Sr Software Quality and Regulatory Analyst (Leader)

Senior Quality and Regulatory (Leader) – Hybrid, Cary, NC

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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.

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, 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.

You are welcome here.

At SAS, it’s not about fitting into our culture – it’s about adding to it. We believe our people make the difference. Our inclusive workforce brings together unique talents and inspires teams to create amazing software that reflects the diversity of our users and customers.

Additional Information

To qualify, applicants must be legally authorized to work in the United States, and should not require, now or in the future, sponsorship for employment visa status. SAS is an equal opportunity employer. All qualified applicants are considered for employment without regard to any characteristic protected by law.

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