Head of Quality; Vice President

Vedanta Biosciences is a late‑stage biopharmaceutical company developing medicines for the treatment of gastrointestinal diseases. The company’s lead asset is a potential first‑in‑class oral therapy, VE303, in a Phase 3 trial for recurrent C. difficile infection. Vedanta’s pipeline has been built using the company’s industry‑leading product engine for the development of therapies based on defined consortia of bacteria grown from pure clonal cell banks.

The product engine, supported by foundational IP, includes one of the largest libraries of bacteria isolated from the human microbiome, vast clinical datasets, proprietary capabilities in consortium design, and end‑to‑end CGMP manufacturing capabilities at commercial launch scale.

Vedanta Biosciences is looking for an experienced Head of Quality to lead the Quality Assurance (QA), Quality Control (QC), and Clinical Quality Assurance (CQA) functions. The ideal candidate will lead a multi‑faceted team of Quality professionals and deliver phase‑appropriate GXP Quality guidance for Vedanta’s lead asset, VE303, and guide the organization through the maturation of early‑phase development into later‑phase and commercial programs.

• Ensure products, procedures, and practices meet Vedanta's goals and all quality and regulatory standards.
• Facilitate risk‑based decision‑making, highlighting best practices and approaches while maintaining a consultative and collaborative approach.
• Manage, develop, and build the Quality team and its capabilities, serving as an active mentor.
• Set short‑term and long‑term goals aligned with Vedanta’s corporate and quality objectives.
• Actively survey and share information on changing regulations and practices related to Vedanta’s business.
• Collaborate with executive and functional leaders to ensure understanding and adherence to company and Quality Policies, Guidelines, Programs, and Systems.
• Provide expertise and guidance in interpreting government regulations and guidelines (FDA, EMA, ICH) as they apply to products, procedures, and practices.
• Ensure availability of quality resources to staff the Quality efforts required for compliance and support corporate goals.
• Establish cooperative relationships with Contract Manufacturing Organizations, affiliate organizations, and internal departments to improve overall quality.
• Report on Key Performance Indicators and make improvements and adjustments as indicated by changes in trends.
• Lead the expansion of the QMS, including strategic implementation of electronic systems to support internal CGMP capabilities for Live Biotherapeutic Products.
• Support development and maintenance of operating and capital expense budgets, ensuring timelines are met and costs remain within established budgets.
• Drive the use of strategies, technologies, resources, and processes in support of quality initiatives.

• BS/MS in a relevant scientific discipline (e.g., Microbiology, Biochemistry) and 15+ years of relevant professional experience.
• 10+ years of experience in Quality Management with several years in a biotherapeutics manufacturing setting.
• Deep knowledge of cGXP requirements, with an understanding of phase‑appropriate clinical and commercial expectations.
• Experience with FDA, QP, BIMO, and EMA/MHRA inspections and audits.
• Experience directly supporting on‑site production, including responsibility for product disposition.
• A proven track record of leadership, people management, and effective interpersonal and communication skills.
• Ability to prioritize and manage through complex processes/projects.
• Experience in smaller organizations, supporting the development of novel biopharmaceutical technologies and/or products.
• A “can‑do” attitude with a focus on team success, both within Quality and with cross‑functional business partners.
• Some technical knowledge of biologics manufacturing areas, with aptitude to understand the basic science of Vedanta’s production processes.
• Demonstrated understanding and forward‑looking vision for the application of artificial intelligence (AI) tools within a quality organization.

The base pay range for this position is expected to be $275,000 – $315,000…