Job DescriptionSenior Quality and Regulatory (Leader) - Hybrid, Cary, NC 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 21CFR 11) by internal and external stakeholders.
This role will have a direct, and positive impact on life sciences companies and healthcare payers and providers enabling them to efficiently and effectively 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 clients.
- 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.
- Own the validation/qualification package provided to clients so they can validate the system for their own regulated use.
- 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, reporting and compliance 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, 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.
World-class benefits Highlights include...
- Comprehensive medical, prescription, dental and vision plans.
- Medical plan options include:
- 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. There's a pharmacy too! Not local to HQ? The pharmacy will ship prescriptions for no additional charge!
- 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.
