Senior Director, GMP and GLP Quality Assurance

Position Description

Job Title: Senior Director, GMP and GLP Quality Assurance
Location: New York, New York preferred; US-remote considered
Reporting to: Vice President, Quality

Position Summary:

IAVI is seeking a Senior Director, GMP & GLP Quality Assurance, who’s a dynamic Quality Assurance Leader, experienced in leading right-sized GMP & GLP organizations, with a focus on QMS phase appropriate design, implementation, who’s eager to make an impact on global public health! The Senior Director will serve as the operational leader for the GMP & GLP quality assurance function, ensuring products, services, and processes meet established quality standards, compliance regulations, and customer expectations. The Sr. Director will implement a robust and scalable quality management system (QMS), driving continuous improvement initiatives across the organization. The Sr. Director leads teams in Quality Systems, Quality Operations, and GMP/GLP Audits and Risk Management.

If you’re a GMP/GLP experienced Quality Assurance Leader, eager to make an impact in a mission-driven organization, apply below!

Key Responsibilities:

• Strategy Development
• Establishing comprehensive GMP/GLP quality assurance strategies, policies, and procedures aligned with IAVI goals, compliance requirements, and industry best practices.
• Defining key quality metrics and performance indicators to monitor and measure quality performance.
• Team Leadership
• Managing and developing a team of quality assurance professionals, with a focus on fostering a strong coaching and development environment.
• Compliance Management and Monitoring
• Analyzing quality data to identify trends, root causes of defects, and implement corrective actions.
• Provide regular communication on GMP/GLP risks and management thereof to Leadership.
• Stay updated on regulatory changes and implementing necessary adjustments to quality processes.
• Cross-Functional Collaboration
• Work closely with other departments (e.g., Human Subject Research QA, Development, Manufacturing, Regulatory Affairs, G&A functions) to integrate quality considerations.
• Continuous Improvement
• Identifying opportunities for process improvement and implementing initiatives to enhance product quality and operational efficiency.
• Fostering a culture of quality within IAVI by promoting continuous learning and feedback mechanisms.

Education and Work Experience:

• Bachelor’s Degree in a Life Sciences or related field is required.
• Minimum of 15+ years of QA experience with a minimum of 7+ years leadership experience in a GMP/GLP organization is required.
• Mid to late-stage drug development experience is required.
• Minimum of 7+ years of managing direct reports is required; Experience leading teams in a global, cross-cultural environment preferred.

Qualifications and Skills:

• Experience in Biologics and/or Vaccines is required.
• Robust presentation skills with ability to distill complex events in concise and approachable manner.
• Clear, direct, and respectful interpersonal, and oral communication skills.
• Ability to influence and inspire others in growth-oriented environment.
• Project Management skills.
• Excellent Working Knowledge of Microsoft Office Applications (e.g. WORD, EXCEL, PowerPoint, Project).

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:

The annual base salary for this position is targeted at$180,000.00 to 220,000.00.

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, three health insurance plans to choose from, and other benefits.