Sr Software Quality and Regulatory Analyst (Leader)

SAS•Cary, NC

12d•Hybrid

About The Position

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 21CFR 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.

Requirements

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.

Nice To Haves

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, and CI/CD-integrated test automation at scale and other modern best practices
Experience with performance/load testing tools (e.g., k6, JMeter, Gatling) and observability platforms.
Demonstrated understanding of the value in deploying AI-assisted testing tools (test case generation, synthetic test data, automated results validation) with appropriate governance.

Responsibilities

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.

Benefits

Comprehensive medical, prescription, dental and vision plans.
PPO with low annual deductible and copays.
HDHP combined with a health savings account with a contribution from SAS (no access to on-site health care center).
Onsite Health Care Center (HQ) that’s free to employees and family members enrolled in the PPO plan.
Pharmacy services.
An industry-leading 401k plan.
Tuition Assistance Program and programs and resources to support your development
Generous time away including vacation time, a variety of paid holidays, and our much-loved U.S. Winter Wellness Break between December 25 and January 1.
Volunteer Time Off, parental leave and unlimited paid sick days.
Generous childcare benefits for all full-time employees.