Clinical Development & Quality Operations Specialist

Clinical Development & Quality Operations Specialist

Seeking a cross-functional Clinical Development & Quality Operations Specialist to support the development of our lead CAR-T program (GYA01) in relapsed/refractory AML. Ideal for a GxP quality professional looking to grow into clinical development and advanced therapies. (LinkedIn only applications will not be considered - please see application procedure below.)

Contract type: Full-time, open-ended (contrato indefinido)

Target starting date: September – October 2026

Location: Barcelona or Madrid, with regular travel to clinical sites and external partners as needed. Remote working arrangements may also be considered.

About Gyala Therapeutics

Gyala Therapeutics is a clinical-stage biotechnology company developing innovative CAR-T cell therapies for patients with hematological malignancies. The company’s lead program, GYA01, is currently being evaluated in a first-in-human Phase I/IIa clinical trial in patients with relapsed or refractory acute myeloid leukemia (AML), a disease with a significant unmet medical need and limited therapeutic options.

Gyala is at an important stage of development, combining innovative science with the operational challenges of advancing an advanced therapy medicinal product (ATMP) through clinical development. We are looking for a highly motivated professional who wants to contribute directly to the advancement of a potentially transformative therapy for patients.

Position Summary

The Clinical Development & Quality Operations Specialist will play a key role in supporting Gyala’s clinical development activities and strengthening the company’s quality operations, with the opportunity to directly contribute to the development of an innovative CAR-T program within a clinical-stage biotechnology company.

This highly cross-functional role will act as an interface between clinical sites, CROs, manufacturing partners, quality functions, regulatory teams, and external vendors, working closely with the Chief Medical Officer, Chief Operating Officer, and external Quality Assurance support.

The successful candidate will bring hands-on quality systems experience as the core foundation for this role, combined with strong organizational and communication skills, to help ensure that clinical, manufacturing, and quality activities are effectively coordinated and documented. Experience in early-phase clinical operations and advanced therapies is a distinct advantage.

Key Responsibilities

Clinical Development and Operational Support

· Support the coordination and advancement of Gyala’s clinical development program.

· Support the organization, maintenance, and review of clinical trial and program documentation.

· Manage the collection, consolidation, and review of clinical, manufacturing, operational, and safety information

· Prepare patient summaries, clinical updates, program reports, and other materials to support internal governance and decision-making.

· Support coordination of activities with CROs, clinical sites, manufacturing facilities, and external partners, including activities related to CAR-T manufacturing and investigational product logistics.

Quality Operations

· Support the maintenance and continuous improvement of Gyala’s Quality Management System (QMS).

· Coordinate quality activities including deviations, CAPAs, audit findings, quality records, and controlled documentation.

· Support supplier oversight activities, quality agreements, audits, and regulatory inspections.

· Ensure appropriate documentation practices and compliance with applicable GCP, GMP, and internal quality requirements.

· Act as the day-to-day operational interface with external Quality Assurance support.

Candidate Profile

• Bachelor’s or Master’s degree in Life Sciences, Biotechnology, Biomedical Sciences, Pharmacy, Immunology, or a related scientific discipline.
• Previous hands-on experience in Quality Assurance, Quality Operations, or related GxP quality functions within biotechnology, pharmaceutical, or healthcare environments is essential, including experience with Quality Management Systems, GCP/GMP documentation, deviations, CAPAs, audits, and supplier oversight.
• Experience supporting early-stage clinical development programs or clinical operations is a distinct advantage.
• Experience with ATMPs, cell therapy, gene therapy, CAR-T, immunotherapy, or oncology programs is an advantage.
• Strong organizational skills, attention to detail, and ability to manage multiple priorities.
• Ability to understand, interpret, and communicate scientific information effectively in a multidisciplinary environment.
• Proactive, collaborative, and solution-oriented mindset.
• Fluent English and Spanish are essential.

Application Procedure

Please send your CV and a brief cover letter (Subject: Clinical Development & Quality Operations Specialist) outlining your motivation, relevant experience, and your starting date availability to Claudio Santos ([email protected]) before 4^th August 2026. LinkedIn only applications will not be considered.