Head of Quality Assurance

Job Description: Head of Quality Assurance Operations Company: Jeevatva Biosciences Private Limited Location: IIT Kanpur, Kanpur, Uttar Pradesh, India Position Type: Full-Time Posted: July 1, 2026 Company Overview Jeevatva Biosciences is a pioneering biotechnology company dedicated to developing novel Live Biotherapeutic Products (LBPs) to address significant unmet medical needs in India. Our lead candidate, JB001, is a rationally designed, multi-strain consortium of commensal microbes aimed at treating human diseases by restoring microbial balance. We are a science-driven team committed to translating cutting-edge microbiome research into safe and effective therapies. As we scale up our operations, we are establishing a state-of-the-art, Schedule M-compliant manufacturing facility to support our clinical pipeline. Position Summary We are seeking a highly experienced and visionary Head of Quality Assurance (QA) Operations to establish, scale, and oversee our entire quality management landscape in a dynamic startup environment. This is a pivotal leadership role responsible for ensuring strict GxP compliance across all stages of development—from preclinical research to clinical manufacturing. The ideal candidate will act as the ultimate guardian of data integrity and traceability. You will supervise a team of scientists and technicians, manage external compliance with Contract Research Organizations (CROs) for toxicology studies, and serve as the core quality stakeholder collaborating with engineering partners to build, commission, and validate our new Schedule M-compliant Live Biotherapeutic manufacturing plant. The candidate must possess comprehensive overall knowledge of facilities, with specific expertise in closed fermentation, single-use systems, cleanroom engineering, regulatory audits, IBSC compliance, and corporate certifications like DSIR. Key Responsibilities Facility Setup, Cleanrooms & Engineering Validation: Schedule M & Cleanroom Alignment: Provide strategic QA leadership for the design, construction, commissioning, and qualification of a new, small-scale Schedule M-compliant manufacturing plant, specifically managing cleanroom facility environmental classifications and monitoring protocols. Closed & Single-Use Systems: Establish quality risk assessments and validation frameworks for closed fermentation processes and single-use technologies (SUT) to ensure sterility and minimize cross-contamination risks. Equipment & Process Validation: Oversee and approve Equipment Qualification (DQ, IQ, OQ, PQ), clean utility validation (HVAC, purified water, gases), and tech transfer from Process Development to manufacturing. Regulatory Audits, IBSC & Corporate Certifications: Audit Leadership: Lead, manage, and host regulatory, vendor, and third-party inspections/audits. Establish robust internal audit programs to ensure continuous compliance. IBSC Compliance & Biosafety: Serve as a key liaison or member of the Institutional Biosafety Committee (IBSC) , ensuring all research, preclinical manufacturing, and microbial strain handling conform to DBT (Department of Biotechnology) biosafety guidelines. DSIR & Institutional Compliance: Spearhead the quality documentation and compliance requirements necessary to secure and maintain Department of Scientific and Industrial Research (DSIR) certification and other government recognition programs. GxP Compliance & Preclinical Traceability: Preclinical Data Integrity: Establish robust mechanisms to ensure absolute traceability and data integrity in preclinical manufacturing, characterization, and testing phases. CRO Oversight: Act as the primary quality auditor for external CROs managing toxicology studies, ensuring strict adherence to GLP guidelines. Assay Qualification: Oversee the qualification and validation of critical analytical assays (e.g., cell counting, purity, identity, and stability testing) required for product release. Quality Systems & Leadership: Perform critical analytical testing for product release and stability, including Viable Cell Counts (VCC) and confirmation of purity. Conduct phenotypic antibiotic susceptibility testing (e.g., Minimum Inhibitory Concentration determination) to establish the biological control profile for the product. QMS Development: Build, implement, and maintain a phase-appropriate Quality Management System (QMS) encompassing deviations, CAPA, change controls, and out-of-specification (OOS) investigations. Team Leadership: Supervise, mentor, and build a high-performing team of QA scientists, compliance specialists, and technicians. Qualifications Education: A Master’s degree (MSc/MPharm) or PhD in Microbiology, Biotechnology, Pharmacy, Biochemical Engineering, or a related discipline. Experience: Extensive, hands-on experience in Quality Assurance leadership within the pharmaceutical or biotechnology sectors, ideally in a startup setting. Proven track record of setting up, validating, or managing a Schedule M or international cGMP compliant manufacturing plant. Direct experience defending quality systems during regulatory audits , managing DSIR certification , and coordinating IBSC approvals. Deep exposure to closed fermentation operations , single-use systems (SUT) , and cleanroom facility engineering/validation. Experience overseeing GLP toxicology studies at CROs and managing preclinical data traceability. Technical Skills: Comprehensive knowledge of facility engineering, HVAC validation, environmental monitoring, and contamination control strategies. Deep understanding of GxP guidelines (GMP, GLP, GDP), biosafety regulations, and Indian CDSCO regulations (Schedule M). Strong expertise in analytical method/assay qualification and validation frameworks. Attributes: Exceptional leadership and communication skills, with a proven ability to manage cross-functional teams and external stakeholders (builders, validators, CROs). Meticulous attention to detail and sharp problem-solving abilities to troubleshoot compliance risks in novel biological processes. A proactive and collaborative mindset, with the agility to thrive and make risk-based decisions in a fast-paced, results-oriented startup environment. How to Apply Please submit your CV and a cover letter detailing your relevant experience and interest in the position to We look forward to hearing from you.