Enterprise Architect

Must Have

• Key Responsibilities • Define and maintain the enterprise architecture vision and roadmap aligned with pharma business goals (R&D, clinical, manufacturing, supply chain) • Ensure compliance with global regulations including GxP, FDA 21 CFR Part 11, and Annex 11 • Drive digital transformation initiatives (e.g., lab digitization, smart manufacturing, real-world evidence platforms) • Define enterprise data strategy ensuring data integrity (ALCOA+), governance, and traceability • Standardize platforms across functions (e.g., LIMS, ERP, MES, Clinical systems) • Partner with business and quality leadership to align IT investments with regulatory and operational priorities • Establish architecture governance, validation strategy, and risk management frameworks • Evaluate and adopt emerging technologies (AI/ML in drug discovery, IoT in manufacturing, cloud for clinical data) • Enable interoperability across systems using standardized integration patterns and APIs • Translate business and regulatory requirements into validated solution architectures • Ensure all systems are developed and maintained in compliance • Support implementation teams with architecture guidance and validation documentation • Conduct architecture reviews, risk assessments, and impact analysis for system changes • Oversee system integration ensuring traceability and compliance across data flows • Collaborate with QA and regulatory teams during audits and inspections • Resolve complex technical and compliance-related challenges during delivery
• Key Skills & Competencies • Strong knowledge of pharma regulatory frameworks and compliance requirements • Expertise in enterprise architecture frameworks (e.g., TOGAF) • Experience with pharma systems • Deep understanding of data integrity, validation, and quality systems • Ability to balance innovation with compliance constraints
• Qualifications • 12+ years of IT experience, with 3–5 years in enterprise/solution architecture • Proven experience in pharmaceutical, life sciences, or regulated industries • Certifications: TOGAF, cloud (AWS/Azure), or pharma compliance certifications preferred • Familiarity with AI/ML use cases in drug discovery or manufacturing
• Key Outcomes • Fully compliant and audit-ready IT landscape • Reduced compliance risks and successful regulatory inspections • Standardized and validated system architecture across functions • Improved data integrity, traceability, and reporting accuracy

EQUAL OPPORTUNITY