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Associate Director, Global GCP Quality
IAVI New York, NY
$167k-208k (estimate)
Full Time | Durable Manufacturing 2 Months Ago
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IAVI is Hiring a Remote Associate Director, Global GCP 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: Associate Director, Global GCP Quality
Location: Cape Town, South Africa; Remote-South Africa; Nairobi Kenya, New York, NY, US-Remote, or Remote – United Kingdom
Reporting to: Senior Director, Clinical Quality Assurance

Position Summary:

Are you a GCP Quality leader eager to make an impact in a mission-driven organization?

IAVI is seeking an Associate Director, Global GCP Quality to partner with the Sr. Director, Clinical QA, ensuring clinical development operations compliance, and adherence to IAVI and industry standards. The Associate Director will facilitate the development and implementation of the GCP audit plan, helping to drive success of the global QA audit plan, ensuring appropriate processes, procedures, and controls are in place.

Help translate science into global health solutions as an Associate Director, Global GCP Quality at IAVI!

Key Responsibilities:

  • Initiate the development and oversee the implementation and maintenance of the annual Clinical Development GCP audit plan.
  • Serve as key liaison for Clinical Development for audit requests.
  • Coordinate, facilitate and administer meetings required in support of the GCP annual audit plan.
  • Confirm budget availability and allocation for audits requested with the QA Budget representative.
  • Identify Auditor availability and submit resource assignment proposal for director’s approval:
    • Support the identification and qualification of new consultants.
    • Maintain a consultant’s records database.
    • Oversee consultants training on IAVI SOPS.
  • Liaise with IAVI contracts and finance to get the required contracts and financial agreements in place prior to audit initiation.
  • Manage and oversee the audit management process according to relevant SOPs, including:
    • Contacting the auditee in planning phases for planning information.
    • Coordinating internal planning meetings.
    • Serve as primary liaison with the Auditor assigned to the audit.
    • Coordinating audit workflow according to agreed timelines and schedule.
    • Oversee quality of audit process documentation by approving all audit life cycle documents in the QMS.
    • Participate in meetings relevant to this process as indicated.
  • Compile GCP audit plan metrics on quality and progress on a quarterly basis.
  • Prepare vendor client satisfaction surveys for approval by the Director.
  • Develop and improve current procedures and tools to support the GCP audit process.
  • Participate in executing the audit plan as delegated.
  • Perform other tasks as assigned by the manager.

Education and Work Experience:

  • Bachelor’s degree in life sciences or related field is required; Advanced degree is highly preferred.
  • Minimum 8 years of experience in clinical research is required.
  • Minimum of 4 years’ experience in quality assurance is required.
  • Experience working with project budgets, contracts, Quality Management Systems (Veeva QMS), and Project Management System (Smartsheets) is required.
  • Experience with auditing and/or quality oversight is required.

Qualifications and Skills:

  • Experience working with industry standards and research operations related to vaccine development.
  • An exceptional knowledge and understanding of electronic quality management systems, with specific reference to the audit process, is desirable.
  • 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.

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: $135,000.00 - 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, 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)

Job Summary

JOB TYPE

Full Time

INDUSTRY

Durable Manufacturing

SALARY

$167k-208k (estimate)

POST DATE

04/25/2024

EXPIRATION DATE

07/21/2024

WEBSITE

iavi.org

HEADQUARTERS

MANHATTAN, NY

SIZE

200 - 500

FOUNDED

1996

CEO

MARGARET MCGLYNN

REVENUE

$50M - $200M

INDUSTRY

Durable Manufacturing

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