Sr Software Quality and Regulatory Analyst (Leader)

SAS•Cary, NC

37d•Hybrid

About The Position

The SAS Health and Life Sciences Research & Development team is seeking an experienced analyst to lead software quality and regulatory practices across a portfolio of software products and services delivered to regulated and non-regulated industries. The role manages and continuously improves the organization’s Quality Management System (QMS), scaled for a software vendor serving healthcare and regulated clinical-trial clients. The leader will embed modern quality engineering practices across the end-to-end software development lifecycle while ensuring standard operating procedures are documented, followed, and auditable. The role ensures the SDLC produces objective evidence for internal release decisions and customer validation packages, and translates 21 CFR Part 11 requirements into concrete product requirements. It also owns controlled document management, client validation materials, quality engineering metrics, and internal and external audit programs. The work supports life sciences companies and healthcare payers and providers in delivering medications and services.

Requirements

Bachelor’s degree in life sciences, engineering, computer science, or a related field; an advanced degree is a plus.
Experience running Quality Management Systems for commercial software at scale.
At least 5 years of experience in quality and/or regulatory roles within software organizations supporting regulated industries.
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, including the ability to translate regulatory requirements into engineering and product language and vice versa.
Equivalent combinations of related education, training, and experience may be considered.

Nice To Haves

Prior experience building or scaling a quality/regulatory function.
Familiarity with healthcare-relevant, non-regulated frameworks such as HIPAA, HITRUST, and SOC 2 for non-GxP products.
Experience implementing shift-left quality practices, test-driven development, CI/CD-integrated test automation at scale, and other modern best practices.
Experience with performance/load testing tools such as k6, JMeter, or Gatling, and observability platforms.
Understanding of the value of AI-assisted testing tools, including test-case generation, synthetic test data, and automated results validation, with appropriate governance.

Responsibilities

Establish, own, and continuously improve the organization’s Quality Management System, scaled for a software vendor serving healthcare and regulated clinical-trial clients.
Ensure the Software Development Life Cycle produces objective evidence for internal release decisions and customer validation packages, including requirements specifications, risk assessments, traceability matrices, test protocols and results, and validation summary reports.
Translate 21 CFR Part 11 requirements into product requirements, including audit trails, electronic signatures, access controls, record retention and export, and time synchronization.
Own document control for SOPs, work instructions, templates, and quality records across engineering, product, and support.
Balance modern engineering practices with the documentation and traceability rigor required for regulated releases.
Own the validation and qualification package provided to clients for their own regulated system use.
Define and track quality engineering metrics to prioritize tooling and process investment.
Lead internal and external audit programs, including preparation, execution, reporting, and compliance actions.

Benefits

Comprehensive medical, prescription, dental, and vision plans.
PPO medical plan option with a low annual deductible and copays.
HDHP option combined with a health savings account and an employer contribution.
On-site health care center at headquarters, free to employees and family members enrolled in the PPO plan.
On-site pharmacy, with prescriptions shipped at no additional charge to employees who are not local to headquarters.
Industry-leading 401(k) plan.
Tuition Assistance Program and programs and resources to support employee development.
Vacation time and paid holidays, including a U.S. Winter Wellness Break between December 25 and January 1.
Volunteer Time Off.
Parental leave.
Unlimited paid sick days.
Childcare benefits for full-time employees.