Director, Cell Therapy Quality Management

AstraZeneca; Barcelona; Híbrido; EUR 90.000 - 120.000; Jornada completa

Descripción de la vacante

A global pharmaceutical company in Barcelona is seeking a Director for Cell Therapy Quality Management. The role involves ensuring quality assurance processes are aligned with global standards for clinical trials. The ideal candidate will have over 7 years of relevant experience and strong knowledge of clinical trial regulations and process improvement methodologies. The position requires excellent communication and collaboration skills and offers a hybrid working model with 3 days in-office and 2 days remote per week.

Formación

• 7 years of relevant operational experience in Drug Development.
• Strong knowledge of Clinical Trials regulations (ICH GCP, FDA, EMA).
• Experience with process improvement methodologies like Lean Six Sigma.

Responsabilidades

• Ensure CTCO trials adhere to established quality standards.
• Support development using quality-related data.
• Communicate quality-related insights to the CTCO organization.

Conocimientos

Strong written and verbal communication

Collaboration and negotiation skills

Problem-solving

Time management

Educación

Bachelor of Science in an appropriate discipline

Descripción del empleo

Location

Barcelona - Spain (3 days working from the office and 2 days working from home)

Introduction

Director, Cell Therapy Quality Management (Dir. CT QM) role will work in a collaborative manner with other members of the Cell Therapy Clinical Operations (CTCO) Business Processes, Quality & Learning (BPQL) team in order to provide expert quality advice and coaching so as to support the successful delivery of Cell Therapy Programmes.

The Dir. CT QM role will function to support the teams across CTCO in order to ensure that all CTCO trials are prepared for both internal and external audits and inspections.

The Dir. CT QM role has a specific area of expertise within CTCO BPQL in the following manner:

• Work closely with CTCO Process Owners in order to ensure that any established processes adhere to AZ global quality standards.
• Deliver or drive the development of quality‑related initiatives and continuous improvement programmes that would support improved Quality and Compliance within CTCO trials and within CTCO‑related processes and initiatives.
• First line of Qulity support to all CTCO trials and CTCO‑related initiatives.
• To operate within established AstraZeneca Quality group, including but not limited to the Cell Therapy Quality Network (CTQN), and Process Quality, Learning & Transformation (PQLT).

Accountabilities

• CT BPM work closely with the BPQL team, ensuring:

• Insights related to CTCO‑specific process‑related issues requiring corrective actions are documented for potential future process improvements.
• Process KPIs & measurement: Support development, using quality‑related data to inform process and business improvement activities.
• Perform effectiveness checks as needed to support the remediation of study‑related CAPAs and if needed to verify the uptake and adoption of new and changed CTCO‑related processes.
• Escalate, as needed, to 2nd Line Quality and the broader CTQN any issues or risks related to any CTCO‑related studies or initiatives.
• Communicate on a routine basis, relevant quality‑related insights and feedback to the greater CTCO organization.

Education, Qualifications, Skills and Experience

Essential

• Bachelor of Science in an appropriate discipline or equivalent experience.
• 7 years of relevant operational and/or quality experience in Drug Development within a pharmaceutical or clinical background.
• Strong knowledge of business process, technology and Clinical Study information knowledge.
• Demonstrated time management acumen and proven skills to deliver responses and support.
• Experience in working successfully and collaboratively with both internal and external partners.
• Demonstrated strong written and verbal communication and influencing skills, negotiation, collaboration, problem solving, presentation, knowledge transfer (mentoring), conflict management and interpersonal skills.
• Strong knowledge of Clinical Trials related international regulations, guidelines and standards (ICH GCP, FDA, EMA regulations and guidelines as minimum), as well as AZ internal standards and procedures, across functions.
• Ability to effectively influence and communicate; ability to engage and collaborate across boundaries with problem solving focus.
• Ability to manage multiple competing priorities, demonstrating a growth mindset, innovation, ownership and accountability.

Desirable

• Strong reputation within the business and industry.
• Strong understanding and knowledge regarding Cell Therapy‑relevant procedures.
• Experience of utilizing standard process improvement methodologies (e.g. Lean Six Sigma) to identify root causes of process issues and identify areas of process improvement.
• Experience in the development and management of Business Process to deliver business performance.

Date Posted 04-dic-2025

Closing Date 09-ene-2026

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry‑leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non‑discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.