Director of Quality Assurance
$200,000–$215,000 year
HybridSan Francisco, California, United States
Job Summary
Manage the Quality Management System and QA personnel to ensure compliance with US FDA regulations, ISO 13485, and global standards. Create, review, and approve GXP policies, SOPs, and documents while leading programs for change control, deviations, investigations, and CAPAs. Develop GXP training programs, oversee supplier qualification and audits, and implement internal audit programs. Serve as primary backup system administrator for Veeva EDMS and ensure inspection readiness for regulatory audits. Provide Quality and CMC guidance during product development and commercialization, perform product release, and oversee post-marketing surveillance. Collaborate with the Regulatory function on submissions and supply chain planning. Monitor regulatory impacts, maintain technical publications, and mentor QA staff. Full-time exempt role in San Francisco; hybrid schedule with Tuesday, Wednesday, and Thursday in-office presence.
Required Qualifications
- Bachelor level degree in a relevant scientific discipline
- Minimum of 10 years of Quality Assurance experience
- At least 5 years in a management role
- Experience developing, managing, and maintaining Quality systems for medical devices in development and commercial stages
- Experience with combination products
- Experience implementing Quality systems at virtual organizations
- 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
- 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)
- 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
- 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)
Desired Qualifications
- Advanced degree
- Experience with combination products
- Experience with Veeva QMS
- Experience engaging vendors and CMOs, including relationship management and performance monitoring
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