Nature and Scope The Business Systems Analyst II (BSA-II) serves as a liaison between business stakeholders and information technology, translating business needs into system requirements and ensuring technology solutions support operational, regulatory, and quality objectives. This role supports the implementation, validation, and lifecycle management of GxP‑regulated computerized systems within a regulated pharmaceutical environment. The BSA-II will ensure adherence to industry standards and regulations pertaining to CSV, data integrity as well as all internal quality system requirements.
The BSA-II independently executes moderately complex assignments within established system governance and validation frameworks. The BSA-II will report directly to the CSV Manager and work closely with members of the CSV team, IT, QA, Business and System Owners. Essential Duties and
Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time. Obtain, analyze, document, and validate business, functional, and system requirements for new and existing applications supporting GxP business processes. Translate business and regulatory requirements into system‑based solutions in collaboration with IT, Quality, system owners, the business and vendors.
Assess the impact of system changes on validated state, business processes, and data integrity. Support CSV activities across the system lifecycle, including i