Director of Quality Assurance

• 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

• 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

Core Competencies

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) Management
• US FDA Regulatory Requirements Expertise
• GXP Compliance and Training Development
• Veeva EDMS Administration
• Quality Assurance Leadership

ATS Optimization Keywords

Hard Skills

• Quality Assurance
• GXP Policies and SOPs
• Regulatory Submissions
• Risk Management Principles
• Supplier Qualification Programs
• Internal Audit Program Implementation
• Product Release Management
• Change Control Management
• CAPA Management
• Quality Metrics and Reporting

Soft Skills

• Strong Organizational Skills
• Excellent Communication Skills
• Team Leadership
• Mentoring and Coaching
• Cross-Functional Collaboration

Certifications & Qualifications

• Designated Representative Certification for Wholesaler

Industry Keywords

• CGMP
• GLP
• GCP
• GVP
• ISO Standards
• Combination Products
• Medical Devices
• Quality Culture
• Clinical Studies
• Supplier Audits

Tools & Technologies

• Veeva QMS
• EDMS
• Word Processing Software
• Spreadsheets
• Databases