Quality and Manufacturing Manager

Gyala Therapeutics; Barcelona; Híbrido; EUR 40.000 - 70.000; A tiempo parcial

Descripción de la vacante

Gyala Therapeutics is seeking a Quality and Manufacturing Manager to lead operational and quality activities for CAR-T therapies. This part-time role involves overseeing quality compliance and coordinating with production sites, offering a unique opportunity in an innovative biotech focused on advancing patient treatment options.

Formación

• Minimum of 2 years' experience in GMP manufacturing and quality management.
• Strong knowledge of EU GMP requirements for ATMPs.
• Fluency in Spanish and English.

Responsabilidades

• Maintain and oversee the Quality Management System (QMS).
• Coordinate operations with external GMP manufacturing sites.
• Support regulatory filing preparations.

Conocimientos

Communication

Leadership

Organizational skills

Educación

Degree in Pharmacy, Biology, or Biotechnology

Descripción del empleo

Get AI-powered advice on this job and more exclusive features.

Continue with Google Continue with Google

Continue with Google Continue with Google

Continue with Google Continue with Google

Continue with Google Continue with Google

Continue with Google Continue with Google

Direct message the job poster from Gyala Therapeutics

Chief Executive Officer at Pulmobiotics and Gyala Therapeutics, EIR at Invivo Capital

Position Title : Quality and Manufacturing Manager

Location : Hybrid (Barcelona-based preferred, with regular travel to Valencia and abroad as needed)

Reports to : Head of Operations

Contract Type : Part-Time / Freelance / Consultancy (to be agreed based on candidate profile)

Remuneration : competitive and commensurate with experience and qualifications

Preferred starting date : 1 st September 2025

About Gyala Therapeutics

Gyala Therapeutics is a biotech company focused on the development of innovative CAR-T cell therapies for the treatment of hematological malignancies. Our lead program, CART84, is an investigational, autologous, CD84-targeting CAR-T cell product about to enter a Phase I clinical trial for the treatment of acute leukemia. We are a passionate, science-driven team dedicated to developing transformative therapies for patients with unmet medical needs. Gyala Therapeutics is an equal opportunity employer, and we celebrate diversity, striving to foster an inclusive environment for all our employees.

Position Overview

Gyala Therapeutics is seeking an experienced and motivated Quality & Manufacturing Manager (Part-Time) to take operational and quality leadership for our CAR-T manufacturing activities during the upcoming clinical trial and beyond. This pivotal, part-time role will be responsible for coordinating hospital-based GMP production sites, overseeing Gyala’s Quality Management System (QMS), and eventually overseeing technology transfer to additional manufacturing sites.

The role is ideal for an experienced professional looking to contribute their expertise to an innovative early-stage biotech on a flexible basis and could be structured as a part-time employment contract or consultancy agreement.

Key Responsibilities

• Maintain and oversee Gyala’s internal Quality Management System (QMS), ensuring timely management of deviations, CAPAs, change controls, and quality documentation.
• Act as Gyala’s operational and quality interface with external GMP manufacturing sites for lentivirus and CAR-T manufacturing activities, ensuring effective coordination and oversight.
• Ensure that manufacturing, quality control, and documentation activities at external production sites are performed in full compliance with GMP, GCP, and applicable regulatory requirements.
• Oversee Quality Control (QC) activities at production sites, ensuring appropriate execution, documentation and timely product release.
• Lead quality oversight activities for external manufacturing partners, including the review and approval of batch records, deviations, investigations, change controls, and product release documentation.
• Lead technical and quality oversight of future technology transfer projects, including process transfer planning, documentation review, and the negotiation of technical and quality agreements.
• Support the preparation and submission of quality and CMC sections for regulatory filings (e.g. IMPD amendments, INDs, future BLA / MAAs).
• Provide subject matter expertise in quality, GMP, and manufacturing operations and ATMP regulatory requirements to cross-functional project teams.
• Contribute to the strategic manufacturing roadmap for Gyala’s lead program and pipeline assets.
• Author technical and quality documents including SOPs, protocols, reports, and related documentation.

Candidate Profile

Essential Qualifications and Experience :

• Degree in Pharmacy, Biology, Biotechnology, or a related life sciences discipline.
• Minimum of 2 years’ experience in GMP manufacturing and quality management within cell therapy, gene therapy, or biologics.
• Strong knowledge of EU GMP requirements for ATMPs, including QMS, batch release, QC, deviations, CAPA, and change control processes.
• Proven experience coordinating external manufacturing activities
• Familiarity with regulatory frameworks for ATMPs, including IMPDs, INDs, and clinical trial operations.
• Strong organizational, communication, and leadership skills.
• Fluency in both Spanish and English.
• Experience taking a cell or gene therapy product into clinical trials or to market.
• Experience leading technology transfer processes.
• Knowledge of lentiviral vector manufacturing processes and quality requirements.
• Prior experience working in an early-stage biotech or clinical-stage start-up environment.

Why Join Us

This is a unique opportunity to join a dynamic, science-driven company at a pivotal stage of growth. As a key member of our team, you’ll play a central role in delivering a first-in-class CAR-T therapy to patients and shaping the future manufacturing strategy of Gyala Therapeutics.

Application Procedure

Please send a cover letter (highlighting your fit and interest), CV, two references, and your availability to Claudio Santos ( ) with the subject “Quality and Manufacturing Manager” by 7 July 2025.

Seniority level

Seniority level

Mid-Senior level

Employment type

Employment type

Part-time

Job function

Job function

Management and Manufacturing

Referrals increase your chances of interviewing at Gyala Therapeutics by 2x

Get notified about new Manufacturing Manager jobs in Barcelona, Catalonia, Spain .

External Operations Quality Assurance Manager

Operations Store Manager Spain (They / She / He)

INGENIERO / A RESPONSABLE DE FABRICACIÓN JUNIOR

Digital Operations & Transformation Manager

Strategy & Operations Manager – Life Sciences Sector

Commercial Operations Manager, EMEA and Asia Pacific

We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.

J-18808-Ljbffr