Location: Remote (NJ Preferred)
Tenure: 12+ months
Job Description:
This position sits at the intersection of Data Quality, Regulatory Compliance, and Generative AI (Gen AI), driving digital transformation in GxP-regulated environments. The Business Analyst will collaborate closely with Quality, Data Science, and Technology teams to enhance AI-enabled quality processes, ensure data integrity, and foster compliant innovation.
Key Responsibilities:
- Partner with Quality, Regulatory, and Business stakeholders to gather and formalize requirements in line with Pharma GxP and compliance standards.
- Translate business needs into validated requirements (URS/FRS), user stories, and acceptance criteria.
- Drive initiatives focused on data integrity, data quality frameworks, and governance based on ALCOA+ principles.
- Identify and define Gen AI use cases, such as deviation analysis, CAPA automation, document intelligence, and audit readiness.
- Collaborate with Data Science and AI teams to define model inputs/outputs, validation and explainability requirements, and risk and compliance controls for AI solutions.
- Facilitate workshops with cross-functional teams, including Quality Assurance (QA), IT, Data Engineering, and Regulatory Affairs.
- Support computer system validation (CSV).
- Develop and maintain documentation, including BRDs, FRS, traceability matrices, data lineage, data mapping artifacts, process flows, and SOP-aligned documentation.
- Support UAT and validation cycles, ensuring solutions meet both business and regulatory expectations.
- Act as a bridge between business, IT, and AI/analytics teams in a highly regulated environment.
Required Skills & Qualifications:
- 8+ years of experience as a Business Analyst in Life Sciences/Pharma environments.
- Strong experience in Quality, data governance, and data quality management.
- Proven exposure to GxP environments, regulatory compliance, and validation processes (CSV).
Never miss an opportunity! Create an alert based on the job you applied for.