About this role
About Us ten23 health is a human-centric and sustainable strategic partner of choice for the pharmaceutical industry and biotech start-ups for the development, manufacture, and testing of tomorrow’s medicines. We support our clients in developing differentiated, stable, usable, and safe injectable treatments for patients. Your mission We are seeking a dynamic and highly experienced Head of Quality & GMP Operations to lead and evolve our Quality Management Systems (QMS) and ensure unwavering compliance within our manufacturing environment. This pivotal role requires a seasoned quality leader who can not only manage complex quality processes but also drive cultural transformation, build high-performing teams, and strategically align quality with business objectives.<br><br>Your responsibilities will include, <br><ul><li>Lead the development, optimization, and remediation of robust Quality Management Systems (QMS) in alignment with global GMP regulations (FDA, EMA, ICH).</li><li>Expertly manage core quality processes including deviations, CAPAs, change control, document management, and comprehensive audit readiness.</li><li>Apply deep understanding of aseptic processing principles, environmental monitoring, cleanroom behaviours, and sophisticated contamination control strategies to ensure product integrity.</li><li>Champion and lead significant cultural and operational transformation initiatives within the quality function and across the organization.</li><li>Build, reshape, and continuously foster a strong quality culture within a dynamic and fast-paced environment.</li><li>Drive accountability for quality and compliance across all cross-functional teams, extending beyond the Quality Assurance department.</li><li>Create and champion an environment where compliance goals are seamlessly integrated with and actively support broader business objectives.</li><li>Mentor, coach, and develop Quality Assurance professionals, fostering a high-performing and engaged team.</li><li>Work collaboratively and effectively with manufacturing, technical operations, and supply chain teams, understanding and supporting their operational priorities while consistently upholding stringent quality standards.</li><li>Capable of engaging, influencing, and communicating effectively at all organizational levels, from floor staff to executive leadership.</li><li>Transparent, persuasive, and adept at leading through influence, skilfully managing resistance, and building crucial buy-in for new systems, tools, and ways of working.</li><li>Drive efficiency by simplifying and streamlining QA processes without compromising compliance or effectiveness.</li><li>Make informed, data-driven decisions, understand when escalation is necessary, and apply sound risk management principles to QA decision-making and process optimization.</li></ul><br> Your profile We are looking for someone with:<br><ul><li>Proven experience in a GMP-regulated environment is essential.</li><li>Demonstrated leadership in building, optimizing, or remediating Quality Management Systems (QMS) in line with global GMP regulations (FDA, EMA, ICH).</li><li>Strong track record managing end-to-end quality processes including deviations, CAPAs, change control, document management, and audit readiness.</li><li>Deep understanding of aseptic processing principles, environmental monitoring, cleanroom behaviours, and contamination control strategies.</li><li>Exceptional leadership skills with a proven ability to drive cultural and operational transformation.</li><li>Demonstrated ability to build and foster a strong quality culture.</li><li>Highly collaborative with strong experience working closely with manufacturing, tech ops, and supply chain teams.</li><li>Excellent communication, negotiation, and influence skills, capable of engaging diverse stakeholders.</li><li>A strategic thinker with a pragmatic approach to problem-solving and process improvement.</li><li>Strong analytical skills, capable of making data-driven decisions and applying risk management effectively.</li></ul> Why us? We offer a dynamic environment where you can contribute meaningfully, collaborate with exceptional minds, and unlock your full potential.<br> <br>Here's what sets ten23 apart:<br><ul><li>A valuable and impactful career development opportunity in an inspiring environment </li><li>Flexible working arrangements and environment with an open culture and diverse workforce </li><li>The opportunity to work with and learn from highly qualified and experienced employees</li><li>Our learning and self-developing culture offers a wide range of training options </li><li>Competitive pension fund plan, annual bonus, and other financial and non-financial benefit </li></ul>At ten23 we believe in self-responsibility and mutual trust. Therefore, we will provide our employees as much flexibility as possible and limit any bureaucracy to a minimum, whilst ensuring compliance with all applicable laws. Contact For more information and clarification, please connect Amrith ([email protected]) from our Talent team!