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