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Head DDIT ISC - Software Development Governance & Secure SDLC

novartis · Barcelona Gran Vía

New
Hybrid Senior 92,600 - 172,000 EUR/year 🇬🇧 English
CI/CD IaC OPA/Rego GxP GAMP 5 21 CFR Part 11 ISO/IEC 27001 IEC 62304 NIST SSDF SBOM Git

Job description

About the role

Novartis is looking for a Head of DDIT ISC to own the enterprise SDLC governance model and build much of it: policy as code, automated evidence capture, pipeline controls and reference architectures. The role is hands-on and individual-contributor leadership: it sets enterprise direction and influences hundreds of engineers through a federated community, without a large direct team, and includes meaningful time in repositories, pipelines and control code. It is a hybrid position in Barcelona.

Key responsibilities

  • Own the enterprise policy, standards and controls for software engineering, covering source control, branching, peer review, testing, release management, environment segregation, change control and documentation.
  • Rationalise overlapping GxP, SOX, privacy, security and IT-quality requirements into one risk-based framework, so low-risk internal tools are not governed like regulated clinical systems.
  • Retire SDLC controls that do not reduce risk and implement tooling that speeds up secure software development at scale, using and creating AI tooling.
  • Implement policy-as-code and controls-as-code, including branch protections, mandatory review, signed commits, segregation of duties, deployment approvals and immutable audit trails.
  • Build automated, continuous evidence pipelines and control telemetry (coverage, exceptions, drift, MTTR, effectiveness).
  • Define secure-by-default guardrails in golden pipelines and paved-road platforms, aligned with NIST SSDF, ISO/IEC 27001 and IEC 62304 where applicable.
  • Define controls for AI-assisted engineering and AI-containing products, including acceptable use, IP and licence exposure, provenance, attribution and human accountability.
  • Use AI to reduce compliance burden (risk assessment drafting, control mapping, test generation, deviation triage, documentation synthesis) and act as technical authority for inspections, audits and certifications.
  • Lead a federated community of engineering, quality, security and compliance practitioners, publish guidance and advise senior leaders.

Required profile

  • Substantial hands-on software engineering experience: writing production code, owning CI/CD pipelines, reading and modifying pipeline configuration, IaC and policy code.
  • 10+ years in software engineering, platform engineering, DevSecOps or engineering quality, with senior technical ownership of delivery pipelines at scale.
  • Experience designing automated controls in regulated environments, with evidence of replacing manual compliance work with software.
  • Fluent knowledge of regulated-software requirements in pharma/life sciences: GxP, GAMP 5 (2nd Ed.), CSA, 21 CFR Part 11, EU Annex 11, data integrity and ALCOA+.
  • Security depth: application security, software supply chain security, secrets and identity management, vulnerability management.
  • Credible judgement on AI in the SDLC and ability to influence without authority across engineering, quality and business lines.
  • Excellent written English.

Required skills

  • Git-based platforms and policy/protection features, container orchestration, cloud, IaC, policy engines (e.g. OPA/Rego or equivalent), test automation frameworks, SBOM and signing tooling.
  • Desirable: pharma, biotech, medical devices or other regulated industry experience with inspection or audit exposure; SOX ITGC, IEC 62304 / SaMD, privacy-by-design under GDPR.

What we offer

  • Base salary range of 92,600 to 172,000 EUR, with a possible performance-based bonus.
  • Flexible and hybrid working options where possible, and at least 14 weeks of paid parental leave.
  • Insurance plans, retirement plans, wellbeing resources and global recognition programs.

Questions fréquentes

Le salaire proposé pour ce poste est de 93-172k EUR par an. Le détail figure dans l'annonce.
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Published 12 hours ago

Expires 1 month from now

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novartis

Barcelona Gran Vía