Quality Assurance, Rwanda
Do you want to change the world? Zipline is on a mission to transform the way goods move. Our aim is to solve the world’s most urgent and complex access challenges by building, manufacturing and operating the first instant delivery and logistics system that serves all humans equally, wherever they are. From powering Rwanda’s national blood delivery network and Ghana’s COVID-19 vaccine distribution, to providing on-demand home delivery for Walmart, to enabling healthcare providers to bring care directly to U.S. homes, we are transforming the way things move for businesses, governments and consumers.
The technology is complex but the idea is simple: a teleportation service that delivers what you need, when you need it. Through our technology that includes robotics and autonomy, we are decarbonizing delivery, decreasing road congestion, and reducing fossil fuel consumption and air pollution, while providing equitable access to billions of people and building a more resilient global supply chain.
About You and The Role
Zipline believes access to medical care should not depend on your GPS coordinates. We are at the forefront of a logistics revolution, using autonomous aircraft to deliver just-in-time, lifesaving medical supplies on 3 continents around the world right now, 7 days a week. Are you interested in building a system that 200 million people will depend on with their lives?
It is our mission to build a world-class healthcare quality at Zipline. We are looking for an enthusiastic professional with a proven track record of going above and beyond with responsibilities pertaining to Quality. Delivering innovative ideas to proactively achieve compliance and actively engaging with internal and external stakeholders effectively is key to helping Zipline attain the highest quality bar.
What You'll Do
Regulatory Compliance & External Audits
- Ensure existing and new nests are in compliance with all Healthcare Regulatory Standards (FDA, etc) at all times.
- Maintain a master tracker of all regulatory requirements per nests & audits.
- Compile and prepare materials for submission to regulatory agencies for both new and existing countries.
- Lead, empower and prep all leads/key operators to run External Audits.
- Ensure all local, State and National Regulatory licensing and registration renewals and Import/Export Permits are completed.
- Deploy quality training to local employees.
- Manage all recalls and organizing mock recalls.
Self-inspection Program and Fulfillment Operations Assessments
- Develop systems for in-housing verification of compliance.
- Create / Develop Fulfillment Operations Assessments Program
- Lead and manage Internal Audit Programs
Document Management & Content Development
- Maintaining all existing documentation / SOPs + creating new SOPs/documentation for new use cases and new country launches and new supplier/vendors.
- Develop content and revise SOPs, policies, manuals, protocol, contracts, work instructions, checklist, templates, forms, etc.
- Develop and maintain an effective documentation management system such that documents are easily organized, accessed, distributed, archived, etc.
What You'll Bring
- Minimum: Bachelors degree in Biochemistry, Chemistry, Microbiology, Pharmacy or Engineering. Preferred:Master’s degree in one or more of the above fields. management, etc.
- 3 – 5 years direct experience in Quality Assurance, Quality Control, or Fulfillment Operations in the Pharmaceutical / Manufacturing / Regulatory environment.Experience in GDP, GMP, or ISO environments
- Experience working with Enterprise Resource Planning software (ERPs) such as Oracle, SAP, ODOO, etc.
- Demonstrated communication, leadership, and problem-solving skills, with demonstrated ability to manage multiple priorities simultaneously.
- Ability to write, speak, and present effectively and persuasively at all levels.
- Strong analytical and organizational skills; ability to achieve success in situations with high degrees of uncertainty and complexity.
- Self-driven, results-oriented, and an authentic desire to take on increased scope and responsibility.
- Attraction to mentoring and training. Ensuring that Quality is a primary focus at all Nests comes from your ability to inspire
- Can be based anywhere in Rwanda. Role requires up to ~75% presence at either of the two DCs, as well as 10% international travel.
- Must have legal right to work in Rwanda.
WHAT ELSE YOU NEED TO KNOW
Zipline is an equal opportunity employer and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws or our own sensibilities.
We value diversity at Zipline and welcome applications from those who are traditionally underrepresented in tech. If you like the sound of this position but are not sure if you are the perfect fit, please apply!