Quality Compliance Manager

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

Are you a quality leader who thrives in regulated environments and enjoys building structured systems that scale?

We’re partnering with a high-growth innovator operating at the intersection of regulated hardware, cloud platforms, and life sciences infrastructure. This organization is redefining how compliance-critical, temperature-sensitive products are validated, monitored, and delivered across complex supply chains.

This is a highly visible role with executive exposure and meaningful impact.

What You’ll Own

• Enterprise Quality Management System (QMS) leadership
• IQ / OQ / PQ validation strategy and documentation
• HITRUST-aligned security and data integrity frameworks

You’ll work cross-functionally with Engineering, Operations, and Commercial teams to build audit-ready, scalable systems that enable growth without compromising compliance.

What We’re Looking For

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

Experience in medical device, pharmaceutical, cold chain, IoT hardware, or cloud platforms is highly preferred.

Why This Role?

This is an opportunity to shape foundational compliance architecture inside a rapidly scaling organization. The right leader will not just maintain quality — they will define it.