Document Manager, Quality Assurance

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: Document Manager, Quality Assurance
Location: New York, NY, USA or US - Remote
Reports to: Associate Director, Quality Systems
Position Summary:
Are you a detailed oriented Document Manager with experience in drug development?
IAVI is seeking a Document Manager, Quality Assurance to lead quality efforts for documentation across the organization.
The Document Manager, QA will lead the management of controlled documents and records for the Quality Assurance unit, guiding and supporting all functional units on IAVI's document management policies and procedures. The Document Manager implements strategies to mitigates risks, as well as reviews deviations, develops and participates in CAPAs, and leads change management. The Document Manager is an SME, providing user training and administrative support for IAVI's electronic document, quality, and learning management systems.
Key Responsibilities:

• Creates, maintains, distributes and archives documents and records for the QA unit.
• Supports development of and adherence to QA document management plans.
• Supports organizational document management risk mitigation strategy.
• Acts as document change manager for QA owned policies and procedures, including facilitation of periodic review and completion of impact assessments.
• Provides guidance to functional units including but not limited to CMC, regulatory affairs, clinical development, and IT to ensure adherence to IAVI policies and procedures, Good Documentation Practices (GDocP), ALCOA+, and data integrity principles.
• Provides input on the development and revision of Quality policies and procedures, and functional unit procedures specific to document and records management.
• Provides basic training and user support for the electronic document management system (Veeva QualityDocs) and learning management system (ComplianceWire).
• Develops training materials and requirements for quality systems and document management processes.
• Administration of training plans through ComplianceWire Learning Management System.
• Participates in the documentation and management of QA-owned quality events including deviations, CAPAs, and change controls.
• Supports the continuous improvement of the Quality Management System.
• Creates and distributes reports and dashboards to track quality metrics and KPIs.
• Delivers QA unit updates during quarterly Quality Management Council meetings.
• Assists in the planning and execution of the annual Quality Summit.
• Performs other tasks as assigned by the manager.

Education and Work Experience:

• Bachelor's Degree in the life sciences, or related technical field is required.
• Minimum of 5 years of industry experience is required.
• Minimum of 2 years' experience performing a QA documentation and records management role within the R&D, biotech, or pharmaceutical industry is required.

Qualifications and Skills

• Experience working with Good Documentation Practices, ALCOA+, and data integrity principles are required.
• Experience in the use of an electronic document management system is required.
• Experience in the creation of training materials, process flow diagrams (e.g. Lucidchart) and presentations is preferred.
• Familiarity with 21 CFR Part 11, the GxP's including GLP, cGMP, GCLP, and GCP, and computerized system validation is preferred.
• Experience in the use and administration of Veeva QualityDocs and UL ComplianceWire is preferred.
• Ability to project a supportive, empathetic and patient approach to effectively coach and support system end users across multiple units in a global virtual work environment is preferred.

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: $85,000.00 - 100,000.00
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.
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)