Director of Quality Assurance

ABOUT MEDICINES
360

At Medicines
360, we are more than a women’s health innovation organization — we are a catalyst for change. We are fearless in our pursuit of creative approaches to solving consequential women’s health issues and transforming novel ideas into life-changing products that improve the lives of all women, and especially the underserved. We are fiercely dedicated to our mission of improving women’s health worldwide.

Our launched products address pressing health concerns of women, providing them with the products they need to live healthier, more fulfilled lives. For more information on Medicines
360, please visit Medicines
360.org

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

The Director of Quality Assurance provides strategic and operational leadership for the Quality and GXP activities of Medicines
360 and its affiliates. Medicines
360 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 Medicines
360 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 Medicines
360 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 life cycles.

• 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 Medicines
  360 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…