Director QA, GMP External Operations (Cell and Genetic Therapies)

TL;DR

Director QA, GMP External Operations (Cell and Genetic Therapies): Leading end-to-end quality oversight for external CDMO operations in cell and gene therapy with an accent on batch disposition, compliance, and continuous improvement. Focus on building strategic relationships with stakeholders, driving technical risk mitigation, and ensuring adherence to global regulatory standards.

Location: Hybrid role based in Paddington, UK (requires on-site presence up to 3 days per week).

Company

hirify.global is a global biotechnology company dedicated to scientific innovation and the development of transformative medicines.

What you will do

• Establish and maintain quality oversight for external CDMO/CTO operations across development and commercial manufacturing.
• Lead continuous quality improvements and drive deviation reduction while ensuring timely resolution of CAPAs.
• Act as the primary SME for CDMO quality management systems and global change control implementation.
• Represent Quality in regulatory inspections, audits, and health authority interactions.
• Collaborate with cross-functional partners to lead technical risk mitigation and operational excellence initiatives.
• Mentor team members and foster a culture of quality and compliance across the organization.

Requirements

• 10+ years of experience in a regulated pharmaceutical environment, with at least 5 years in a management or supervisory role.
• In-depth knowledge of global health regulatory agencies and GXP life cycle in Cell & Gene therapy or Biologics.
• Proven expertise in batch disposition, root cause analysis, and operational excellence methodologies (LEAN, Six Sigma).
• Strong communication and influencing skills to build relationships with internal and external stakeholders.
• Must be based in or able to work from the Paddington, UK office as part of a hybrid work arrangement.

Nice to have

• Master’s degree in a relevant field.
• Specific QA operational experience for Autologous Cell Therapy operations.
• Broad technical knowledge in aseptic manufacturing, analytical assays, and fill/finish processes.

Culture & Benefits

• Hybrid work model offering flexibility between remote and on-site work.
• Opportunity to work at the forefront of innovative cell and gene therapy development.
• Commitment to equal employment opportunity and inclusive workplace culture.
• Professional development and talent building within a global biotech environment.