1 job for "Sr. Principal, IT Quality and Compliance"

Director, I&T Plasma Engineering

At CSL - King of Prussia

Posted on Oct 16

Director, I&T Plasma Engineering

King of Prussia, PAPosted 24 days ago

The Director, I&T Plasma Engineering leads engineering and owns architecture governance across all CSL Plasma digital product domains. This role is internally focused on how the organization builds. Defining and owning the engineering standards, practices, and technology platform strategy that all development teams, managed service providers, and external vendors are held to. This role is also responsible for governing Artificial Intelligence (AI) and Generative AI in production across CSL Plasma. This spans AI features inside donor-facing and operational products, AI-assisted software development inside the engineering team, and the operational discipline required to run AI reliably at scale.

The Director, I&T Plasma Engineering is distinct from product delivery coordination (owned by the Delivery Manager) and product strategy (owned by Sr. Directors and Product Owners). This role owns the technical foundation: the quality bar, the architectural patterns, the cross-cutting engineering capabilities, and the security and compliance posture that make reliable, scalable digital product delivery possible.

This is a technical leadership role. The Director stays close enough to the work to be credible with the engineers doing it, contributes personally where judgment is required, and delegates confidently everywhere else.

This position reports to: Senior Director, Plasma I&T Applications & Operations
Reporting to this position: Plasma Business Architect, AI/ML Product Engineer, Automation Engineer, Data Engineer, SRE/DevOps Engineer, UX Designers
Principal Accountabilities

1. Engineering Standards & Practices

•Own and define the 'how we build' standards across all five Plasma digital product domains: coding standards, testing standards, security standards (in formal matrix partnership with the CSL Cyber organization), DevOps and CI/CD practices, and architectural patterns.

•Set the technical quality bar that all internal delivery teams, managed service providers, and to which external vendors are contractually and operationally held.

•Enforce standards primarily through the shared engineering platform, automated quality gates, and review of significant technical designs. Architecture review boards are reserved for genuinely novel decisions, not routine sign-off.

•Reviews and approves significant technical designs personally, particularly those setting patterns others will follow.

2. Architecture Governance

•Set and enforce integration standards, data architecture, and cross-product technical decisions across the full Plasma digital ecosystem.

•Serve as the formal interface with the CSL Enterprise Architecture organization. Establish and maintain the cadence with the CSL Enterprise Architecture team, represent Plasma architecture upward, and bring enterprise decisions back to the Plasma team. Approve significant architectural decisions personally; delegate routine architecture work to domain technical leads with clear guardrails.

•Manage and develop the Plasma Business Architect, who executes day-to-day architecture work, alignment reviews, and architecture documentation.

•Owns the target-state architecture for the Data Backbone as an early priority given its role as the foundation for the AI, analytics, and operational data roadmap.

3. Cross-Domain Team Leadership

•Provide direct people leadership for cross-domain enabling functions: Plasma Business Architect, QA Lead, QA Automation Engineers, AI/ML Product Engineer, Automation Engineer, Data Engineer, SRE/DevOps Engineer, and UX Designers.

•Own hiring standards, role design, career development frameworks, and succession planning for the cross-domain engineering team.

•Set and hold a culture of technical excellence, accountability, psychological safety, and continuous learning across the engineering organization.

•Given the transformation of Plasma IT, personally interviews technical leads across the broader net-new hires, not only direct reports, to hold the hiring bar across the Plasma technology team.

4. Technology Platform Strategy

•Own the engineering tooling, platform, and capability roadmap - including the Data Backbone architecture, Middleware integration standards, cloud infrastructure direction, and the DevOps toolchain - in conjunction with enterprise capability owners.

•Ensure the technology platform evolves in step with the Plasma product roadmap, anticipating capability needs 12-24 months ahead.

•Evaluate build vs. buy vs. partner decisions for platform capabilities; provide technology investment recommendations to senior leadership.

•Owns the shared engineering platform that every Plasma product team builds on. This covers service templates, CI/CD pipelines, deployment patterns, observability, and security guardrails, delivered as a coherent product with a roadmap, an internal customer base across the domains, and adoption as the measure of success. The platform team builds it; the Director sets direction, approves the platform architecture, and reviews the highest-risk design decisions personally.

5. Technical Quality Oversight

•Review and approve technical approaches for significant architectural decisions across all Plasma digital products and vendor solutions.

•Serve as the escalation authority for technical quality issues that cannot be resolved within individual product delivery teams.

•Establish metrics for technical health: code quality, test coverage, lead time for changes, deployment frequency, change failure rate, and mean time to recovery (MTTR). Complement these delivery metrics with developer experience measures such as onboarding time, environment setup time, and developer satisfaction.

•Update engineering quality gates as AI coding assistants generate an increasing share of code, so that review depth, test coverage, and traceability scale with the change in how code is produced,

6. Artificial Intelligence Strategy & Governance

•Establish and execute an AI/Generative AI strategy for the engineering organization, identifying opportunities to apply AI technologies to accelerate delivery, improve quality, and enable new business capabilities.

•Drive the adoption of AI-assisted software development practices, including code generation, testing automation, documentation generation, and developer productivity tooling.

•Partner with business stakeholders, data teams, enterprise architecture, and security teams to identify, prioritize, and deliver AI-enabled solutions.

•Ensure AI solutions are developed and deployed in accordance with enterprise governance, regulatory, privacy, data protection, and responsible AI standards.

•Own the operational discipline for AI in production across CSL Plasma. This can includes model evaluation and evaluation harnesses, model observability and monitoring, prompt and version management, guardrail patterns and red-teaming, and cost management for inference and GPU spend. Established once as a shared capability and reused across deployed and planned Plasma AI products as well as subsequent AI use cases as the ecosystem matures.

7. Security & Compliance Standards

•Establish and own the formal matrix relationship with the CSL Cyber team for security and compliance standards across Plasma digital products.

•Ensure healthcare data protection, GDPR, and cloud security posture requirements are embedded in engineering standards - not treated as a separate audit activity.

•Oversee regulatory compliance engineering for applicable frameworks: 21 CFR Part 11, HIPAA, GxP, and EU Annex 11.

•Security controls are embedded in the shared engineering platform so that regulated defaults apply to every new service by construction, rather than being layered on at the end.

Required Skills & Experience

•Bachelor's degree in Computer Science, Software Engineering, or related field; Master's degree preferred.•10+ years of progressive software engineering experience with at least 5 years in engineering leadership roles.

•Demonstrated success building and leading cross-functional engineering teams across multiple technical domains.

•Recent - within the last three years -- hands-on engineering. This role is a hands-on-enough-to-be-credible technical leader, not a pure people manager.

•Track record of setting engineering standards, patterns, and paved paths that were adopted across multiple product teams, not documented and shelved.

•Track record of shipping production AI systems, not pilots. Includes evaluation, observability, guardrails, and cost management for AI in production.

•Product engineering depth across native mobile, full-stack web, Salesforce platform, and API and integration development. Credible with the engineers building those products.

•Deep expertise in enterprise architecture, integration platforms (MuleSoft, AWS, Azure), and cloud-native technology strategy.

•Demonstrated experience implementing, integrating, or leading initiatives involving Artificial Intelligence (AI), Machine Learning (ML), and/or Generative AI technologies in an enterprise environment.

•Strong understanding of modern AI platforms, Large Language Models (LLMs), retrieval-augmented generation (RAG), AI evaluation, guardrails, and lifecycle management (evaluation harnesses, tracing, red-teaming), agentic workflow patterns, and related cloud-native AI services.

•Strong experience establishing engineering governance: coding standards, architecture review processes, CI/CD pipelines, and technical quality metrics.

•Proven ability to define and enforce security and compliance engineering standards in partnership with Cyber and Legal organizations.

•Experience managing and developing senior technical staff including architects, QA leads, and specialist engineers.

•Excellent executive communication skills; able to translate technical strategy into business language for senior leadership.

•Experience shipping software in a regulated or consumer-scale environment. Regulated industries include life sciences, healthcare, financial services, and other environments where controls, audit trails, and validation are part of engineering practice. Consumer-scale environments include retail, fintech, media, travel, and other settings where reliability and user experience have direct business consequence. Comfort working inside regulated context, including a willingness to build working knowledge of 21 CFR Part 11, HIPAA, GxP, and EU Annex 11 as they apply to the role. Experience with life sciences, healthcare, or pharmaceutical industry engineering standards preferred.

Preferred Skills & Experience

•Prior life sciences, healthcare, or pharmaceutical industry experience, or prior direct experience with 21 CFR Part 11, HIPAA, GxP, or EU Annex 11.

•Knowledge of MuleSoft Anypoint Platform, Informatica IDMC, and AWS/Azure enterprise integration patterns.

•Experience managing managed service providers and offshore engineering teams.

•AWS Solutions Architect (Professional), Certified Kubernetes Administrator, HashiCorp certifications, or equivalent architecture or platform-engineering credentials.

•Technically Credible. Stays close enough to the code and the architecture to earn the respect of the engineers doing the work. Contributes personally where judgment is required and delegates confidently everywhere else.

Competencies

•Architectural Vision - shapes a technology platform strategy that enables scalable, secure, and sustainable product delivery.

•Standards Leadership - builds a culture where engineering quality standards are understood, respected, and consistently met.

•Talent Developer - recruits, develops, and retains high-caliber engineers and architects across disciplines.

•AI & Digital Innovation Mindset - evaluates emerging technologies and identifies practical opportunities to leverage AI and intelligent automation to create business value.

•Responsible Technology Leadership - balances innovation with governance, ensuring AI capabilities are implemented in a secure, compliant, ethical, and sustainable manner.

•Trusted Advisor - earns the confidence of product leadership, business stakeholders, and the CSL enterprise architecture community.

•Governance with Judgment - applies standards with rigor while remaining pragmatic about delivery realities and trade-offs.

•Security Champion - ensures compliance and data protection are embedded in engineering DNA, not bolted on at the end.

About CSL Behring

CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients' needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.

CSL Behring operates one of the world's largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.

To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/.

Our Benefits

For more information on CSL benefits visit How CSL Supports Your Well-being | CSL.

You Belong at CSL

At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.

To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging

Equal Opportunity Employer

CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement.

About CSL

CSL is a leading global biotechnology company with a dynamic portfolio of lifesaving medicines and therapies

Size: 10,000+ employees
Industry: Biotechnology

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