Quality Assurance Manager of Vhio’s Clean Room

Reporting to the Clean Room - Advanced Therapies Medicinal Products (ATMPs) Qualified Person. 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. The position is funded by the Advanced Therapies Accelerator AECC Excellence Program.

**Education and qualifications**

**Required**

• University degree in biosanitary fields (Pharmacy, Biology, Chemistry, Biotechnology, and related areas).
• Fluency in Catalan, Spanish, English (business level).

**Experience and knowledge**

**Required**

• 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).

**Desired**

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

**Main responsibilities and duties**

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

**Labour conditions**

• Full-time position: 40h/week.
• Starting date: immediate.
• Gross annual salary: 30 000 - 38 000 euros /// (Salary ranges are consistent with our Collective Agreement pay scale).
• Contract: Technical and scientific activities contract linked to the project

**What can we offer?**

• Incorporation to Vall d’Hebron Research Institute (VHIR), a public sector institution that promotes and develops the biomedical research, innovation and teaching at Vall d'Hebron University Hospital (HUVH), the biggest hospital of Barcelona and the largest of Catalan Institute of Health (ICS).
• A scientific environment of excellence, highly dynamic, where high-end biomedical projects are continuously developed.
• Continuous learning and a wide range of responsibilities within a stimulating work environment.
• Individual training opportunities.
• Flexible working hours.
• 23 days of holidays + 9 personal days.
• Flexible Remuneration Program (including dining checks, health insurance, transportation and more)
• Corporate Benefits: platform through which you can obtain significant discounts on travel, culture, technology, gastronomy, sports... among many others.
• Healthy Offering: choose from a variety of wellbeing focused activities to be the healthiest you.

**Deadline to apply: 04-06-2025**

• VHIR embraces Equality and Diversity. As reflected in our values we work toward ensuring inclusion and equal opportunity in recruitment, hiring, training, and management for all staff within the organization, regardless of gender, civil status, family status, sexual orientation, gender identity and expression, religion, age, functional diversity or ethnicity._