Quality Assurance Director: Global QMS Leader

Medicines360; San Francisco (CA); Hybrid; USD 150,000 - 190,000; Full time

Job summary

Medicines360 is seeking a Director of Quality Assurance in San Francisco (hybrid) to lead QA and GXP activities for a complex drug-device portfolio. You will oversee the Quality Management System, regulatory readiness, supplier qualification, and audits, ensuring global compliance and product safety across development to post-market stages.

The role requires a senior QA leader with deep knowledge of US FDA regulations and ISO standards, strong collaboration across functions, and the ability to

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 standards of compliance.
• Experience applying risk management principles to decision making.
• Experience engaging vendors and CMOs, including relationship management and performance monitoring.
• Ability to be certified as a Designated Representative for a Wholesaler through the CA State Board of Pharmacy.

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 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 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 manages regulatory inspections and audits.
• Develops and implements strategies for continuous quality improvement to support evolving regulations.
• Provides Quality and CMC guidance during new product due diligence, development, and commercialization.
• Provides Quality guidance for clinical studies to ensure GCP compliance and supplier qualification.
• Performs product release for investigational and commercial distribution.
• Oversees product complaints and post-marketing surveillance reviews.
• Collaborates with Regulatory to develop Quality and CMC content for submissions and regulatory interactions.
• Participates in supply chain planning and distribution activities.
• Monitors impact of new regulatory requirements on the company and QA function.
• Maintains internal standards library and relationships with external partners.

Skills

US FDA regulatory knowledge

Quality management

GXP compliance

Vendor/CMO management

Leadership

Communication skills

Travel availability

Education

Bachelor's degree in a relevant scientific discipline

Advanced degree preferred

Tools

Veeva QMS

Job description

Medicines360 is seeking a Director of Quality Assurance in San Francisco (hybrid) to lead QA and GXP activities for a complex drug-device portfolio. You will oversee the Quality Management System, regulatory readiness, supplier qualification, and audits, ensuring global compliance and product safety across development to post-market stages.

The role requires a senior QA leader with deep knowledge of US FDA regulations and ISO standards, strong collaboration across functions, and the ability to