Director of Quality

Driven to uphold the highest standards in biologics quality? Step into this role where your expertise ensures operational integrity and supports the delivery of safe, effective treatments worldwide.

R&D Partners working alongside an early-stage, venture-backed biotechnology company developing innovative cell based therapies for the treatment of serious diseases. Operating at the forefront of translational science, the organisation is advancing a proprietary pipeline from preclinical development towards first-in-human clinical studies. The company offers a highly collaborative, science-driven environment where teams work across discovery research, preclinical development, process development, analytical sciences, translational research, and external partnerships to bring novel therapies to patients.

This is an exciting opportunity to join at a pivotal stage of growth and play a key role in shaping the quality function as the organisation progresses into clinical development.

We are looking for a highly motivated and experienced Quality Assurance professional to lead quality oversight across early clinical development, manufacturing, and clinical supply activities. The successful candidate will ensure compliance with GMP, GCP, and applicable GxP regulations while supporting the development, implementation, and maintenance of a phase-appropriate Quality Management System (QMS). This role will provide strategic leadership for the quality function whilst remaining hands-on in the execution of core QA activities.

A significant focus will be placed on external vendor oversight, GMP batch disposition, clinical data oversight, and regulatory support for first-in-human clinical programmes.

Applicants must have legal authorization to work in the United States.

• Provide end-to-end quality oversight of manufacturing activities, including drug substance and drug product operations conducted at external CDMOs.
• Ensure GMP readiness for clinical supply, including batch record review, deviation management, and lot release activities.
• Partner with CMC colleagues and manufacturing partners to support technology transfer, production campaigns, and release testing.
• Develop and execute clinical supply quality strategies, ensuring compliance across stability programmes, reference standards, and comparability assessments where applicable.
• Collaborate with Clinical Operations and external CROs to ensure GCP compliance, including site audits, trial master file reviews, and investigator oversight.
• Implement and maintain a phase-appropriate QMS supporting GxP compliance, including SOP management, document control, deviations, CAPAs, change control, and training systems.
• Lead qualification, onboarding, auditing, and ongoing oversight of vendors and contract organisations through quality agreements and performance monitoring.
• Provide quality oversight for preclinical and IND-enabling activities, including analytical method validation, bioanalytical testing, toxicology studies, and associated reporting.
• Ensure compliance with applicable FDA, ICH, and global regulatory requirements, including data integrity and documentation standards
• Work cross-functionally with CMC, Clinical, Regulatory, Nonclinical, and Programme teams to embed quality throughout development activities.
• Support responses, inspections, and communications with regulatory authorities as required.
• Act as the quality subject matter expert during preparation for regulatory submissions and early-stage clinical development activities.

• Bachelor's degree or higher in Life Sciences or a related scientific discipline.
• Proven years of experience within the biopharmaceutical industry, including substantial Quality Assurance experience.
• Experience supporting advanced therapy, biologics, cell therapy, gene therapy, or other complex biologic products is highly desirable.
• Strong working knowledge of GMP, GCP, FDA, and ICH requirements.
• Experience managing CRO and CDMO relationships, including vendor qualification, auditing, and oversight.
• Familiarity with electronic quality management systems and document management platforms.
• Experience supporting regulatory submissions and interactions with health authorities is advantageous.
• Previous experience establishing or enhancing Quality Management Systems within a growing organisation is highly desirable.
• Experience operating within a start-up, emerging biotech, or venture-backed environment is preferred.
• Strong communication,…