Vice President, Quality

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 oversight, 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 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.

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.