SAP PLM & Quality IT Director — Regulatory-to-Release

Gilead Sciences Inc.; Maryland; On-site; USD 226,000 - 293,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Stock-based incentives

Discretionary bonus

Paid time off

Job summary

Gilead Sciences Inc. is seeking a senior IT leader to own the Regulatory-to-Release portfolio across PLM, QM, Batch Release, and related digital platforms.

You will partner with Product Development, Regulatory, Quality, Manufacturing, and other functions to set roadmaps and investment priorities, driving standardized, compliant solutions. The role requires 15+ years in SAP/ERP and related delivery, with strong leadership, governance, and executive communication skills to realize measurable

Qualifications

• 15+ years of SAP, ERP, digital platform, product management, solution architecture, or enterprise delivery experience in life sciences or regulated manufacturing.
• Deep experience with SAP PLM, SAP QM, SAP S/4HANA, and regulated product lifecycle, quality, and release processes.
• Strong knowledge of PLM and quality capabilities, including specifications, recipes, BOMs, change management, inspection, batch management, release, genealogy, and related integrations.
• Solid understanding of GxP, GMP, FDA 21 CFR Part 11, validation, data integrity, audit readiness, and regulated delivery practices.

Responsibilities

• Own end-to-end Regulatory-to-Release capability strategy across PLM, QM, Batch Release, and digital platforms.
• Lead delivery across PLM, QM, Batch Release, and related initiatives with compliance and business alignment.
• Oversee cross-functional teams, vendors, and AMS partners to resolve issues and drive integrated planning.
• Govern backlog priorities, release plans, testing, validation, deployment readiness, and hypercare.
• Communicate priorities, risks, progress, and outcomes to senior leadership.

Skills

SAP

ERP

Product management

Solution architecture

Regulated manufacturing

GxP

Executive communication

Governance

Leadership

Delivery management

Education

Bachelor's or Master's degree in IT/Engineering/CS

Tools

SAP PLM

SAP QM

SAP S/4HANA

Job description

Gilead Sciences Inc. is seeking a senior IT leader to own the Regulatory-to-Release portfolio across PLM, QM, Batch Release, and related digital platforms.

You will partner with Product Development, Regulatory, Quality, Manufacturing, and other functions to set roadmaps and investment priorities, driving standardized, compliant solutions. The role requires 15+ years in SAP/ERP and related delivery, with strong leadership, governance, and executive communication skills to realize measurable