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Title:                   Head of Quality (Vice President)

Location:           Cambridge, MA

Reports to:        Chief Operating Officer

About Vedanta Biosciences:

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.

The Role:

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. In particular, the Head of Quality should have experience leading an organization through the maturation of early-phase development into later-phase and commercial programs.

The successful candidate will oversee clinical trial and product compliance globally by managing and improving existing quality systems and ensuring appropriate controls for Vedanta's in-house cGMP manufacturing capabilities and internal QC testing. This includes expanding the existing Quality Management System (QMS), development of documents, training of personnel, and quality oversight of Live Biotherapeutic Product (LBP) manufacturing.

Vedanta uses third-party vendors for analytics and final fill/finish manufacturing; the Head of Quality will handle QA aspects of these vendors through site audits, establishment of Quality Agreements, major deviation review, and batch disposition/release. Additionally, the Head of Quality will oversee and guide QC personnel responsible for both internal and external analytical testing for Drug Substance / Drug Product release, stability, and product characterization.

As VE303 advances toward commercial readiness, the Head of Quality will lead process validation activities, including planning and execution of Process Performance Qualification (PPQ) batches. The Head of Quality will also collaborate with a Qualified Person (QP), ensuring compliance with EU GMP requirements.  The Head of Quality will manage PAI and BIMO inspection readiness and QA support of post-approval pharmacovigilance systems. Knowledge of computerized system validation and Annex 11/Part 11 is critical to success in the role.

Here's What You'll Do:

• 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

The base pay range for this position is expected to be$275,000 - $315,000annually; however, the base pay offered may vary depending on market dynamics, experience, internal equity, and job-related knowledge, skills, and capabilities. The total compensation package for this position also includes stock options, a target annual bonus, and benefits.