Computer System Validation Manager Jobs in Claymont, DE

The role:

The Director of IT and Business Enablement is a high-impact and highly visible role at a company on the cusp of clinical-stage milestones. This is a hands-on leadership role for someone who operates both as a strategist and a builder.  You will own Dispatch's IT and digital function end-to-end, orchestrating our MSP and a small set of specialist partners rather than staffing a large internal team. You will partner daily with our scientific, clinical, regulatory, quality, and finance leaders to turn their needs into the right technology, and you will be the person accountable when a partner or sponsor examines how we operate.   Travel to our San Francisco office, up to 25% of the time.

Key responsibilities:

Applications Strategy & Business Process Enablement

• Own and maintain a company-wide applications roadmap, balancing near-term needs with a scalable, cost-effective architecture that can grow with the company through clinical development and beyond.
• Lead the evaluation, selection, and deployment of enterprise applications, ensuring thoughtful change management and user adoption and stand up a lightweight technology intake and governance process so that new tools are adopted deliberately rather than in silos.

Data Governance & Security

• Own the organization's information security posture, orchestrating our MSP and specialist providers to maintain a resilient, audit-ready security program.
• Establish and maintain core security foundations: identity and access management (SSO, MFA, and joiner/mover/leaver lifecycle), endpoint protection, and backup and disaster recovery.
• Design and govern data architecture, storage, access controls, and lifecycle management appropriate for a clinical-stage biotech operating under GxP requirements.
• Own data integrity and computer system validation (CSV) for GxP-relevant systems, including 21 CFR Part 11 (electronic records and signatures), ALCOA+ data-integrity principles, and audit-trail review.
• Ensure data generated by lab instrumentation and scientific systems (for example, LIMS and ELN) are captured, secured, and governed under the same controls as the rest of the environment.
• Partner with research leads to understand evolving computational needs and proactively plan capacity and tooling.
• Develop and enforce IT policies and procedures that reflect both regulatory requirements and practical operational realities.
• Serve as the technical owner for partner and sponsor due diligence: complete security and quality questionnaires, support external audits, and maintain the documentation that makes a partner inspection a non-event.

IT Operations

• Serve as the primary internal point of contact for our IT MSP to ensure service quality, accountability, prioritization and continuous improvement.
• Manage relationships with IT vendors and third-party service providers, conducting regular business reviews and driving continuous improvement.
• Develop and manage short- and long-term IT budgets, optimizing spend across MSP services, SaaS applications, cloud infrastructure, and security tools.
• Ensure consistent IT service delivery across our Philadelphia and San Francisco offices.

AI Strategy & Adoption

• Set the AI architecture, data-handling guardrails, and acceptable-use policy, so that functional teams can own their AI adoption within those guardrails.
• Evaluate how AI tools integrate with our existing tech stack and guide the build-out of an AI-compatible data and application architecture.

Required experience & skills: 

• Bachelor's degree
• At least 10 years of IT experience, with at least 3 in a biotech or pharmaceutical environment, ideally at the clinical stage
• Working knowledge of GxP and GCP requirements for electronic systems, including computer system validation (CSV), 21 CFR Part 11, and data integrity (ALCOA+)
• Demonstrated experience managing or overseeing MSPs and third-party IT vendors, including SLA accountability and vendor governance
• Strong knowledge of business applications strategy, including evaluating, deploying, and managing enterprise software (HRIS, ERP, LIMS, quality systems, collaboration tools, etc.)
• Hands-on experience enabling cloud computing environments (AWS and/or Azure) for scientific or technical users, with an emphasis on self-service models and cost governance
• Solid understanding of data governance, data privacy, and information security in a regulated biotech or pharma context
• Working knowledge of AI tools and platforms and how they can be integrated into enterprise business processes; comfort with the evolving AI landscape
• Proven ability to operate as both a strategic thinker and a hands-on operator in a lean, fast-moving environment
• Excellent communication and stakeholder management skills; ability to translate technical concepts for non-technical audiences
• Strong project management and organizational skills; ability to manage multiple priorities simultaneously
• Ability to travel about 25% of the time, typically to our office in San Francisco

Preferred experience & skills: 

• Bachelor's Degree in Computer Science, Information Systems, or a related field
• Experience building or scaling IT capabilities at a company transitioning from research-stage to clinical-stage
• Familiarity with systems supporting clinical trials and regulated workflows (eTMF, CTMS, eQMS, etc.)
• Hands-on involvement with enterprise AI strategy, tool selection, and deployment in a regulated environment
• ITIL certification and/or CISSP or equivalent security credential
• Experience supporting big-pharma partnerships or sponsor audits, including preparing for and response to partner security and quality due diligence