Director of Quality Assurance

Medicines360•San Francisco, CA

2d•$200,000 - $215,000•Hybrid

About The Position

At Medicines360, 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 Medicines360, please visit Medicines360.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 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.

Requirements

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

Nice To Haves

advanced degree is preferred
experience with combination products is desired
Experience with Veeva QMS is preferred

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.