Senior Quality & Regulatory Leader — Regulated Software

Sas; Cary (NC); Híbrido; USD 140 000 - 190 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Comprehensive medical plan

Industry-leading 401k

Tuition Assistance Program

Generous paid time off & holidays

Winter Wellness Break

Parental leave

Childcare benefits

Resumo da oferta

SAS is seeking a Senior Quality and Regulatory Leader in Cary, NC, to manage the organization’s Quality Management System for software across regulated and non-regulated industries. You will drive modern quality engineering practices in the SDLC, maintain auditable SOPs, and lead audits with internal and external stakeholders.

You will translate CFR Part 11 requirements into product requirements and own validation packages for clients, while balancing speed with regulatory rigor, contributing to

Qualificações

• Experience running a Quality Management System for commercial software at scale.
• Minimum 5 years of experience in quality and/or regulatory roles within software organizations
• Demonstrated knowledge of 21 CFR Part 11 principles and related standards
• Ability to translate regulatory requirements into engineering and product language
• Experience supporting client audits and vendor due-diligence in regulated industries
• Excellent written and verbal communication skills

Responsabilidades

• Establish, own, and continuously improve the organization’s Quality Management System for software in healthcare and regulated clients.
• Ensure SDLC delivers objective evidence for release decisions and client validation.
• Translate 21 CFR Part 11 requirements into product features: audit trails, electronic signatures, access controls, retention and export.
• Own document control for SOPs, work instructions, templates, and quality records.
• Balance rapid engineering with rigorous documentation for regulated and non-regulated products.
• Own the validation/qualification package provided to clients for their regulated use.
• Define and track quality metrics to guide tooling and process investments.
• Lead internal and external audit programs: preparations, execution, reporting, and compliance actions.
• Foster collaboration, curiosity, accountability, and a strong quality culture.

Conhecimentos

Quality management

Regulatory compliance

Software validation

GxP awareness

Regulated industry

Formação académica

Bachelor's degree in life sciences/engineering/CS

Advanced degree optional

Descrição da oferta de emprego

SAS is seeking a Senior Quality and Regulatory Leader in Cary, NC, to manage the organization’s Quality Management System for software across regulated and non-regulated industries. You will drive modern quality engineering practices in the SDLC, maintain auditable SOPs, and lead audits with internal and external stakeholders.

You will translate CFR Part 11 requirements into product requirements and own validation packages for clients, while balancing speed with regulatory rigor, contributing to