Senior Quality & Compliance Leader — QMS & Validation

Ingenuity Staffing; Westlake Village (CA); On-site; USD 140,000 - 190,000; Full time

Job summary

Ingenuity Staffing is looking for a seasoned quality leader to guide a high-growth, regulated hardware and life sciences platform. You will own scalable, audit-ready systems ensuring strict compliance across complex supply chains.

You will lead the Enterprise QMS, drive validation strategies (IQ/OQ/PQ), and implement HITRUST-aligned security and data integrity frameworks. Collaboration with Engineering, Operations and Commercial teams will enable compliant growth.

Qualifications

• 7+ years in regulated quality/compliance environments.
• Experience building or scaling a QMS.
• Background in electronic systems validation.
• Familiarity with FDA 21 CFR Part 11 & GxP documentation standards.
• Ability to translate technical architecture into structured validation frameworks.
• Executive presence and cross-functional leadership.

Responsibilities

• Own Enterprise Quality Management System leadership.
• Drive IQ/OQ/PQ validation strategy and documentation.
• Governing HITRUST-aligned security and data integrity frameworks.
• Collaborate with Engineering, Operations and Commercial teams to build audit-ready scalable systems.

Skills

Regulated quality

Executive leadership

Cross-functional collaboration

Validation framework design

QMS deployment

Tools

QMS platforms

Electronic signatures

Job description

Ingenuity Staffing is looking for a seasoned quality leader to guide a high-growth, regulated hardware and life sciences platform. You will own scalable, audit-ready systems ensuring strict compliance across complex supply chains.

You will lead the Enterprise QMS, drive validation strategies (IQ/OQ/PQ), and implement HITRUST-aligned security and data integrity frameworks. Collaboration with Engineering, Operations and Commercial teams will enable compliant growth.