We are seeking an experienced Technical Business Analyst with experience. The successful candidate will act as a bridge between business stakeholders, IT, and Quality Assurance teams to ensure explicit requirements gathering, technical documentation, and compliance with regulatory standards.
Key Responsibilities
- Elicit, analyze, document, and manage business and technical requirements including User Requirement Specifications (URS) and Functional Requirement Specifications (FRS).
- Review and interpret technical artefacts such as code snippets, workflows or pseudocode to align business needs with technical solutions.
- Collaborate closely with cross-functional teams including IT, Quality Assurance, and business units to clarify requirements, address gaps, and facilitate smooth solution delivery.
- Ensure compliance with pharmaceutical regulations and standards including Good Practice (GxP) and Computer System Validation (CSV) processes.
- Support testing activities including test case development, execution, defect triage, and validation documentation.
- Utilize project management and requirement tracking tools such as ALM and JIRA to manage requirement lifecycle and maintain traceability.
- Identify and recommend opportunities for process improvements and support strategic technology initiatives, including AI integration where applicable.
- Facilitate workshops and stakeholder meetings to gather requirements and resolve issues proactively.
- Manage controlled documentation updates to ensure alignment with compliance and audit readiness.
Required Skills & Qualifications
- Minimum 6 years’ experience as a Business Analyst in the pharmaceutical or life sciences industry.
- Strong understanding of GxP regulations and Computer System Validation (CSV) in pharmaceutical environments.
- Experience with Veeva Vault systems and/or other regulated content management platforms.
- Proficient in requirements documentation (URS, FRS) and validation documentation practices.
- Technical aptitude – ability to read and analyze code snippets (.NET or pseudocode) is a plus.
- Experience using ALM, JIRA or similar tools for requirement management and project tracking.
- Excellent communication and stakeholder management skills to interact effectively with technical and business teams.
- Detail-oriented with strong analytical and problem-solving skills.
- Ability to work concurrently on multiple initiatives (part-time allocation per project).
Preferred Qualifications
- Exposure to Quality Assurance and regulatory compliance teams within pharma.
- Familiarity with AI or automation technology implementations.
- Experience supporting data archival, decommissioning, or reporting compliance projects.