QA Analyst

About The Company

We are a recognized leader in data and artificial intelligence, providing innovative software and services that empower customers worldwide to transform data into actionable intelligence. Our solutions enable organizations to convert complex questions into clear answers, driving impactful business decisions. We pride ourselves on fostering a dynamic and inclusive culture, offering a world-class employee experience with flexibility and growth opportunities. Our commitment to innovation and inclusivity has earned us accolades from prestigious organizations such as Fast Company, Forbes, and Newsweek.

About The Role

The Senior Quality and Regulatory Leader will be a key member of the SAS Health and Life Sciences Research & Development team, responsible for managing the software quality management system across a diverse portfolio serving both regulated and non-regulated industries. This hybrid role, based in Cary, NC, requires a strategic leader to drive modern quality engineering practices throughout the software development lifecycle. The successful candidate will ensure that standard operating procedures are well-documented, executed, and auditable in compliance with regulatory requirements such as 21 CFR Part 11. By effectively managing quality and regulatory processes, this role will directly contribute to enhancing the delivery of lifesaving medications and services to healthcare and life sciences clients. The leader will balance the speed of modern engineering practices with the rigor needed for regulatory compliance, fostering continuous improvement and collaboration across teams.

Qualifications

• Bachelor’s degree in life sciences, engineering, computer science, or a related field; advanced degree preferred
• Minimum 5 years of experience in quality and/or regulatory roles within software organizations supporting regulated industries
• Proven experience managing Quality Management Systems (QMS) for commercial software at scale
• In-depth knowledge of 21 CFR Part 11 and other relevant regulatory standards
• Experience supporting client audits and vendor due-diligence in regulated environments
• Excellent written and verbal communication skills, with the ability to translate regulatory requirements into engineering and product language, and vice versa
• Prior experience building or scaling quality/regulatory functions is highly desirable
• Familiarity with healthcare-relevant, non-regulated frameworks such as HIPAA, HITRUST, and SOC 2
• Demonstrated expertise in implementing shift-left quality practices, test-driven development, and CI/CD-integrated test automation
• Experience with performance/load testing tools (e.g., k6, JMeter, Gatling) and observability platforms
• Understanding of AI-assisted testing tools and governance for test case generation, synthetic test data, and automated results validation

Responsibilities

• Establish, own, and continuously improve the organization’s Quality Management System (QMS) tailored for healthcare and regulated clinical trial software products
• Ensure the Software Development Life Cycle (SDLC) produces objective evidence including requirements specifications, risk assessments, traceability matrices, test protocols, results, and validation summary reports
• Translate 21 CFR Part 11 regulatory requirements into actionable product features such as audit trails, electronic signatures, access controls, record retention, and time synchronization
• Manage document control for controlled records including SOPs, work instructions, templates, and quality records across engineering, product, and support teams
• Balance rapid engineering practices with the documentation and traceability rigor required for regulated releases, ensuring quality standards benefit both regulated and non-regulated products
• Define and track quality engineering metrics to guide tooling and process investments
• Own the validation and qualification packages provided to clients for system validation in regulated environments
• Lead internal and external audit programs including preparation, execution, reporting, and follow-up actions
• Foster a collaborative environment aligned with company values of curiosity, passion, authenticity, and accountability

Benefits

• Comprehensive medical, prescription, dental, and vision insurance plans
• Medical plan options including PPO with low deductibles and copays, and High Deductible Health Plan (HDHP) paired with a Health Savings Account (HSA) funded by the company
• Access to an onsite Health Care Center at headquarters for employees and their families enrolled in the PPO plan, including an onsite pharmacy with free prescription shipping for remote employees
• Industry-leading 401(k) retirement plan
• Tuition Assistance Program and various professional development resources
• Generous paid time off including vacation, paid holidays, and a Winter Wellness Break between December 25 and January 1
• Volunteer Time Off, parental leave, and unlimited paid sick days
• Childcare benefits available for full-time employees

Equal Opportunity

We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or any other characteristic protected by law. We celebrate diversity and are committed to creating an inclusive environment for all employees.