Quality Docs Business Analyst

Veeva QualityDocs configuration experience, BA, and validation experience. This role will focus on requirement gathering, documentation, and analysis activities, working closely with stakeholders and the Veeva Project Manager. The resource will ensure that business needs are accurately captured, processes are assessed, and Veeva best practices are applied in the design and delivery of solutions

Key Responsibilities:

•Engage with business users, Quality, IT, and validation teams to capture and refine requirements.

•Document user stories, functional specifications, and configuration needs in alignment with regulatory and compliance standards.

•Act as a bridge between business teams and technical resources to ensure clarity of requirements.

•Partner with the Validation team to support the development of Regulatory Applicability Assessments (RAA) and Regulatory Risk Assessments (RRA).

•Create and maintain functional specifications, user stories, and system configuration documents.

•Conduct technical feasibility assessments for new business requirements and proposed changes.

•Oversee Veeva environment management, including sandbox and production system updates, user provisioning, and access controls.

•Design and implement custom solutions and integrations to automate workflows, enhance platform capabilities, and ensure compatibility with third-party systems.

Preferred Skills:

•Proven ability to support DevOps lifecycle projects.

•Prior experience working in regulated industries such as pharmaceuticals, biotechnology, or life sciences.

•Familiarity with Agile, Waterfall, or hybrid project management methodologies.

•Strong analytical, problem-solving, and communication skills.

•Experience with workflow automation and system integration using APIs.

•Strong communication and analytical skills.