Director of Quality Assurance

Medicines360

Director of Quality Assurance leading QMS, GXP compliance, audits, and product quality for Medicines360’s women’s health products. Guiding medical-device development and commercialization.

Posted 8/7/2026full-timeSan Francisco • California • 🇺🇸 United StatesLead💰 $200,000 - $215,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive experience in Quality Assurance management, including the development and maintenance of Quality Management Systems and compliance with US FDA regulatory requirements. Proven ability to lead cross-functional teams, manage supplier relationships, and implement continuous quality improvement strategies.

Highest-signal resume keywords

Quality Management System (QMS) ManagementUS FDA Regulatory Requirements ExpertiseGXP Compliance and Training DevelopmentVeeva EDMS AdministrationQuality Assurance Leadership

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Quality AssuranceGXP Policies and SOPsRegulatory SubmissionsRisk Management PrinciplesSupplier Qualification ProgramsInternal Audit Program ImplementationProduct Release ManagementChange Control ManagementCAPA ManagementQuality Metrics and Reporting

Soft Skills

Strong Organizational SkillsExcellent Communication SkillsTeam LeadershipMentoring and CoachingCross-Functional Collaboration

Tools & Technologies

Veeva QMSEDMSWord Processing SoftwareSpreadsheetsDatabases

Certifications & Qualifications

Designated Representative Certification for Wholesaler

Industry Keywords

CGMPGLPGCPGVPISO StandardsCombination ProductsMedical DevicesQuality CultureClinical StudiesSupplier Audits

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Provide strategic and operational leadership for Medicines360’s Quality and GXP activities
Manage the Quality Management System, QA personnel, and quality initiatives
Create, maintain, review, and approve GXP policies, SOPs, and supporting documents
Lead QMS programs including change control, deviations and investigations, complaints, CAPAs, metrics, and reporting
Develop and manage GXP training programs
Maintain and implement supplier qualification programs, conduct supplier audits, develop quality agreements, and monitor supplier performance
Implement the internal audit program and support inspection readiness
Serve as primary backup system administrator for Veeva EDMS and oversee internal EDMS administration
Manage regulatory inspections and audits with the Head of Quality and Regulatory Affairs
Develop continuous quality improvement strategies and strengthen the organization’s Quality culture
Provide Quality and CMC guidance during due diligence, product development, commercialization, clinical studies, and regulatory submissions
Ensure GCP compliance, supplier qualification, and execution of company SOPs for clinical studies
Perform product release for investigational and commercial distribution
Oversee product complaints and review post-marketing surveillance reports
Manage DHFs and Quality and CMC information for regulatory submissions and information requests
Participate in supply chain planning and commercial distribution activities
Monitor the impact of new regulatory requirements on the company, QA function, and product pipeline
Establish and maintain the internal library of standards and technical publications
Manage external quality partners, vendors, and consultants
Manage and mentor QA personnel for career development and advancement

Requirements

What you’ll need

Bachelor level degree in a relevant scientific discipline required; advanced degree preferred
Minimum of 10 years of Quality Assurance experience, including at least 5 years in a management role
Experience developing, managing, and maintaining Quality systems for medical devices in development and commercial stages required
Experience with combination products desired
Experience implementing Quality systems at virtual organizations, such as specification developers
Expert knowledge of US FDA regulatory requirements, including cGMP, GLP, GCP, GVP, QMSR, and ISO standards
Experience applying risk management principles to decision making
Experience engaging vendors and CMOs, including relationship management and performance monitoring
Ability and willingness to be certified as a Designated Representative for a Wholesaler through the California State Board of Pharmacy
Availability for domestic and international travel
Strong organizational and technical skills, including word processing, spreadsheets, databases, and online research
Experience with Veeva QMS preferred
Excellent verbal, written, and communication skills
Ability to prioritize multiple assignments in a fast-paced office environment
Ability to communicate priorities across departments, leadership, and cross-functional teams
Ability to manage external partners and teams locally and globally across multiple time zones
Ability to work independently and cross-functionally as a team player
Ability to manage and lead departments and cross-functional teams
Ability to develop department personnel through coaching and mentoring
Must be able to remain stationary 50% of the time and occasionally move throughout the office
Continuously operate a computer and occasionally use office productivity machinery
Ability to communicate and exchange accurate information
Ability to observe details at close range

Benefits

Comp & perks

Hybrid work arrangement with in-office presence Tuesday, Wednesday, and Thursday
Full-time, exempt employment
Career development and advancement opportunities through coaching and mentoring
Diverse workplace and equal opportunity employment