Are you looking for the next challenge in your career? Would you like to be part of an exciting highly qualified team of professionals in an international environment? We are currently looking for a qualified Senior GxP / AI Compliance Business Analyst Join an international division and work alongside with some of the most talented engineers and technicians from all over the world. Your

benefits:
• Competitive Salary.
• Long-term secure contract.
• International Project with top technologies
• Possibility of working remotely with a versátil schedule.
• Integration in a highly qualified team of professionals.
• Travel abroad with your project.
• Specialized training and continuous professional development.
• Social benefits and flexible compensation plan.

Key Responsibilities
• Scope / Content Leadership: Independently manage end-to-end business analysis workstreams without guidance, tackling problems with emerging ambiguity, adapting standard frameworks, mentoring junior/intermediate BAs, and proactively shaping team ways of working.
• Accountability & Problem Solving: Lead the analysis of complex business problems, perform thorough domain research, drive root cause analysis, deliver comprehensive requirements, and proactively identify needs-solution discrepancies to propose creative improvements.
• Stakeholder Management & Orchestration: Build reliance across a diverse range of cross-functional stakeholders to act as a trusted advisor; facilitate alignment workshops and risk-review sessions across siloed departments (Legal, Quality Assurance, Software Engineering, Validation)



to establish unified compliance goals.
• Process Mapping & Automated Workflow Evaluation: Analyze, document, and map multi-modal R&D; workflows (As-Is vs. To-Be); engage with engineering teams to document, understand, and translate the failure modes of automated agentic pipelines into business impact assessments, ensuring business logic and data integrity remain uncompromised.
• Platform & Ecosystem Regulatory Compliance: Evaluate R&D; platforms, software tools, and cloud ecosystems against 21 CFR Part 11 and GxP standards, applying ALCOA+ principles to current and future data lifecycles while conducting gap analyses on internal and third-party software platforms.
• Audit Trail Design & Privacy Standards: Define business requirements for robust, immutable system auditing of user actions and automated model executions; partner with Data Protection Officers (DPOs) to evaluate systems against GDPR and HIPAA mandates, and participate in Data Protection Impact Assessments (DPIAs).
• Impact, Strategy & Complexity: Deliver impact extending to specific products, initiatives, or clusters involving multiple solutions; translate requirements into strategic implementation plans, influence tactical decisions, and contribute to long-term solution roadmaps.



Required Skills & Experience
• Education &

Experience:
Bachelor's degree in Computer Science, Information Technology, Legal Studies, or a related field (Required); 5+ years of Business Analysis / Consultancy experience, with at least 3+ years in life sciences/pharma or the assigned business function (Required).
• Technical & Regulatory

Skills:
Hands-on experience with 21 CFR Part 11, GxP, ALCOA+, GDPR, HIPAA, and EU AI Act, alongside an awareness of Software as a Medical Device (SaMD) (Required).
• BA Toolkit & Frameworks: Advanced knowledge of BA practices with strong proficiency in requirements elicitation, documentation, traceability, and change management; independent application of frameworks like Business Process Modelling (BPMN), SWOT, gap analysis, and risk management (Required).
• Systems, Tools & Data Literacy: Proficiency with Agile Lifecycle Tools (Jira, Confluence, Retina) and Diagramming/Mockup Tools (Visio, Miro, Lucidchart, AI prototyping); comfort navigating complex technical architectures, data models, cloud infrastructure concepts, and audit log structures (Required).
• Core Competencies & Certifications: Exceptional communication, conflict resolution, and consensus-building skills with a systems-thinking mindset and analytical rigor; CBAP certification (or equivalent like IIBA CCBA, Six Sigma Green Belt) is preferred, and a PMP certification is a plus. We positively value all work or study experience abroad. All positions require a high level of English (at least B2)
- please send your detailed CV in English.

📌 Senior GxP (España)
🏢 ALTEN Delivery Centre Spain
📍 España