Sr Manager, IT Business Analysis

Role Summary

Senior Manager, IT Business Analysis leads the primary IT Business Analysis partnership for La Verne Manufacturing, Global Quality, and PSO. The role translates business needs into technology strategies, roadmaps, and solution requirements, and identifies process improvements to enhance compliance, efficiency, and operational execution. You will provide structure, clarity, and decision support in ambiguous environments and deliver compliant, scalable solutions, including AI-enabled initiatives within GxP environments. This role requires collaboration across global, cross-functional teams and a focus on delivering value in regulated manufacturing environments.

Responsibilities

• Business Partnership
  • Serve as the primary IT Business Analysis partner for La Verne Manufacturing, Global Quality, and PSO.
  • Translate business needs into clear, actionable technology strategies, roadmaps, and solution requirements.
  • Identify and drive process improvements that enhance compliance, efficiency, and operational execution.
  • Provide structure, clarity, and decision support in ambiguous or evolving business environments.
• Digital & AI Enablement
  • Drive AI literacy and adoption across manufacturing, quality, and PSO organizations.
  • Assess, shape, and support delivery of AI-enabled use cases aligned with GxP and responsible AI standards.
  • Support change management, adoption, and readiness for new digital workflows and tools.
• Systems & Operational Support
  • Provide business analysis and enhancement support for MES, SAP, automation interfaces, Veeva QMS, GMax, and other regulated GxP systems.
  • Partner with business teams on deviations/CAPA, audit readiness, lifecycle quality, and operational readiness processes.
  • Ensure all system updates and changes comply with GxP, 21 CFR Part 11, and Good Documentation Practices (GDP).
• Delivery & Continuous Improvement
  • Lead requirements gathering, process mapping, validation planning, and User Acceptance Testing (UAT) activities.
  • Collaborate with project managers, solution architects, and vendors to deliver stable, compliant, and scalable solutions.
  • Support issue resolution and drive continuous improvement initiatives across systems and processes.
  • Benchmark site capabilities and contribute to cross-site harmonization and global standards.
• Stakeholder Engagement
  • Build and maintain trusted partnerships with site and global business leaders.
  • Clearly communicate risks, insights, trade-offs, and recommendations to diverse stakeholders.
  • Provide informal leadership and mentorship to analysts and cross-functional partners.

Qualifications

• Required: BS with at least 8 years of experience in IT, business analysis, or operations.
• Required: MS with at least 6 years of experience in IT, business analysis, or operations.
• Required: Experience supporting sterile manufacturing, biologics, or regulated GxP environments.
• Required: Strong judgment, prioritization skills, and ability to work effectively through ambiguity.
• Required: Hands-on experience with MES, SAP, QMS, automation systems, and integrated manufacturing platforms.
• Required: Strong AI literacy, including copilots, agentic AI concepts, and data-driven workflows.
• Required: Excellent communication and collaboration skills in global, matrixed organizations.
• Preferred: Experience supporting global manufacturing, quality, or supply chain operations.
• Preferred: Skills in process modeling, business case development, and technology evaluation.
• Preferred: Understanding of biologics manufacturing operations and global quality systems.
• Preferred: Experience delivering digital transformation initiatives or AI-enabled solutions in regulated environments.

Skills

• Strong business acumen and operational awareness.
• Deep understanding of GxP systems, digital platforms, and AI enablement.
• Collaboration and influencing skills across global, cross-functional teams.
• Ownership, accountability, and disciplined execution.
• High-quality decision-making and professional judgment.
• Learning agility and adaptability in a fast-changing environment.
• Clear, concise, and effective communication.