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.

Your responsibilities will include,  

• Lead the development, optimization, and remediation of robust Quality Management Systems (QMS) in alignment with global GMP regulations (FDA, EMA, ICH).
• Expertly manage core quality processes including deviations, CAPAs, change control, document management, and comprehensive audit readiness.
• Apply deep understanding of aseptic processing principles, environmental monitoring, cleanroom behaviours, and sophisticated contamination control strategies to ensure product integrity.
• Champion and lead significant cultural and operational transformation initiatives within the quality function and across the organization.
• Build, reshape, and continuously foster a strong quality culture within a dynamic and fast-paced environment.
• Drive accountability for quality and compliance across all cross-functional teams, extending beyond the Quality Assurance department.
• Create and champion an environment where compliance goals are seamlessly integrated with and actively support broader business objectives.
• Mentor, coach, and develop Quality Assurance professionals, fostering a high-performing and engaged team.
• Work collaboratively and effectively with manufacturing, technical operations, and supply chain teams, understanding and supporting their operational priorities while consistently upholding stringent quality standards.
• Capable of engaging, influencing, and communicating effectively at all organizational levels, from floor staff to executive leadership.
• Transparent, persuasive, and adept at leading through influence, skilfully managing resistance, and building crucial buy-in for new systems, tools, and ways of working.
• Drive efficiency by simplifying and streamlining QA processes without compromising compliance or effectiveness.
• Make informed, data-driven decisions, understand when escalation is necessary, and apply sound risk management principles to QA decision-making and process optimization.

We are looking for someone with:

• Proven experience in a GMP-regulated environment is essential.
• Demonstrated leadership in building, optimizing, or remediating Quality Management Systems (QMS) in line with global GMP regulations (FDA, EMA, ICH).
• Strong track record managing end-to-end quality processes including deviations, CAPAs, change control, document management, and audit readiness.
• Deep understanding of aseptic processing principles, environmental monitoring, cleanroom behaviours, and contamination control strategies.
• Exceptional leadership skills with a proven ability to drive cultural and operational transformation.
• Demonstrated ability to build and foster a strong quality culture.
• Highly collaborative with strong experience working closely with manufacturing, tech ops, and supply chain teams.
• Excellent communication, negotiation, and influence skills, capable of engaging diverse stakeholders.
• A strategic thinker with a pragmatic approach to problem-solving and process improvement.
• Strong analytical skills, capable of making data-driven decisions and applying risk management effectively.

We offer a dynamic environment where you can contribute meaningfully, collaborate with exceptional minds, and unlock your full potential.
 
Here's what sets ten23 apart:

• A valuable and impactful career development opportunity in an inspiring environment  
• Flexible working arrangements and environment with an open culture and diverse workforce  
• The opportunity to work with and learn from highly qualified and experienced employees
• Our learning and self-developing culture offers a wide range of training options  
• Competitive pension fund plan, annual bonus, and other financial and non-financial benefit 

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.

For more information and clarification, please connect Amrith (amrith.kiran@ten23.health) from our Talent team!