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Quality Assurance Consultant

About the Role

Foundation Overview:

The Max Foundation is a fast-growing, ambitious, and deeply mission-driven non-profit global health organization that believes in a world where all people can access high impact medicines, where geography is not destiny, and where everyone can strive for health with dignity and with hope. We exist to accelerate health equity, operating with a human approach in every aspect of the work. We do this by delivering medication, technology, and services to individual patients facing cancer and other critical illnesses, focusing our energy on those who no one else is helping. We carry out our work by collaborating with team members at our headquarters based in Seattle as well as several low- and middle-income countries. We forge strong collaborations with likeminded individuals representing global health, medicine and health care, industry, and those committed to our mission and values. The Max Foundation offers a full range of programs and services, all focused on serving marginalized people living with cancer and other critical illnesses around the world. Learn more about The Max Foundation:


The Max Foundation seeks a Quality Assurance Consultant who will work closely with the VP of Program Operations & Director of Global Supply Chain to create and implement quality initiatives for all facets of our supply chain operations in support of our organizational mission to accelerate health equity. The QA Consultant will be responsible for providing subject matter expertise, developing & implementing quality initiatives, and reporting on outcomes and results.

Scope & Responsibilities:

Further develops and maintains Max’s Quality Management System (QMS)
Provides technical expertise in Good Distribution Practice (GDP)
Offers leadership and subject matter guidance to maintain quality management system in compliance with GDP requirements
Analyzes the management of authorized activities and ensures the accuracy and quality of records; Knowledge of and compliance with EU Guidelines on Good Distribution Practice of Medicinal products for Human Use (2013/C 343/01)
Establishing necessary Quality Agreements with drug product donors, as needed
Ensures that any required training programs are implemented and maintained
Oversees 3rd party logistics provider feedback relevant to The Max Foundation shipments
Reviews and approves distribution complaints reported to The Max Foundation by 3rd party logistics provider
Provides oversight and approval of any deviations or escalations reported via the 3rd party logistics provider
Understand the impact and provide approval for any change controls impacting The Max Foundation (ex. inventory storage, etc.) by the 3rd party logistics provider
Makes recommendations on any subcontracted activities which may impact upon GDP
Responsible for final disposition and required documentation of returned, rejected, recalled, or falsified products
Maintains updated SOPs for all SC processes; suggest process improvements based on expertise
Reviews and updates quality and supply chain documentation, as required, including temperature risk assessments where relevant
Leads, participates in, and supports quality audits, as required at 3PL sites; (may require occasional travel)

Required Proficiencies & Experience:

10+ years of experience working with pharmaceutical manufacturing & distribution
Proven experience in implementation & management of Quality Management Systems
Experience with deviation management, root cause analysis, audit management, CAPA, quality risk management, & mitigation plans
Experience with management of audit findings, including results monitoring for remediation
Six Sigma Green/Black Belt certification, highly desirable

Skills and Attributes:

Passionate about The Max Foundation’s mission and vision, and determined to lead and accomplish all goals related to current and future strategic plans
High attention to detail and a high standard for quality work product
Understanding of and comfortable in a global environment, with an emphasis on low and middle-income countries
Passion for exceptional collaboration, and flexibility to do what it takes to elevate positive culture
Comfort working in a complex, fast-paced, and high-workload environment
Caring, humble, and people-oriented servant leader
Resourceful, finds solutions using all available data to overcome challenges impacting the organization

To Apply: Visit our website at to apply. Please include a resume and cover letter.

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