Global Quality Assurance, Healthcare Regulatory Affairs - Zipline

Do you want to change the world? Zipline uses drones to deliver critical and life-saving medicine to thousands of hospitals serving millions of people in multiple countries. Our mission is to provide every human on Earth with instant access to vital medical supplies. Join Zipline and help us make this a reality for billions of people.

ABOUT YOU AND THE ROLE

As a member of Zipline’s Global Quality team, you’ll be responsible for helping Zipline to promote Healthcare Quality by driving or coordinating initiatives that ensure compliance with all Healthcare Standards internally (self-inspections) and externally (interactions with Regulators or Clients; external audits, etc).

WHAT YOU'LL DO

By joining us, you will therefore be contributing to our mission of ensuring that every human on Earth has instant access to vital medical supplies. Your main responsibilities will include:

Regulatory Compliance & External Audits

• Ensuring all nests are in compliance with all Healthcare Regulatory Standards (FDA, etc).
• Maintaining a master tracker of all regulatory requirements per nests & audits.
• Compiling and preparing materials for submission to regulatory agencies for both new and existing countries.
• Attending all External Audits.
• Ensuring all results are formally reviewed internally with Ops & GMs.
• Ensuring all local, State and National Regulatory licensing and registration renewals and Import/Export Permits are completed.
• Deploying quality training to local employees.

Self-Inspections

• Creating the processes for self-inspections.
• Coordinating & executing self-inspections at each nest (minimum 1 per year at each nest).
• Ensuring all corrective and preventive actions are closed out.
• Ensuring all results are formally reviewed internally with the Operations team & General Manager(s).

Proactive Quality Initiatives

• Gathering information and informing Zipline on industry intelligence through regulatory agency interactions and research to properly adjust compliance activities at Zipline.
• Developing systems for in-housing verification of compliance.
• Managing any recalls and organizing mock recalls.
• Improving the health of Zipline Quality Systems by inviting external experts from industry.
• Leading the company to acquire International Quality Certifications (e.g. ISO Certifications, etc) to boost the Zipline Quality Brand.
• Conducting Quality Risk Assessment to prompt the company of potential risks to our Quality Culture.
• Creating new standards for drone-based distribution. Eg. Packaging Credentials
• Working closely with Operations to resolve in-house and supplier quality problems using established problem solving methodologies (Root Cause Analysis, Mistake-Proofing, etc).

Other Responsibilities:

Assisting the Healthcare Quality Team is any capacity as needed.

WHAT YOU'LL BRING 

• Bachelors in Physical Sciences (Biochemistry, Chemistry, Microbiology, Pharmacy, etc.), Engineering (Chemical, Biochemical, Biological, Process Engineering, etc), Biotechnology, etc. Master’s level in Quality Management and other relevant fields will be an added advantage.
• 3 – 5 years direct experience in a Quality Assurance role in the Manufacturing/ Regulatory/ Pharmaceutical/Food environment.
• Experience as a Certified Auditor
• Experience in GDP, GMP, or ISO environments
• Global/ international regulatory experience will be an added advantage.

WHAT ELSE YOU NEED TO KNOW

• Must have the ability to interpret regulatory standards, guidance, and laws.
• Must have excellent oral and written communication skills
• Must have the ability to pay excellent attention to detail.
• Must be process-oriented thinker
• Must be conscientious
• Must be a highly motivated quality culture pillar (someone who wants to aspire to do more)

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, please apply!