Head of Quality

The Head of Quality at Vedanta Biosciences will be responsible for leading the Quality Assurance, Quality Control, and Clinical Quality Assurance functions. They will oversee clinical trial and product compliance globally, manage and improve existing quality systems, and ensure appropriate controls for in-house manufacturing capabilities. The role also involves managing third-party vendors, overseeing and guiding QC personnel, and ensuring inspection readiness and QA support. The Head of Quality will play a key role in developing the Quality team and setting goals aligned with Vedanta's corporate and quality objectives. They should have deep knowledge of cGXP requirements and experience in biotherapeutics manufacturing.

• Lead the Quality Assurance (QA), Quality Control (QC), and Clinical Quality Assurance (CQA) functions
• Provide phase-appropriate GXP Quality guidance for investigational programs
• Oversee clinical trial and product compliance globally
• Manage and improve existing quality systems
• Expand the existing Quality Management System (QMS)
• Develop documents and train personnel
• Provide quality oversight of Live Biotherapeutic Product (LBP) manufacturing
• Handle QA aspects of third-party vendors through site audits, establishment of Quality Agreements, major deviation review, and batch disposition/release
• Oversee and guide QC personnel responsible for external analytical testing
• Manage PAI and BIMO inspection readiness and QA support of post-approval pharmacovigilance systems
• Ensure products, procedures, and practices meet quality and regulatory standards
• Facilitate risk-based decision-making
• Manage, develop, and build the Quality team
• Set short-term and long-term goals aligned with corporate and quality goals
• Stay updated on changing regulations and practices
• Collaborate with executive and functional leaders to ensure adherence to company and Quality Policies, Guidelines, Programs, and Systems
• Provide expertise and guidance in interpreting government regulations and guidelines
• Assess and recommend quality resources to support compliance and corporate goals
• Establish cooperative relationships with external organizations and internal departments
• Report on Key Performance Indicators and make improvements as needed
• Lead the expansion of the QMS and implementation of electronic systems
• Support budget development and maintenance
• Ensure timelines and costs are met
• 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), 15+ years of relevant professional experience
• 10+ years' 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, 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

• Competitive salary and benefits package
• Opportunity to lead and manage a multi-faceted team of Quality professionals
• Deliver phase-appropriate GXP Quality guidance for investigational programs
• Oversee clinical trial and product compliance globally
• Expand the existing Quality Management System (QMS)
• Develop documents and provide training to personnel
• Quality oversight of Live Biotherapeutic Product (LBP) manufacturing
• Handle QA aspects of third-party vendors through site audits and establishment of Quality Agreements
• Oversee and guide QC personnel responsible for external analytical testing
• 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
• Opportunity to set short-term and long-term goals aligned with corporate and quality goals
• Actively survey and share information on changing regulations and practices
• Collaborate with executive and functional leaders to ensure adherence to company and Quality Policies, Guidelines, Programs, and Systems
• Establish cooperative relationships with Contract Manufacturing Organizations, parent and affiliate organizations, and internal departments
• 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
• Support development and maintenance of operating and capital expense budgets
• Drive the use of strategies, technologies, resources, and processes in support of quality initiatives
• Opportunity to work in a pioneering company in the field of microbiome therapies
• Equal employment opportunity and non-discrimination policy
• Reasonable accommodations for qualified individuals with disabilities
• COVID-19 vaccination requirement with accommodations for qualifying medical conditions or religious objections.