Operations IT Delivery Lead

About the role - Location Tarzana, CA 

The Operations IT Delivery Lead (Contract/Consultant) partners with Cell Therapy Manufacturing and QC at our client s Tarzana and Santa Monica sites to deliver digital capabilities that enable reliable, compliant, and scalable operations. This role blends business analysis, project management, and stakeholder representation. You will translate operational needs into IT solutions, lead delivery across key initiatives, and represent the team in site forums and governance.

Key responsibilities

• Business analysis: Elicit and document requirements, process maps, and user stories for manufacturing and QC workflows; define nonfunctional requirements and acceptance criteria; maintain traceability.
• Project management: Plan and execute projects (scope, schedule, budget, risks, issues, dependencies); run agile or hybrid delivery; coordinate resources across IT, vendors, and site functions; manage change control.
• Stakeholder engagement: Represent Ops IT in stakeholder meetings and SLT forums; align expectations, communicate plans/impacts, and facilitate decisions; prepare concise updates and risk/mitigation summaries.
• Navigate IT processes and assessments: Lead and coordinate required processes end-to-end (Information Security, Privacy, Architecture Review, ThirdParty Risk, GxP/validation, data protection, and change/release management). Ensure timely submissions, evidence collection, and approvals; proactively manage audit readiness and remediation.
• Compliance and validation: Ensure alignment with GxP, data integrity, 21 CFR Part 11 (where applicable), and standards.
• Continuous improvement: Capture feedback, prioritize enhancements, and implement changes through controlled releases; champion process-led, configuration-first design principles.

Required qualifications

• Bachelor s degree in Information Technology, Engineering, Life Sciences, or related field; or equivalent experience.
• 5+ years of experience in operations, validation, or IT/business project delivery within large pharma or biotech organizations (e.g., manufacturing, QC, or laboratory settings).
• Demonstrated ability to translate complex operational workflows into clear requirements and deliverables; strong documentation and communication skills.
• Track record delivering cross-functional projects with vendors and internal teams; proficiency with agile/hybrid methods and tools.
• Familiarity with GxP, data integrity (ALCOA+), validation (GAMP5), and 21 CFR Part 11.
• Strong stakeholder management, influencing, and meeting facilitation skills; comfortable representing IT in leadership forums.

Preferred qualifications

• Prior experience navigating IT processes and assessments, or equivalent experience within a large pharma/biotech organization.
• Experience in cell therapy or advanced therapy manufacturing/QC.
• Knowledge of enterprise information security, privacy, and architecture assessment processes.
• Technical literacy in AI, IT systems and networking, OPC UA/instrument protocols, and cloud services (AWS).

Engagement details

• Work arrangement: On-site presence at Tarzana and Santa Monica for workshops, deployment/cut-over support, stakeholder sessions, and validation activities. On-site expectation is 3 days per week minimum.
• Hours: Align to Pacific Time core hours; support off-hours cut-over windows as needed with notice.
• Reporting line: Reports to Director, Ops IT Business Partner Cell Therapy (Tarzana & Santa Monica).