About the Role

As a QA Manager — GLP, you will partner with cross-functional teams to deliver measurable impact within the Vanta Bioscience ecosystem. This role blends hands-on execution of quality assurance activities with strategic quality leadership. You will be responsible for managing the Good Laboratory Practice (GLP) Quality Assurance Unit (QAU), ensuring that all non-clinical safety studies, bioanalytical operations, and laboratory processes comply with stringent regulatory standards (OECD, FDA, EMA). You will lead a team of QA professionals, drive a culture of data integrity and continuous improvement, and act as a key liaison during regulatory inspections.

Responsibilities

• Quality System Management: Oversee the development, implementation, and maintenance of the GLP Quality Management System (QMS), including SOPs, training records, and document control.
• Study Audit & Inspection: Conduct and oversee process-based, study-based, and facility-based GLP audits. Review and approve study protocols, amendments, and final reports for GLP compliance.
• Regulatory Compliance: Ensure strict adherence to OECD GLP principles, FDA 21 CFR Part 58, and other applicable international regulatory guidelines.
• Deviation & CAPA Management: Oversee the investigation of deviations, Out-of-Specification (OOS) results, and non-conformances. Ensure the implementation of robust Corrective and Preventive Actions (CAPA).
• Data Integrity: Champion data integrity initiatives across the laboratory, ensuring ALCOA+ principles are strictly followed in all paper and electronic records (e.g., LIMS, Empower, Chromeleon).
• Vendor & Supplier Qualification: Oversee the qualification, approval, and periodic auditing of critical vendors, subcontractors, and computerized systems.
• Inspection Readiness: Lead site readiness for internal audits, client audits, and regulatory authority inspections (e.g., FDA, EMA, NGCMA). Act as a primary host and spokesperson during regulatory inspections.
• Team Leadership: Recruit, train, mentor, and manage a high-performing team of QA Specialists and Auditors. Set departmental goals and conduct performance evaluations.
• Continuous Improvement: Proactively identify areas for process optimization within the QMS and laboratory operations to enhance efficiency while maintaining strict compliance.

Requirements

• Education: M.Sc., M.Pharm, or Ph.D. in Life Sciences, Chemistry, or a related scientific discipline.
• Experience: 8 to 12 years of progressive quality assurance experience in a GLP-regulated environment (CRO, pharmaceutical, or biotech industry), with a minimum of 3 years in a managerial or leadership role.
• Regulatory Expertise: Deep, practical knowledge of OECD and FDA GLP regulations, GxP guidelines, and data integrity standards.
• Auditing Skills: Proven experience in conducting diverse GLP audits and successfully hosting/facing regulatory inspections.
• Technical Acumen: Familiarity with bioanalytical methodologies (LC-MS/MS, ELISA) and laboratory information management systems (LIMS).
• Leadership Skills: Demonstrated ability to lead, motivate, and develop a QA team. Strong conflict resolution and decision-making capabilities.
• Communication: Exceptional written and verbal communication skills, with the ability to interact authoritatively and collaboratively with scientists, study directors, and senior management.

Benefits

At Vanta Bioscience, we invest in our people because they are the foundation of our scientific and operational excellence. We offer a comprehensive benefits package designed to support your professional growth and personal well-being:

• Health & Wellness: Comprehensive medical, dental, and vision insurance coverage for you and your dependents.
• Financial Security: Competitive salary commensurate with experience, employer-provided life and accidental insurance, and retirement savings/provident fund benefits.
• Work-Life Balance: Generous paid time off (PTO), company holidays, and supportive leave policies.
• Career Growth: Structured career development pathways, access to advanced regulatory training programs, and opportunities to attend industry conferences.
• Work Environment: A collaborative, state-of-the-art GxP facility in Shamirpet designed to foster innovation, teamwork, and uncompromised quality.
• Commuter Support: Transportation assistance/facilities for easy commute to the Shamirpet campus.

Interested candidates are encouraged to apply and become a part of our mission to advance scientific research and drug development with the highest standards of quality and compliance.