Director of Quality

We are looking for a Director of Quality to establish and lead a proactive quality function as the organisation progresses through clinical development and prepares for future growth. This position offers the opportunity to influence company-wide quality strategy, working closely with senior leadership to build robust quality systems that support product development, manufacturing, and regulatory compliance. This is an excellent opportunity for someone who enjoys working in a fast-paced biotech environment where they can make a tangible impact and help shape the future of the Quality organisation. Key Responsibilities Own the company\'s Quality Management System (QMS), ensuring compliance with FDA, EMA, ICH, and global GxP requirements. Develop and implement quality policies, procedures, and systems that support organisational growth. Provide quality oversight for manufacturing, analytical testing, clinical operations, and supply chain activities. Lead inspection readiness initiatives and manage regulatory inspections conducted by FDA and other global authorities. Oversee deviations, investigations, CAPAs, change controls, risk assessments, and quality metrics. Establish and maintain supplier quality programmes, including qualification, auditing, and ongoing performance monitoring of CMOs, CDMOs, and external vendors. Drive continuous improvement initiatives to enhance quality processes and operational efficiency. Partner with Technical Operations, Regulatory Affairs, Clinical Development, Manufacturing, and Executive Leadership to ensure quality considerations are integrated across all business functions. Build, mentor, and develop a high-performing Quality team while fostering a strong culture of compliance and continuous improvement. Requirements Bachelor\'s degree in a scientific discipline such as Biology, Chemistry, Biotechnology, Pharmacy, or related field. 10+ years of Quality experience within the biotechnology or pharmaceutical industry. Proven leadership experience within GMP-regulated environments. Strong understanding of Quality Systems, GMP compliance, and global regulatory expectations. Experience supporting commercial or late-stage clinical manufacturing operations. Hands-on experience managing regulatory inspections, supplier quality, and external manufacturing oversight. Excellent communication skills with the ability to influence stakeholders across all levels of the organisation. Desirable Experience Experience supporting biologics, gene therapy, cell therapy, or other advanced therapeutic products. Knowledge of phase II/III clinical development through commercial manufacturing. Experience implementing or improving electronic Quality Management Systems (eQMS). Previous experience within a growing or venture-backed biotech company is highly desirable. #J-18808-Ljbffr Medella Life