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Glp Quality Assurance Manager

Company

IAVI

Address , New York, 10004, Ny
Employment type FULL_TIME
Salary
Expires 2023-07-02
Posted at 1 year ago
Job Description

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: GLP Quality Assurance Manager
Location: New York, NY or Remote, US
Reporting to: Director, QA Audit Lifecycle Management

Position Summary:

IAVI is seeking an experienced GLP Quality Assurance Manager who is eager to help translate science, into global health impact! The GLP QA Manager candidate will have a thorough understanding of GLP compliance, and lead the development, maintenance, and continuous improvement of IAVI’s GLP Quality Assurance Program. This experienced GLP Quality Assurance expert provides guidance and support, ensuring GLP compliance in an effective and efficient way.

Key Responsibilities:

Operational Activities

  • Assist in the development, approval, and maintenance, and management of agreements (e.g. confidential disclosure agreements, RFPs, Consulting Agreements, MSAs, quality agreements, etc).
  • Mentor and provide guidance to junior QA colleagues across IAVI.
  • Review agreements (e.g. MSAs with CROs,) for GLP Quality Assurance inputs required for the execution of agreements.

GLP Quality Assurance Activities

  • Provide recommendations and guidance on GLP requirements to Internal Project teams.
  • Conduct inspections and audits of studies or portions of studies conducted by IAVI.
  • Work with departmental management and program/project team directors to establish work plans (including GANTT Charts) related to GLP Quality Assurance activities.
  • Compile documentation in preparation for the audit.
  • Review and assess corrective action plans and follow-up on the resolution of audit findings.
  • Development of GLP Quality Assurance related SOPs.
  • Inspect and audit nonclinical laboratory safety studies to assure quality and compliance with Good Laboratory Practice (GLP) and other applicable regulations and departmental procedure.
  • Coordinate the use of continuous improvement of the electronic quality management system (eQMS).
  • Review audited final reports and raw data from external vendors (e.g., contract research organizations).
  • Prepare clearly written, accurate, and evidence-based audit reports to effectively communicate the audit findings to the auditees and management.
  • Review study protocols, amendments, and deviations.
  • Perform GLP systems audits at contract research organizations, for the purpose of assessing regulatory compliance.
  • Review method development, method validation, and safety study data.

Education and Work Experience:

  • Bachelor’s Degree in a life sciences or related field; advanced degree desirable;
  • 5 years of experience in GLP Quality Assurance or related role or function.

Qualifications and Skills:

  • Strong working knowledge and experience with of Microsoft Office Applications (Word, Excel, Powerpoint, Project) highly desirable.
  • RQAP-GLP credentials preferred.
  • Experience managing and conducting GLP audits required.
  • Experience with Animal Rule studies desirable
  • Experience with data integrity required.
  • Ability to travel up to 30% required.
  • Experience in biologics and / or vaccines is highly desirable
  • Excellent interpersonal skills, including written and oral communication skills are highly desirable.

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:

  • 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
  • Innovative Evolution: We are committed to solving complex problems in creative and innovative ways, learning from our mistakes and successes and never giving up
  • Dedication to the Mission: We are committed to the translation of scientific discoveries into affordable, globally accessible public health solutions.
  • 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

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 $85,000-95,000 with 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)