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 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.

· Transparent 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.

Pay: ₹1,300,000.00 - ₹2,200,000.00 per year

Application Question(s):

- Have you worked in a biobank/biorepository? What specimens and approximately what responsibilities did you personally handle?
- Have you implemented or worked against ISO 20387:2018? If not, which accredited QMS standard have you worked under and in what capacity?
- Describe your direct involvement in document control, internal audits, non-conformities, CAPA and accreditation/readiness assessments.
- Which LIMS/BIMS/sample inventory system have you used, and how did you maintain sample identity, location and traceability?

Education:

- Master's (Preferred)

Experience:

- biobank operations, clinical laboratory quality systems: 3 years (Required)

Work Location: In person

📌 Consultant – Biobanking Quality and Operations (Gurugram)
🏢 IAVI
📍 Gurugram