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 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 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 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 inspection‑ready.
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 non‑technical 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.
Bachelor’s degree in Information Systems, Engineering, Business, Computer Science, or STEM related discipline (or equivalent experience).
3–6 years of experience as a Business Systems Analyst, Business Analyst, Computer System Validation or similar role.
Hands‑on experience supporting administrative activities for validated or GxP‑regulated computerized systems.
Experience working within SDLC and CSV frameworks in a pharmaceutical, biotech, or other regulated environment.
Strong requirements elicitation and documentation skills in regulated environments.
Working knowledge of CSV concepts, including requirements, risk management, and traceability.
Strong understanding of FDA, EU, GAMP, ICH and data integrity expectations for computerized systems.
Ability to apply risk‑based thinking to validation and system changes.
Strong analytical, organizational, and problem‑solving skills.
Clear written and verbal communication suitable for audits and inspections.
Ability to manage multiple priorities while maintaining compliance rigor.
Experience with FDA Computer Software Assurance (CSA) and Computer Software Validation (CSV) principles.
Experience supporting validated COTS platforms (e.g., LIMS, QMS, ERP, TrackWise, Veeva, SAP, MES, Empower, OpenLab, Chromeleon).
Experience with change control, periodic reviews, and system retirement activities.
Experience using validation lifecycle management tools (e.g., Res_Q, ValGenesis, KNEAT).
Physical Environment and Requirements
Physically able to wear cleanroom/protective gowning and equipment, including but not limited to gowning, goggles, face shields, and protective gloves. PPE is essential for the health and safety of employees.
American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status.
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