Status: Consultant (part-time)
Location: Seattle, WA
The Max Foundation is a non-profit global health organization that believes in a world where all people are able to 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. We do this by delivering medication, technology, and services to patients facing cancer and other critical illnesses, focusing our energy on those who no one else is helping. We carry out our work with team members based in Seattle at our headquarters and in many targeted low- and middle-income countries. The Max Foundation has 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: https://www.themaxfoundation.org/.
The Max Foundation seeks a Medical Commodity Quality Assurance Consultant who will work closely with the Senior Supply Chain Manager & VP of Programs to create and implement quality initiatives for all facets of our supply chain operations to support our organizational mission of bringing humanitarian donations to patients in low- and middle-income countries. The QA Consultant will be responsible for providing subject matter expertise, developing & implementing quality initiatives, and reporting on outcomes and results.
We are seeking a part-time consultant (approximately 20 hours per month) for a 6-12 month period.
Scope & Responsibilities:
- Provides technical expertise in Good Distribution Practice (GDP) for pharmaceutical and medical commodities
- Ensures that a quality management system is maintained sufficiently to comply with GDP
- Focuses on the management of authorized activities and the accuracy of quality 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
- Analyzes the management of authorized activities and the accuracy and quality of records
- Ensures that any required training programs are implemented and maintained
- Provides oversight of 3rd party logistics provider complaints relevant to The Max Foundation shipments
- Provides oversight and approval of any deviations reported via the 3rd party logistics provider
- Provides oversight and approval of any change controls impacting the Max Foundation by the 3rd party logistics provider
- Makes recommendations on any subcontracted activities which may impact upon GDP
- Decides on the final disposition of returned, rejected, recalled or falsified products
- Maintaining updated SOPs for all SC processes; suggest process improvements based on expertise
- Reviews and approves distribution complaints reported to The Max Foundation by their 3rd party Logistics provider
- Considers and applies changes to documentation as required including temperature risk assessments where relevant
- Carries out quality audits, as required
We offer compensation commensurate with experience. No relocation provided.
To Apply: Visit our website at: https://www.themaxfoundation.org/careers to apply. Please include resume & cover letter.
The Max Foundation is dedicated to diversity in staff and is an equal opportunity employer.