Responsibilities:
- Design, implement, maintain, and continuously improve SLC framework across technology systems and platforms using a patient-centric, risk-based approach aligned with GAMP principles.
- Drive controls automation: automate collection, validation, and reporting of IT control evidence within CI/CD pipelines and integrated toolchains; use electronic evidence consistent with FDA/industry CSA guidance.
- Leverage AI for enhanced control monitoring, trend analysis, and anomaly detection; govern compliance and data integrity implications of self-learning systems.
- Bridge compliance and technology teams: translate governance and regulatory requirements into tool configuration and pipeline design.
- Partner with tool owners (Jira, GitHub, JFrog, qTest, ServiceNow, etc.) to embed controls at the source and ensure correct evidence output.
- Maintain digital traceability linking requirements, controls, design elements, and verification evidence; keep records live, dynamic, and audit-ready.
- Ensure data integrity by design using ALCOA+ and data lifecycle controls.
- Support audit/inspection readiness: lead evidence preparation and coordinate remediation.
- Enable governance stakeholders: surface interdependencies and communicate control status in compliance-relevant language.
- Contribute to continuous improvement aligned with Validation 4.0.
Qualifications:
Required:
- Bachelorโs (6 years), Masterโs (5 years), or PhD (0 years) relevant experience.
- Regulated industry experience (pharma, medical device, or similar).
- Fluency with toolchains: GitHub, Jira, JFrog Artifactory, qTest, ServiceNow CMDB and/or CI/CD (Azure DevOps, AWS CodePipeline, or equivalent).
- Ability to translate regulatory requirements into technical specifications, acceptance criteria, and control configurations.
- Experience embedding controls into DevOps workflows/pipelines.
- Ability to communicate credibly with both governance and engineering teams.
- Ability to learn and work in a fast-paced environment.
Preferred:
- Familiarity with AI systems in regulated contexts (governance, validation, data integrity).
Benefits (if explicitly stated):
- Paid time off; medical/dental/vision insurance; 401(k); short-term incentive program eligibility.