Snr. Solution Analyst – STEP – SAP Quality

Posted 2 Days Ago
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Sandoz, CA, USA
In-Office
Senior level
Biotech • Pharmaceutical
The Role
Lead requirements gathering, design, validation and deployment of SAP batch management and batch release processes for new sites. Produce URS, manage requirements traceability, coordinate integrations (SAP and non-SAP), support UAT and validation, train end users, and provide cutover and post-go-live support while ensuring GxP/CSV compliance.
Summary Generated by Built In

Job Description Summary

Seeking an experienced Solution Analyst responsible for SAP batch management and batch release process deployment to new Sandoz sites including User Requirements Specification development, solution design, validation and overall support. Solution Analyst will act as the primary liaison between business stakeholders and technical teams ensuring requirements complement global template, are complete, aligned with regulatory and operational needs, implemented, tested and deployed.

Job Description

Major accountabilities: 

  • Lead workshops and interviews with end users, QA leadership and operations to capture functional and non-functional requirements for batch management and batch release process.
  • Produce clear, comprehensive User Requirements Specifications (URS) and scope documents tailored to company needs, compliant with internal and regulatory standards (e.g., GxP) and in line with STEP global template and program design principles.
  • Translate business needs into traceable, testable requirements; manage requirements versioning and change control.
  • Collaborate with external IT service providers, solution architects, developers, integrators and validation engineers to ensure requirements are implementable and design decisions are documented.
  • Facilitate design review sessions and walk-throughs with business stakeholders to validate proposed solutions.
  • Ensure technical integration with other SAP and non-SAP systems.
  • Support development of functional specifications, data migrations, use cases, process maps, data mappings and configuration matrices as needed.
  • Coordinate and support User Acceptance Testing (UAT): develop UAT scripts from URS, triage issues and track resolutions.
  • Provide guidance and support to end‑users including training materials or hands‑on sessions when needed.
  • Work with validation/PQM to develop validation plans and ensure requirements coverage in test protocols.
  • Manage stakeholder expectations, communicate project status, risks, and impacts, and escalate issues as needed.
  • Maintain traceability matrices and ensure requirements link through design, test, and deployment artifacts.
  • Contribute to deployment planning, cutover activities, and post-go-live support/lessons learned.

Key performance indicators:

  • Requirements Analysis: Measure the effectiveness of collaborating with business stakeholders to gather and analyze requirements, ensuring they are clearly defined and documented.
  • Solution Design: Track the development of comprehensive solution designs that align with business objectives and leverage different technologies.
  • Implementation Management: Measure the quality, timeliness, and budget adherence of implemented technology solutions.
  • Integration: Evaluate the seamless integration of systems and the resolution of any technical challenges that arise.
  • Stakeholder Engagement: Measure the effectiveness of acting as a liaison between technical teams and business stakeholders, facilitating effective communication and collaboration.
  • Testing and Quality Assurance: Track the development and execution of test plans to ensure solutions meet business requirements and quality standards.
  • Documentation: Measure the completeness and accuracy of documentation for solution designs, implementation plans, and testing results.
  • Training and Support: Evaluate the effectiveness of training and support provided to end-users.
  • Regulatory Compliance: Ensure that all solutions comply with relevant regulatory requirements and industry standards.

Minimum Requirements: 

Education:

  • Bachelor’s degree in Computer Science, Information Technology, Industrial Engineering, Biomedical Engineer, Business Administration, or related field
  • Certification in project management methods (Agile, ITIL, Prince 2, PMI) is a plus.
  • Experience with Agile/DevOps methodologies; Certification is a plus

Work Experience:

  • 5+ years of experience in project delivery and/or application management or IT services within a multinational organization. 
  • Expert knowledge and experience in implementation of SAP Quality management and SAP Batch Release Hub in life science industry and in the operations of those.
  • Experience in sap QM deployments in Pharma Industry
  • GxP and CSV proven methodology knowledge
  • Integration with other systems experience in Pharma Industry (other SAP systems, LIMS, Veeva, etc.) 
  • Good leadership, communication, and collaboration skills.
  • Effective communication and stakeholder management skills, with the ability to explain complex technical concepts to non-technical audiences.
  • Strong analytical and problem-solving skills.
  • Strong leadership and team-building skills
  • Proven ability to work effectively in a fast-paced, dynamic environment and drive change and innovation.
  • Experience in managing global projects and working in diverse cultural environments.
  • Proficiency in using advanced software tools and platforms relevant to the job.
  • Experience with ITIL frameworks and other service management methodologies.

 Skills:

  • Analytical Thinking.
  • Business Acumen.
  • Change Management.
  • Influencing.
  • IT Governance.
  • Organization Development.
  • Planning.
  • Presentation Skills.
  • Servant Leadership.
  • Stakeholder Management.

Languages:

  • English.

Skills Desired

Analytical Thinking, Business Acumen, Change Management, Influencing, IT Governance, Organization Development, Planning, Presentation Skills, Servant Leadership, Stakeholder Management

Skills Required

  • Bachelor's degree in Computer Science, Information Technology, Industrial Engineering, Biomedical Engineering, Business Administration, or related field
  • Certification in project management methods (Agile, ITIL, Prince 2, PMI)
  • Experience with Agile/DevOps methodologies
  • 5+ years of experience in project delivery, application management, or IT services within a multinational organization
  • Expert knowledge and experience implementing SAP Quality Management and SAP Batch Release Hub in the life sciences/pharma industry
  • Experience deploying SAP QM in the pharmaceutical industry
  • Knowledge of GxP and Computer System Validation (CSV) methodologies
  • Experience integrating SAP with other systems (LIMS, Veeva, other SAP systems)
  • Leadership, communication, stakeholder management and collaboration skills
  • Strong analytical and problem-solving skills
  • Experience managing global projects and working across diverse cultural environments
  • Proficiency with relevant advanced software tools and platforms
  • Experience with ITIL frameworks and service management methodologies
  • English language proficiency

Sandoz Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Sandoz and has not been reviewed or approved by Sandoz.

  • Healthcare Strength Health, dental, vision, and prescription coverage are consistently described as core components across U.S. roles and materials. Feedback suggests the medical offering is broad and a standard pillar of the package.
  • Retirement Support A 401(k) plan with a company match described as generous is commonly included for U.S. roles. This savings support is positioned alongside other primary benefits as part of total rewards.
  • Equity Value & Accessibility Equity eligibility is noted for many positions and a global all‑employee share program is being introduced from 2026. These elements add upside beyond base salary and annual bonus.

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The Company
HQ: Basel
17,135 Employees

What We Do

Sandoz is the global leader in generic and biosimilar medicines. ​ ​Our Purpose is to pioneer access to medicines for patients globally. We are on a mission to drive innovation in the healthcare industry by freeing up resources sustainably and responsibly while continuing to address global health challenges such as antimicrobial resistance.​ We are present in more than 100 countries and our medicines serve some 500 million people every year. We have two main global businesses: Generics - divided between standard generics and complex generics - and Biosimilars.

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