Supplier Quality Specialist

We are a Contract Development and Manufacturing Organization (CDMO), based in Donostia-San Sebastián, currently undergoing a major growth project. We are driven by an unwavering passion for science and a strong commitment to excellence and people.

Our purpose: to improve people’s lives through groundbreaking advances in biotechnology and gene therapy that help cure rare diseases and cancer.

With a philosophy not just of working together, but growing together, our company culture is built on honesty, excellence, leadership, engagement, ethics, and rigor.

We are a CDMO (Contract Development and Manufacturing Organization), and the trust placed in us by over 50 biotech companies around the world is our greatest endorsement. We develop and manufacture viral vectors (lentiviral), and are among the European leaders operating under EMA and FDA guidelines. The lentiviral vectors produced by VIVEbiotech are used in the treatment of various diseases, including hematologic and solid cancers, as well as rare diseases.

We are looking for you to be part of our Team!

We are looking for a Supplier Quality Specialist to perform this key role in the company.

Your mission will be to ensure the quality management and supervision of suppliers and outsourced activities, ensuring compliance with GMP (21 CFR 210/211, EU GMP) through a risk-based approach, maintaining responsibility for product quality and ensuring that outsourcing does not compromise quality system control.

• Manage the full supplier lifecycle (qualification, approval, re-evaluation and monitoring)
• Conduct documented risk assessments for suppliers based on their impact on quality, sterility and supply chain
• Maintain the Approved Supplier List (ASL) and ensure that only approved suppliers are used
• Develop, review and implement Quality Agreements ensuring that they reflect real GMP responsibilities and operational practices
• Ensure effective supervision of outsourced activities, guaranteeing control over processes that impact quality
• Plan and execute risk-based (on-site/remote) supplier audits, including CAPA tracking
• Monitor supplier performance through KPIs (deviations, CAPAs, rejections, trends)
• Evaluate deviations, changes and complaints related to suppliers, ensuring impact analysis and quality control
• Ensure that supplier changes do not affect product quality without prior QA evaluation
• Supervise storage and transport conditions, ensuring control, monitoring and management of excursions
• Maintain complete, traceable documentation available for regulatory inspections
• Support regulatory inspections by providing evidence of supplier control
• Provide active support in the implementation and continuous improvement of Quality computer systems, including ERP, Document Management and Change Control systems, Deviations and CAPAs
• Support in the review and approval of materials and components for use in production and quality control processes when required
• Review and maintain material master data, including additions, modifications, and retirements of raw materials and components in the corresponding systems
• Provide cross-cutting support to other Quality activities when needed, ensuring alignment with GMP and Quality System requirements
• Support in the execution of projects, including product development, process validations and preparation of technical reports
• Participate and support customer and regulatory audits, ensuring availability of documentation and contributing to inspection preparation
• Proactively propose continuous improvement initiatives aimed at quality, efficiency and cost optimization within its scope of action
• Report to your direct manager any relevant incident, deviation or risk that may impact product quality, regulatory compliance or operations
• Carry out their functions in accordance with the company’s values and quality culture, promoting compliance, integrity and responsibility
• Actively collaborate in teamwork, with flexibility and transversal support to ensure the proper functioning of the team or section
• Work with a focus on continuous improvement in relation to quality, GMP compliance, occupational health and safety and environmental impact
• Maintain an internal and external customer orientation, responding effectively and flexibly to business needs

• University degree related to Biology, Biotechnology or others related to clinical, scientific and/or biomedical areas, with a solid background in Molecular Biology.
• Master’s degree related to one of the areas of knowledge described above.
• GMP Training
• Supplier Management Training
• Knowledge of ATMP (sterile products) is an asset.
• You have at least 3 to 5 years of previous experience in Quality Assurance under GMP regulations
• You have experience in supplier management and audits
• You have experience in deviation and CAPA management
• Experience in sterile products will be an asset
• You have a high level of English (at least C1)
• You demonstrate a high capacity for teamwork and orientation to results.

• You will participate in innovative projects that are constantly updated technologically.
• You will have a competitive salary in line with your profile for this position.
• You will be part of an expert, young, dynamic, innovative and enthusiastic team united by a common purpose, to accompany our clients to advance in the cure of diseases.
• You will enjoy a professional work environment, which is truly distinguished by our humanity and closeness, and where we take care of diversity and inclusion. Diverse points of view, your curiosity, bring diverse capabilities that strengthen our focus and drive our growth.
• We are proud to offer equal opportunities. All individuals receive equal consideration for our open positions, without regard to gender, age, race, religion, identity, sexual orientation, origin, disability, or any other characteristic.