Head of Quality (Vice President)

About Vedanta Biosciences

Vedanta Biosciences is an advanced biopharmaceutical company specializing in treatments for gastrointestinal diseases. Their leading product, VE303, is an oral therapy currently in Phase 3 trials targeting recurrent Clostridioides difficile infections. The company develops therapies using a proprietary platform involving defined bacterial consortia grown from pure clonal cell banks, supported by extensive human microbiome bacterial libraries and clinical data, alongside end-to-end CGMP manufacturing at commercial scale.

Position Overview

Vedanta seeks a seasoned Head of Quality to lead Quality Assurance (QA), Quality Control (QC), and Clinical Quality Assurance (CQA) divisions. This role involves supervising a diverse team to provide GXP-compliant quality oversight as VE303 progresses through clinical phases to commercialization. Key responsibilities include ensuring global clinical trial and product compliance, managing and enhancing quality systems for in-house cGMP manufacturing and QC testing, and overseeing vendor quality through audits and quality agreements.

Key Responsibilities

• Guarantee that all products, procedures, and practices align with Vedanta's objectives and regulatory quality standards.
• Promote risk-based decision-making while fostering collaboration and sharing of best practices.
• Lead recruitment, development, and mentorship of the Quality team to meet business needs.
• Set quality goals consistent with corporate targets and monitor evolving regulatory requirements.
• Collaborate with executives and cross-functional leaders to ensure compliance with quality policies and systems.
• Provide expert interpretation of regulatory guidelines including FDA, EMA, and ICH.
• Evaluate and secure quality staffing and resources to maintain compliance and corporate goals.
• Build cooperative relationships with contractors and internal departments to enhance overall quality.
• Report key quality indicators and implement improvements based on trends.
• Advance the Quality Management System, including the rollout of electronic systems for CGMP support of Live Biotherapeutic Products (LBPs).
• Support budget preparation and ensure adherence to timelines and financial constraints.
• Drive the adoption of innovative strategies and technologies to advance quality objectives.

Qualifications and Experience

• Bachelor's or Master's degree in scientific fields such as Microbiology or Biochemistry.
• Over 15 years of professional experience with at least 10 years in Quality Management, notably within biotherapeutics manufacturing.
• Strong expertise in cGXP regulations reflecting clinical phase and commercial requirements.
• Hands-on experience with inspections and audits by bodies like FDA, EMA, MHRA, QP, and BIMO.
• Proven leadership skills managing complex projects and teams in a GMP environment.
• Background in supporting novel biopharmaceutical product development in smaller organizations.
• Technical understanding of biologics manufacturing processes and an ability to grasp Vedanta's scientific methodologies.
• Forward-thinking regarding the integration of AI tools in quality operations.
• Excellent communication and interpersonal skills, capable of cross-functional collaboration.

Compensation and Additional Information

The anticipated base salary range is $275,000 to $315,000 annually, subject to market conditions, experience, and internal equity. The complete remuneration package includes stock options, a performance bonus target, and benefits. Vedanta is an equal opportunity employer committed to inclusive hiring without discrimination and provides accommodations as legally required.