Sr Software Quality and Regulatory Analyst; Leader

Position: Sr Software Quality and Regulatory Analyst (Leader)
Senior Quality and Regulatory (Leader) – Hybrid, Cary, NC We’re a leader in data and AI. Through our software and services, we inspire customers around the world to transform data into intelligence – and questions into answers.  If you’re looking for a dynamic, fulfilling career with flexibility and a world-class employee experience, you’ll find it here. We’re recognized around the world for our inclusive, meaningful culture and innovative technologies by organizations like Fast Company, Forbes, Newsweek and more.

About the job    The SAS Health and Life Sciences Research & Development team is looking for an experienced analyst to manage the software quality management system across the portfolio including delivery and deployment, into regulated and non-regulated industries. This leadership role will drive modern quality engineering practices into the end-to-end software development cycle including ensuring standard operating procedures are documented, executed and auditable (ie 21

CFR 11) by internal and external stakeholders.  When executed well, this role will have a direct, positive impact on enhancing life sciences and healthcare clients to deliver lifesaving medications and services to their clients.  As a Quality and Regulatory Leader, you will:    Establish, own, and continuously improve the organization’s Quality Management System (QMS), scaled appropriately for a software vendor serving healthcare and regulated clinical trial customers.

Ensure the Software Development Life Cycle (SDLC) produces objective evidence suitable both for internal release decisions and for customer validation packages: requirements specifications, risk assessments, traceability matrices, test protocols and results, and validation summary reports.

Translate 21 CFR Part 11 requirements into concrete product requirements: audit trails, electronic signatures, access controls, record retention and export, and time synchronization.

Own document control for controlled records: SOPs, work instructions, templates, and quality records across engineering, product, and support.

Balance high-velocity modern engineering practices with the documentation and traceability rigor required for regulated releases, so both regulated and non-regulated products benefit from the same quality foundation.

Define and track quality engineering metrics to prioritize tooling and process investment.

Own the validation/qualification package provided to clients so they can validate the system for their own regulated use.

Lead internal and external audit programs including preparations, execution and reporting and associated actions. Embrace collaboration, curiosity, passion, authenticity and accountability. These are our values and influence everything we do. Required qualifications  Bachelor's degree in life sciences, engineering, computer science, or a related field (advanced degree a plus).Experience running a Quality Management Systems for commercial software at scale Minimum 5 years of experience in quality and/or regulatory roles within software organizations supporting regulated industries

Demonstrated in depth knowledge of 21 CFR Part 11 principles and other relevant standards

Experience supporting client audits and vendor due-diligence processes in regulated industries

Excellent written and verbal communication skills, with the ability to translate regulatory requirements into engineering and product language, and vice versa.

Additional competencies, knowledge and skills Prior experience building or scaling a quality/regulatory function

Familiarity with healthcare-relevant, non-regulated frameworks (HIPAA, HITRUST, SOC
2) for non-GxP products.

Demonstrated experience implementing shift-left quality practices, test-driven development,…