Quality and Compliance Manager

Quality and Compliance Manager
Location: Los Angeles, CA (Onsite)
Compensation: Competitive total compensation package

Overview
A rapidly growing technology platform company operating in the healthcare and regulated logistics space is seeking a Quality and Compliance Manager to lead the development and management of its Quality Management System and regulatory compliance programs. This role supports both hardware and digital infrastructure platforms and plays a key role in ensuring operational scalability while maintaining strict regulatory and data integrity standards.

The ideal candidate is hands on, systems oriented, and comfortable working across engineering, manufacturing, software infrastructure, logistics partners, and executive leadership.

Responsibilities

Quality Management System Leadership

• Maintain and continuously improve the company's Quality Management System
• Develop, control, and audit SOPs, work instructions, and quality policies
• Lead internal audits and prepare the organization for customer and regulatory audits
• Manage CAPA, change control, deviation management, and document control processes
• Ensure full traceability across validation documentation including URS, IQ, OQ, and PQ

Regulatory and Compliance Oversight

• Ensure compliance with FDA 21 CFR Part 11 requirements for electronic records and system validation
• Maintain alignment with GxP and GDP regulatory standards
• Ensure data integrity practices consistent with ALCOA+ principles
• Maintain compliance with HITRUST security framework controls
• Partner with engineering teams to validate system architecture including AWS infrastructure controls, audit trails, backup and recovery processes, and authentication systems
• Support regulatory submissions and customer qualification documentation

Validation and Verification Programs

• Own execution and documentation of IQ, OQ, and PQ validation programs
• Maintain traceability matrices linking user requirements, test protocols, and validation evidence
• Oversee shipping lane validation studies for regulated product transport
• Validate firmware releases and telemetry system updates
• Coordinate with third party validation consultants when required

Supplier Quality and Manufacturing Compliance

• Develop and maintain supplier quality agreements
• Audit and oversee contract manufacturers and packaging partners
• Review and approve supplier documentation including Certificates of Compliance, Business Continuity Plans, Disaster Recovery Plans, environmental declarations, and component traceability records
• Monitor engineering change notifications and product change notifications
• Ensure incoming inspection standards and field performance feedback loops are implemented

Risk Management and Continuous Improvement

• Maintain risk registers including FMEA, DFMEA, and PFMEA
• Conduct root cause investigations for quality events and deviations
• Lead structured corrective and preventive action initiatives
• Participate in cross functional design reviews
• Implement data driven quality metrics and continuous improvement initiatives

Customer and Commercial Support

• Prepare validation summaries and executive level compliance packages
• Support onboarding of pharmaceutical and regulated customers
• Respond to quality and compliance questionnaires during customer qualification processes
• Partner with business development and sales teams to support compliance positioning during RFP processes

Qualifications

• Bachelor's degree in Engineering, Life Sciences, Quality, or related technical field
• Minimum 7 years of experience in a regulated quality or compliance environment
• Demonstrated experience building or scaling a Quality Management System
• Experience implementing document control, CAPA programs, change control processes, and audit programs
• Strong cross functional leadership with ability to drive implementation across engineering and operations teams
• Experience with HITRUST, FDA 21 CFR Part 11, electronic systems validation, and GxP documentation standards
• Strong documentation discipline and audit readiness experience
• Ability to translate technical architecture and engineering systems into validation documentation

Preferred Experience

• Medical device or regulated life sciences environment
• Pharmaceutical cold chain logistics
• IoT hardware platforms integrated with cloud systems
• AWS infrastructure validation environments
• HITRUST or SOC 2 compliance frameworks
• Shipping lane validation protocols
• ASQ Certified Quality Engineer or similar certification
• Startup or high growth company experience

Key Competencies

• Systems thinking and structured problem solving
• Strong attention to detail with practical business judgment
• Effective cross functional communication
• Ability to build compliant processes while supporting operational growth
• High standards for documentation integrity and data quality

Success Metrics (First 12 Months)

• Fully operational and audit ready Quality Management System
• Successful internal audit completion with documented corrective action closure
• Established and validated IQ, OQ, and PQ framework
• Supplier quality agreements implemented across manufacturing partners
• Successful qualification of regulated pharmaceutical customers
• Documented alignment with HITRUST framework and validated 21 CFR Part 11 system controls