Biobanking Quality and Operations, IAVI India

India; Gurugram District; On-site; INR 900,000 - 1,300,000; Full time

Job summary

IAVI India seeks a Consultant – Biobanking Quality and Operations in Gurugram, Haryana to strengthen a government-led biobank network. You will translate ISO 20387:2018 requirements into practical, site-level systems and provide hands-on operational support for quality management, documentation, and monitoring across participating sites.

The role involves developing SOPs, conducting readiness assessments, coordinating training, and supporting accreditation activities while collaborating with

Qualifications

• Post-graduate degree in biological sciences with 3+ years of relevant experience in biobank operations or related field.
• Demonstrated experience supporting ISO 20387 or comparable quality-system requirements is preferred.
• Experience implementing SOPs, document control, audits/readiness assessments, and biospecimen lifecycle management is required.

Responsibilities

• Support implementation of the biobank roadmap and site-workplans.
• Design and maintain quality management systems aligned with ISO 20387:2018.
• Develop SOPs, forms, registers, and related documents for biobank management.
• Conduct site-readiness and gap assessments across infrastructure, equipment, staffing, biosafety, and data protection.
• Provide day-to-day operational support including tracking milestones and risk escalation.
• Coordinate training for biobank personnel on SOPs and quality systems.
• Assist with ISO 20387 accreditation preparation and corrective actions.
• Support Biobank Information Management System deployment and data quality checks.
• Contribute to sample and data sharing guidelines and donor reporting.

Skills

ISO 20387 knowledge

Biospecimen lifecycle

SOP development

Quality systems

Documentation

Training coordination

BIMS familiarity

Data protection

Education

Post-graduate degree in biological sciences

3+ years biobank ops experience

Tools

MS Word

PowerPoint

Excel

Job description

Biobanking Quality and Operations, IAVI India

Job Category: India Regional Programs

Requisition Number: BIOBA001422

Contract: Full-Time

Locations

Showing 1 location

Description

Job Title: Consultant – Biobanking Quality and Operations, IAVI India Location: Gurugram, Haryana Reports to: Associate Director, Clinical Operations and Epidemiology

Help strengthen biobanking capacity and advance diagnostic research in India. IAVI is seeking a Consultant – Biobanking Quality and Operations to support a Government of India-led initiative strengthening a network of biobanks aligned with international quality standards. Bring your biobanking experience to help translate ISO requirements into practical, site-level systems.
IAVI is a non-profit scientific research organization dedicated to developing vaccines and antibodies for HIV, tuberculosis, and emerging infectious diseases. In India, IAVI has been a longstanding partner to the Government of India, providing technical assistance, capacity strengthening, knowledge, and project management support for diverse national initiatives.
IAVI is supporting a Government of India-led initiative to establish and strengthen a network of biobanks at identified laboratories in accordance with ISO standards. The initiative aims to advance in-vitro diagnostic research and development in India through standardized biospecimen management practices aligned with international best practices. The Consultant – Biobanking Quality and Operations will work under the guidance of the project’s senior scientific and technical leads to provide hands‑on operational support for quality management systems, harmonized procedures, site‑readiness activities, training, documentation, and monitoring in alignment with ISO 20387:2018 and applicable national requirements. The role is suited to an early- to mid‑career professional with prior experience in supporting or managing an ISO‑aligned biorepository and the ability to translate quality requirements into practical site‑level systems.

Key Responsibilities

• Support implementation of the biobank roadmap and site‑specific workplans for the identified laboratories, working closely with the scientific lead, experts, government stakeholders and participating sites.
• Support design, implementation, and maintenance of quality management systems aligned with ISO 20387:2018, including document control, records management, internal checks, non‑conformity management, corrective and preventive actions, risk management, and continual improvement.
• Develop, adapt, and facilitate implementation of SOPs, forms, registers, and related controlled documents for biobank management.
• Conduct or support site‑readiness and gap assessments covering infrastructure, equipment, workflows, staffing, biosafety, ethics, data protection, traceability, and quality requirements; document findings and follow through on agreed actions.
• Provide day‑to‑day operational support to participating sites as they establish or strengthen biobanks, including review of implementation evidence, maintenance of trackers, monitoring of milestones, and escalation of risks or delays.
• Support preparation for ISO 20387 accreditation at selected biobanks, including documentation review, readiness checks, gap closure, and coordination of corrective actions arising from assessments.
• Coordinate training for biobank personnel on SOPs, quality systems, biospecimen lifecycle management, equipment and inventory controls, and related operational requirements.
• Support implementation and use of a Biobank Information Management System including user requirements, sample traceability, data‑quality checks, and user support.
• Contribute to sample and data sharing guidelines, workshops, stakeholder meetings, technical reports, progress updates, and donor reporting.
• Engage professionally with government and institutional stakeholders, communicate progress and risks proactively, and undertake related responsibilities assigned by the supervisor.

Education and Work Experience

• Post‑graduate degree in biological sciences with 3+ years of relevant experience in biobank operations, clinical laboratory quality systems, or a related setting.
• Demonstrated experience supporting or managing a biobank in accordance with ISO 20387 or comparable accredited quality‑system requirements is strongly preferred.
• Practical experience with SOP implementation, document control, audits or readiness assessments, staff training, and biospecimen lifecycle management is required.

Qualifications and Skills

• Working knowledge of ISO 20387:2018 and its application to biobank governance, personnel competence, facilities, equipment, process control, traceability, quality assurance, and continual improvement.
• Understanding of biosafety, ethics, privacy, and data‑protection considerations relevant to human biospecimens.
• Ability to interpret quality requirements, identify operational gaps, develop practical corrective actions, and maintain accurate, inspection‑ready documentation.
• Familiarity with BIMS or electronic inventory systems, sample tracking, and data‑quality controls.
• Strong organization, attention to detail, problem‑solving, and follow‑through, with the ability to manage multiple site‑level activities and work effectively with appropriate guidance.
• Clear written and verbal communication skills and the ability to collaborate constructively with scientific experts, laboratory teams, government stakeholders, and project colleagues.
• Proficiency in Microsoft Word, PowerPoint, and Excel, including trackers, structured datasets, reports, and presentations; willingness to travel within India for site assessments, training, and monitoring visits.

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

• Commitment: We deliver on our mission, proactively transforming promises into tangible results
• Stewardship: We steward IAVI's resources responsibly to ensure IAVI's long‑term success and global health impact
• Integrity: We uphold strong moral principles to maintain our credibility as a nonprofit scientific research organization
• Collaboration: We work as one IAVI team and partner with others to deliver globally accessible, urgently needed, public health solutions

Disclaimer

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

IAVI is an equal opportunity employer. It is IAVI’s policy to provide equal opportunity without regard to race, citizenship, color, sex, gender identity or expression, age, height, weight, disability (including physical and mental conditions unrelated to job performance), religion, creed, caste, home language, ancestry, national origin, pregnancy, marital or partnership status, sexual orientation, status as a protected veteran, ethnicity, genetic information, predisposing genetic characteristic, status as a victim of domestic violence, stalking and sex offenses, HIV status, or any other status protected by applicable federal, state, or local laws.