Head of Quality (Vice President)

About the role

Vedanta Biosciences is a late-stage biopharmaceutical company focused on developing treatments for gastrointestinal diseases. The company's lead asset, VE303, is in a Phase 3 trial for recurrent C. difficile infection. Vedanta uses a unique product engine to develop therapies based on defined consortia of bacteria, leveraging extensive clinical data and advanced manufacturing capabilities.

Responsibilities

• 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
• Take an active mentorship role in developing the Quality team to best serve the business
• Set short-term and long-term goals that are aligned with Vedanta’s corporate and quality goals
• Actively survey and share information on changing regulations and practices that relate 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 (such as FDA, EMA, and ICH) as they apply to products, procedures, and practices
• Assess and make recommendations to ensure the availability of quality resources to staff the Quality efforts required to ensure both compliance with applicable regulations and support of corporate goals
• Establish cooperative relationships with Contract Manufacturing Organizations, parent and 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 our LBPs
• Support development and maintenance of operating and capital expense budgets
• Ensure timelines are met, and costs remain within the established budgets
• Drive the use of strategies, technologies, resources, and processes in support of quality initiatives

Requirements

• 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 to support creative problem-solving
• 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 of, and forward-looking vision for, the application of artificial intelligence (AI) tools within a quality organization