Business Analyst

About the Role of Business Analyst

As a Business Analyst, you will be instrumental in developing and implementing validation strategies for critical systems like Spark Integration, including the QMS Replacement (Veeva Spark to Veeva Roche). This role ensures strict adherence to regulatory requirements, industry best practices, and Roche internal standards.

Key Responsibilities

• Develop and implement a validation strategy for Spark Integration, encompassing QMS Replacement (Veeva Spark to Veeva Roche), ensuring alignment with regulatory requirements, industry best practices, and Roche internal standards.
• Create comprehensive validation plans and protocols for digital solutions, including data pipelines, interfaces, automation applications, data-driven models, and statistical tools, ensuring all validation activities are thoroughly documented and executed according to established procedures.
• Conduct thorough risk assessments to identify potential risks associated with digital solutions in a GMP environment, developing effective risk mitigation strategies and ensuring appropriate controls are in place.
• Oversee testing and qualification activities for digital solutions, particularly with QA SMEs, ensuring alignment with Roche standards, execution of test cases, analysis of results, and documentation of findings.
• Ensure all validation activities comply with relevant regulatory requirements, such as GMP and data integrity guidelines, maintaining accurate and up-to-date validation documentation including plans, protocols, reports, and change control documentation.
• Collaborate effectively with IT Business Partners, Stakeholders, Product Owners, and the Development Team (Testers, Developers, IT Architects, Adoption Services, and external Vendors).
• Strive for harmonization of business processes across sites and departments by propagating common standardized data models, applications, and technologies in line with cross-functional or Informatics strategies and architectures.
• Explore opportunities for professional growth and take on additional roles, such as squad leads, as appropriate.
• Demonstrate strong business partnering and/or product management skills.
• Perform detail-oriented work with a high degree of accuracy and explain complex concepts clearly and simply.
• Demonstrate knowledge of current GxP requirements and documentation standards, with the ability to write validation documents.
• Manage communications with multiple business units and internal IT cross-functional teams.
• Ensure delivery aligns with the Spark Integration Project.

Candidate Requirements

• Solid understanding of software development lifecycle models and experience with business/end-user applications.
• Strong knowledge of validation principles and practices in a GMP environment, with experience in validating digital solutions, Release Management processes, controls, and familiarity with test automation.
• Prior experience with business/end-user applications, especially patient access or physician portals, is a plus.
• Project-based work experience in the pharmaceutical industry.
• Experience with implementing Technical Operations System and Equipment.
• Familiarity with Manufacturing, Quality, intercompany order processing, and outbound logistics processes.
• Proactively seek improvements in ways of working (process, tools, organization) and work independently.
• Ability to understand technical processes, with strong communication skills to train and coach others.
• Excellent communication skills, fluent in written and spoken English.
• Ability to travel up to 10% as needed.

Key skills/competency

• Validation Strategy
• GMP Compliance
• GxP Requirements
• Risk Assessment
• Digital Solutions Validation
• Documentation Standards
• Spark Integration
• Veeva QMS
• SDLC
• Stakeholder Collaboration