Quality Program Associate
Hybrid · Barcelona, Catalonia, Spain
Job Summary
Quality Program Associate responsible for supporting the creation, maintenance, and execution of quality plans for customer implementation projects in GMP/GxP settings. Activities include assisting with computer system validation (CSV/CSA) deliverables (validation plans, requirements and specifications, IQ/OQ/PQ test protocols, traceability matrices, validation summary reports), coordinating GMP implementation projects, providing support on validation and compliance engagements, and maintaining documentation per ALCOA+ and GDP. The role involves change control, deviation, and CAPA documentation, conducting internal audits to ensure GxP documentation alignment with GAMP 5, preparing validation and quality evidence for customer audits and inspections, supporting external audits, and collaborating with product, engineering, and delivery teams to embed quality into solutions. Candidates should contribute to continuous improvement of templates, SOPs, and best practices and possess a foundational understanding of GMP/GxP concepts, with opportunities to grow in a regulated and global SaaS context.
Required Qualifications
- Bachelor's degree in Pharmacy, Biotechnology, Chemistry, Engineering, Life Sciences, Computer Science, or similar
- 0–2 years of experience (including internships) in quality, validation, regulatory affairs, or project support, ideally within pharma/biotech, a GMP setting, or a regulated software environment
- Familiarity with GMP/GxP concepts and quality systems
- Strong written and verbal English (working language)
- Strong attention to detail, organization, and documentation discipline
- Comfortable working with software tools and digital systems
- Willing to comply with and follow regulations required in regulated environments (ISO standards and GMP)
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