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 companys 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

Bachelors 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