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Novartis

Global pharmaceutical company delivering science-based innovations

Head DDIT ISC Software Development Governance - Integrity & Secure Software Development Life Cycle, Software Development Life Cycle

Security Engineering & Architecture +1Confirmed live in the last 24 hours
Full-timePrague, Czechia

About the Job

Requirements

  • Substantial hands-on software engineering experience, including writing production code, owning continuous integration and continuous delivery pipelines, and currently reading and modifying pipeline configuration, infrastructure as code, and policy code without assistance; candidates should expect a technical assessment.
  • At least 10 years of experience in software engineering, platform engineering, DevSecOps, or engineering quality, including senior technical ownership of delivery pipelines at scale.
  • Experience designing and operating automated controls in regulated environments, including replacing manual compliance work with software.
  • Working fluency in regulated-software requirements relevant to pharmaceuticals and life sciences, including GxP, GAMP 5 (2nd Edition), Computer Software Assurance, 21 CFR Part 11, EU Annex 11, and data integrity/ALCOA+.
  • Security engineering depth in application security, software supply-chain security, secrets and identity management, and vulnerability management.
  • Credible technical judgment on AI in the software development lifecycle, covering both tooling and governance implications.
  • Ability to influence across engineering, quality, and business lines without authority, and to hold positions with senior stakeholders and auditors.
  • Excellent written English.

Responsibilities

  • Own enterprise policy, standards, and controls for software engineering, including source control, branching, peer review, testing, release management, environment segregation, change control, configuration, and release documentation.
  • Rationalize overlapping GxP, SOX, privacy, security, and IT-quality requirements into one coherent, risk-based framework, ensuring low-risk internal tools are not governed like regulated clinical systems.
  • Retire SDLC controls that do not reduce risk and ensure tooling is implemented to securely accelerate software development at enterprise scale, leveraging 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 define control telemetry, including coverage, exceptions, drift, mean time to remediate, and control effectiveness, with a focus on agility, automation, and speed.
  • Own secure-by-default guardrails in golden pipelines and paved-road platforms, aligning with recognized frameworks including NIST SSDF, ISO/IEC 27001, and IEC 62304 where applicable.
  • Define controls for AI-assisted engineering, including acceptable use of coding assistants and agentic tooling, intellectual property and licence exposure, provenance, attribution, and human accountability for review and approval.
  • Define controls for AI-containing products, including model lifecycle, dataset and model documentation, evaluation, drift monitoring, explainability, human oversight, and readiness for evolving regulatory requirements.
  • Use AI to reduce compliance burden through automated risk-assessment drafting, control mapping, test generation, deviation triage, and documentation synthesis, while serving as technical authority for inspections, audits, certifications, and SDLC remediation.
  • Lead a federated community of engineering, quality, security, and compliance practitioners; publish practical guidance; advise senior leaders on risk and trade-offs; and partner with software developers across the enterprise to enable efficient delivery of compliant and secure products.

Desired Qualifications

  • Experience in pharmaceuticals, biotechnology, medical devices, or another regulated industry such as finance, aviation, or nuclear, with actual inspection or audit exposure.
  • Experience with SOX ITGC in engineering contexts, IEC 62304/software as a medical device, and privacy by design under GDPR.
  • Hands-on experience with modern technology stacks, including Git-based platforms and policy/protection features, container orchestration, cloud, infrastructure as code, policy engines such as OPA/Rego or equivalent, test automation frameworks, software bills of materials, and signing tools.

About the Company

Novartis

Global pharmaceutical company delivering science-based innovations

Novartis is a global pharmaceutical company that uses science-based innovations to develop treatments and improve patient outcomes worldwide. Its products are medicines developed through research and development to address various diseases, aiming to reach nearly 1 billion people. The company differentiates itself by large-scale investment in R&D, a global presence with a diverse workforce, and a clear mission to Reimagine Medicine, focusing on meeting the changing needs of patients. Its goal is to improve quality of life and extend life expectancy by delivering meaningful therapies through its research and development efforts.

Company size
10,001+
Company stage
IPO
Headquarters
Basel, Switzerland
Founded
1970

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