Associate Director, Global Quality Assurance

New TB Vaccines; New York (NY); Remote; USD 140,000 - 155,000; Full time

Job summary

An established industry player is seeking a dedicated Associate Director for Global Quality Assurance. This role involves ensuring compliance in clinical development operations and facilitating quality management systems. The ideal candidate will bring extensive experience in clinical research and quality assurance, with a passion for public health solutions. Join a mission-driven organization that is pioneering vaccine development and making a global impact. This position offers a competitive salary and benefits, along with opportunities for professional growth in a collaborative environment.

Benefits

Annual Bonus

Generous Retirement Savings Plan

Competitive Health Insurance Benefits

Qualifications

• 10+ years of experience in clinical research with 3+ years in Quality Assurance.
• Strong knowledge of vaccine development and industry standards.

Responsibilities

• Support Project Teams in developing quality management plans.
• Prepare teams for regulatory inspections and audits.
• Oversee GCP CAPAs and effectiveness checks.

Skills

GCP Compliance

Quality Management Systems

Clinical Research

Auditing

Regulatory Inspections

Education

Masters Degree in Clinical Research

Post Graduate Qualification in Quality Management

Tools

eTMF Systems

Clinical Trial Systems

Job description

Associate Director, Global Quality Assurance

Job Category: Product Development Center, General

Job Title: Associate Director, Global Quality Assurance
Location: Nairobi, Kenya, Cape Town, South Africa; Remote-South Africa, Remote-Uganda, Remote-Nigeria, New York, New York; US - Remote Considered; United Kingdom – Remote; OR Amsterdam, Netherlands
Reporting to: Senior Director, Clinical Quality Assurance

Position Summary:

Are you a Quality focused leader in clinical development, passionate about bringing forward public health solutions?

IAVI is seeking an experienced and detail oriented Associate Director, Quality Assurance who will ensure compliance of clinical development operations to IAVI and industry standards. The Associate Director will facilitate the Clinical Development group’s participation in the IAVI quality management system where appropriate processes, procedures, and controls are established to ensure clinical research is conducted according to IAVI and industry standards.

Key Responsibilities:

• Support Project Teams with the development of quality management plans relevant to the specific project(s);
• Support and prepare Project Teams for regulatory inspections and external Sponsor audits;
• Serves as the GCP point person for the IAVI electronic QMS, and Clinical Trial Systems, development and implementation;
• Develop and implement QMS compliance assessments for the GCP component of the QMS;
• Develop and implement an eTMF inspection readiness assessment plan for all IND studies;
• Participate in executing the audit plan as delegated;
• Provide training to GCP Operations on best practices and trends as indicated;
• Oversees implementation of GCP CAPAs and conduct the required effectiveness checks;
• Perform other tasks as assigned by the manager.

Education and Work Experience:

• Masters Degree or equivalent in Clinical Research and/or Public Health or related field is required.
• Minimum 10 years of experience in clinical research is required of which at least 3 in Quality Assurance is required.
• Certification as GCP Auditor and/or Post Graduate Qualification in Quality Management is highly preferred.

Qualifications and Skills:

• Strong knowledge and understanding of industry standards and research operations as pertinent to vaccine development is required.
• Experience working with quality management systems is required.
• Experience working with electronic data and records in CFR21Part11 compliant environments is highly desirable.
• Experience as auditor of public health trials is highly desirable.
• Experience working in remote-, virtual-, global-, teams, is highly desirable.
• Ability to travel to research sites throughout the Africa region at up to 30%.

Organizational Overview:

IAVI is a nonprofit scientific research organization dedicated to addressing urgent, unmetglobal healthchallenges including HIV and tuberculosis. Our mission is to translate scientific discoveries into affordable, globally accessiblepublic healthsolutions. Through scientific andclinicalresearch in Africa, India, Europe, and the U.S., IAVI is pioneering the development ofbiomedicalinnovations 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 ofclinicalresearch 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 ourscienceincludes fundamental contributions to understanding thebiologyof HIV infection, whichIAVI and others are applying toward advancing vaccinescienceand 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 addresspublic healththreats that disproportionately affect people living in poverty. Our global reach, including aclinicalresearch 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, andclinicalresearch take advantage ofbio-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 accessiblepublic healthsolutions.
• 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 othermedicalcondition, 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: $140,000.00 - 155,000.00

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, generous retirement savings plan, competitive health insurance benefits, and other benefits.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
This employer is required to notify all applicants of their rights pursuant to federal employment laws.For further information, please review the Know Your Rights notice from the Department of Labor.