candidates:
Salary is paid in local currency, and is commensurate and competitive with the local labor market
Please note, there may be some variation based on experience level. In addition, this position offers competitive benefits such as annual bonus, a generous retirement savings plan, three health insurance plans to choose from, and other benefits.
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)