Business Systems Analyst II

Nature and ScopeThe 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 GxPregulated 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 Responsibilities

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 systembased 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 implementation, configuration changes, upgrades, and retirement.
• Author, review, approve and maintain CSV deliverables including User Requirements Specifications (URS), Risk assessments (e.g., system impact, data integrity, patient safety), Functional Specification (FS), Configuration Specifications (CS), Security Specifications (SS), Design Specifications (DS), Qualification Protocols (IQ/OQ/PQ), Traceability matrices, Validation plans and summary documentation (as applicable).
• Ensure system requirements are testable, traceable, and inspectionready.
• Ensure system changes are appropriately assessed for risk and documented according to change management procedures.
• Identify and communicate data integrity, compliance, or validation risks associated with system changes.
• Contribute to audit and inspection readiness activities by ensuring documentation is complete, current, and accurate.
• Support responses to audit/inspection requests and observations related to computerized systems, when applicable.
• Support system implementations including validation execution and support testing activities (e.g., IQ/OQ/PQ/UAT, protocol review, defect assessment), enhancements, periodic reviews, and retirement activities.
• Participate in development and maintenance of SOPs, work instructions, and validated system documentation.
• Partner with Quality, Manufacturing, Supply Chain, Regulatory, IT, and other stakeholders to align system functionality with regulated business needs and to support continuous improvement while maintaining compliance.
• Facilitate workshops, risk discussions, and validation reviews to obtain requirements.
• Communicate effectively with both technical and nontechnical stakeholders using clear, structured communication and documentation.
• Consistently perform all duties in accordance with American Regent and Daiichi Sankyo Business Principles, corporate directives, SOPs, policies, and government and industry regulatory guidelines.
• Perform any other tasks/duties as assigned by management.

Education Requirements and Qualifications

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required.