Position Title: Director of Quality Assurance Reports To: Head of Quality and Regulatory Affairs FLSA Status: Full-time, Exempt Location: San Francisco - Hybrid IN OFFICE PRESENCE: Tuesday, Wednesday & Thursday POSITION SUMMARY: The Director of Quality Assurance provides strategic and operational leadership for the Quality and GXP activities of Medicines360 and its affiliates. Medicines360 is a commercial and development stage company with an approved complex drug-device combination product and a development pipeline of device products. The Director of Quality Assurance manages the Medicines360 Quality Management System, QA personnel, and Quality initiatives, ensuring compliance with US FDA regulations, ISO 13485, and global regulatory requirements. S/he translates the company's quality strategy into tactical and pragmatic policies, processes, and procedures to effectively meet global standards and ensure the overall quality of Medicines360 products. S/he will collaborate closely with the Head of Quality and Regulatory Affairs, internal functional areas, external partners, contract facilities, and suppliers to drive continuous improvement in quality and support regulatory compliance and product safety from early product development through the post-marketing stage of product lifecycles. ESSENTIAL DUTIES AND RESPONSIBILITIES: - Manages and maintains an effective Quality Management System, ensuring compliance with US FDA regulations, ISO 13485, and global regulatory requirements. - Create, maintain, review, and approve GXP-related Policies, SOPs (Standard Operating Procedures), and supporting GXP documents. - Leads the programs and processes within the QMS, including change control, deviations and investigations, complaints, CAPAs, metrics and reporting. - Develops and manages GXP training programs for personnel in collaboration with the other functional heads. - Maintain and implement the supplier qualification program, including conducting supplier audits, developing quality agreements, and monitoring supplier performance. - Implements the internal audit program. - Serves as the primary back-up system administrator for the Veeva EDMS. - Ensures inspection readiness and, in coordination with the Head of Quality and Regulatory Affairs, manages regulatory inspections and audits. - Develops and implements strategies for continuous quality improvement to support evolving regulations, product innovation, and a strong Quality culture across the organization. - Provides Quality and CMC guidance and oversight during new product due diligence, product development, and commercialization. - Provides Quality guidance for clinical studies to ensure GCP compliance, qualification of suppliers, and execution of Medicines360 SOPs - Performs product release for investigational and commercial distribution. - Oversees product complaints and reviews post-marketing surveillance reports. - Works closely with the Regulatory function to develop Quality and CMC content for submissions, manage DHFs, address Quality and CMC information in information requests, and represent the Quality function in regulatory interactions. - Participate in supply chain planning and commercial distribution activities. - Monitors and assesses the impact of new regulatory requirements on the company, QA function, and product pipeline. - Establishes and maintains the internal library of standards and technical publications - Manages relationships with external quality partners, including vendors and consultants - Oversees the effective administration of the internal EDMS for the company. - Manages and mentors QA personnel for career development and advancement. ESSENTIAL SKILLS & QUALIFICATIONS: - Bachelor level degree in a relevant scientific discipline; advanced degree is preferred - Minimum of 10 years of Quality Assurance experience, with at least 5 years in a management role - Experience developing, managing, and maintaining Quality systems for medical devices in development and commercial stages is required; experience with combination products is desired - Experience implementing Quality systems at virtual organizations (e.g., specification developer) - Expert knowledge of US FDA Regulatory requirements (cGMP / GLP / GCP / GVP / QMSR / ISO) and other applicable (e.g., international) standards of compliance - 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 CA State Board of Pharmacy - Availability for travel, both domestic and international - Requires strong organizational and technical skills (e.g., word processing, spreadsheets, databases, online research) - Experience with Veeva QMS is preferred - Requires excellent verbal, written, and communication skills - Ability to prioritize multiple assignments in a fast-pace office environment and communicate those priorities within the department, to leadership, and across cross-functional teams - Ability to effectively communicate with and manage multiple external partners and teams, locally and globally, including availability for collaboration across multiple time zones - Ability to work independently and as a team player cross-functionally - Ability to effectively manage and lead the department and, when needed, cross-functional teams - Ability to effectively develop a department and its personnel, including coaching and mentoring IN OFFICE PRESENCE: Tuesday, Wednesday & Thursday PHYSICAL DEMANDS/MISC: - Must be able to remain in a stationary position 50% of the time. - The person in this position may need to occasionally move throughout the office to attend meetings in different rooms. - Continuously operates a computer and occasionally uses other office productivity machinery, such as copy machines, and computer printer. - The ability to communicate information and ideas so others will understand. Must be able to exchange accurate information in these situations. - The ability to observe details at close range (within a few feet of the observer).