Job Description

The Vall d´Hebron Institute of Oncology (VHIO) Seeks a “Clean room for the production of Advanced Therapies Medicinal Products (ATMPs)”

Reference:2026-43-01

Application deadline: until the position is filled

Number of vacancies: 2

At VHIO, we are setting up a new Clean room for the production of Advanced Therapies Medicinal Products (ATMPs) For the execution of this project, a multidisciplinary working group has been created from various departments within the centre. To complete it, we are looking for a quality assurance professional to participate in the commissioning of the room, implementing the quality system, and once operational, to be responsible for quality assurance.

The mission of the role will be to implement, control and maintain the GMP Quality Assurance System of the Advanced Therapies Accelerator Unit at VHIO. Reporting to the ATMP Clean Room’s Qualified Person. The position is funded by the Advanced Therapies Accelerator AECC Excellence Program.

Requirements

• Intermediate Technical Training or Technical Training Program in Laboratory Science, specializing in biosanitary, biomedical, and/or biotechnological fields; Bachelor's degree in biosanitary fields (Pharmacy, Biology, Chemistry, Biotechnology, and related areas). Doctorate or Master's degree in the biosciences field will be valued.
  

• Demonstrable experience/references in quality system management, preferably in manufacturing processes for human-use medicines or similar (GMPs).
  

• Demonstrated and/or regulated knowledge in Good Manufacturing Practices (GMPs) and/or specific Good Manufacturing Practices for Advanced Therapy Medicinal Products (GMP-ATMPs).
  

• Recommended: Knowledge of regulations and applicable standards for Advanced Therapy Medicinal Products, in Europe and Spain.
  

• English level B1 (Common European Framework of Reference) or equivalent, allowing for comprehensive reading of scientific texts.

Responsibilities – General Functions:

Ensuring compliance with the GMP-ATMPs Standards in the Advanced Therapies Accelerator Unit’s manufacturing activities, regarding document management, creation, follow-up and evaluation of non-conformities/incidences, change controls and risk assessment. Also, monitoring of training and of the validations and qualifications performed to comply with the responsibilities and qualifications described in current GMPs regulations.

Quality Assurance Responsible for monitoring and maintaining the quality management system under the responsibility of the Qualified Person. In general, responsible for ensuring compliance with GMP-ATMPs in the manufacturing activities of the Unit/organization.

In terms of document management maintaining the quality documentation system, creation, follow-up and evaluation of non-conformities, changes, and risks, as well as monitoring training and validations/qualifications executed.

• Establishment and Monitoring of the Process Validation: IQ, OQ, PQ.

• Establishment of the Internal Audit System: Planning and execution.

• Establishment of the Training System: Planning and execution.

• Establishment of the Equipment Control Plan: Calibrations and Qualifications.

• Monitoring and maintenance of the Validation Master Plan.

• Monitoring and maintenance of incidences, deviations, out-of-specifications, investigations, change controls, validations, qualifications, and risk management. Establishment and follow-up of Corrective/Preventive Actions.

• Provides QA support to manufacturing, packaging processes, and batch release to the Qualified Person.

• Assists with external audits (Regulatory Agencies, Certification Bodies, clients, or interested parties) in collaboration with affected or involved Areas/Departments.

Skills

• Initiative, proactive, flexible.

• Organization, coordination, and teamwork skills.

• Oral and written communication skills, assertive.

• Proficiency in office software.

Job Objectives

Guarantee the harmonization and effectiveness of the global quality system/elements (QMS) throughout the company and departments (R&D, Production, QC, Management), providing an overall view of quality assurance.

Additional information:

We offer:

• 📈The possibility of developing your professional career in a competitive environment.

• 🧠To be part of a center that is constantly developing, pursuing excellence in research and collaborating with leading teams.

• 🫱🏻‍🫲🏾We offer and promote a diverse and inclusive environment, and welcome all people equally, regardless of age, disability, gender, nationality, race, religion or sexual orientation.

• 🪴We care about our environment and understand the importance of sustainability. We have the GreenVhio program, which you can be a part of.

Conditions:

• 📝Permanent contract.

• 🗓️Full-time position, 37.5 hours per week.

• 💶Salary according to qualifications and experience following VHIO pay scales.

• 💳Flexible remuneration program (includes restaurant vouchers/cards, transport, medical insurance, and “baby daycare” voucher).

• ⏰Flexible working hours and measures to balance work, family, and personal life, and promote gender equality, as established in the VHIO collective agreement.

• 🗺️24 days of holidays and 6 personal days.
  

• 🎓Fully subsidized Catalan, Spanish, or English courses.

• 🏃‍➡️Take advantage of doing sports at great prices with WellHub

• 🩺You’ll have access to weekly physiotherapy sessions at the office, offered at a reduced price for the team.

Vall d’Hebron Institute Oncology (VHIO) endorses the Requirements and Principles of the European Charter for Researchers, the Code of Conduct for the Recruitment of Researchers promoted by the European Commission and follows Equal Opportunities policies.

On 10th April 2018 VHIO was awarded the “HR Excellence in Research” logo. Our Institute was consequently granted permission to use the HR Excellence in Research Award logo as demonstration of its stimulating and favourable work environment in line with the Charter & Code.