Manager, IT Business Analysis

Role Summary

Manager, IT Business Analysis at Gilead. Lead and habilitate IT business analysis activities, collaborating with manufacturing IT and business stakeholders to optimize MES/IT solutions and ensure alignment with GMP/compliance requirements. Onsite role based in La Verne, CA with 24/7 manufacturing support expectations.

Responsibilities

• Lead and mentor IT business analysis activities related to MES solutions and associated manufacturing IT processes.
• Collaborate with IT, production, and engineering teams to implement MES solutions that improve functionality and user experience.
• Engage with functional stakeholders to support business operations and provide technical feedback and effort estimates for MES system requests.
• Plan and oversee system upgrades, patches, and enhancements; conduct training and maintain documentation of configurations and procedures.
• Ensure MES (PAS-X) compliance with industry standards and regulatory requirements; participate in validation activities (IQ/OQ/PQ) and maintain audit trails.
• Provide on-site and on-call support, perform root cause analysis for MES incidents, and implement corrective actions.
• Assess and implement opportunities for AI, ML, and automation integration within manufacturing IT.

Qualifications

• Required: Bachelor’s degree in IT, Computer Science, Engineering, or Pharmaceutical Manufacturing with at least 6 years of MES experience (or Master’s with at least 4 years); preferably with Körber PAS-X; strong understanding of pharmaceutical manufacturing processes and MES lifecycle.
• Required: Experience with SAP-MES integration and Level 2 automation; familiarity with ISA-95/S88; ITIL frameworks; excellent communication and stakeholder engagement skills; ability to work independently and in a 24/7 environment; shift rotation and on-call availability.
• Preferred: Experience with PAS-X MES software and workflow configuration; knowledge of AI/ML in manufacturing; certifications in IT, MES, or automation; GMP and 21 CFR Part 11 familiarity.

Skills

• MES system management (PAS-X) and SAP integration
• Manufacturing processes and GMP/regulatory compliance
• Relationship management with stakeholders
• Technical design and documentation
• AI/ML and automation in manufacturing contexts

Education

• bachelor’s degree in IT, Computer Science, Engineering, or Pharmaceutical Manufacturing; or Master’s degree as specified in qualifications

Additional Requirements

• On-site role in La Verne, California; 24/7 manufacturing support and on-call expectations