Quality Assurance – Regional
Do you want to change the world? Zipline uses drones to deliver critical and lifesaving 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
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
- Develop content and revise SOPs, policies, manuals, protocol, contracts, work instructions, checklist, templates, forms, etc.
- Work closely with Zipline Academy to ensure all SOPs are accurately and effectively represented in our training & certification strategy.
- Define the terminology used in documentation so they are clearly understood by all audiences that read and/or use them.
- Lead all staff or peer review processes to improve the quality of documentation.
Process Improvement & Championing Quality Culture
- Work closely with team members or Subject Matter Experts (SMEs) to develop and improve processes for new and existing Distribution Centers (DCs).
- Work with a software team to develop SOP-related automation.
- Develop processes for new use cases in new countries.
- Spearhead opportunities that will improve product quality outcomes.
- Support the teams and work with them (as a peer) to improve understanding of quality and quality adherence (not just call out problems but also fix them)
- Develop and maintain an effective documentation management system such that documents are easily organized, accessed, distributed, archived, etc.
- Manage all aspects of the documentation approval process.
- Ensure excellent management of records (eg. Training compliance records, etc).
- Promote Good Documentation Practices within Zipline.
Regulatory Compliance & External Audits
- Ensure all nests are in compliance with all Healthcare Regulatory Standards (FDA, etc).
- 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.
- Attend all External Audits.
- Ensuring all results are formally reviewed internally with Ops & GMs.
- Ensure all local, State and National Regulatory licensing and registration renewals and Import/Export Permits are completed.
- Deploy quality training to local employees.
- Creating the processes for self-inspections.
- Coordinate & execute self-inspections at each nest
- Ensure all CAPAs are closed out.
- Ensuring all results are formally reviewed internally with Ops & GMs .
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.
- Improve the health of Zipline Quality Systems by inviting external experts from industry.
- Lead 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
- Work closely with Operations to resolve in-house and supplier quality problems using established problem solving methodologies (Root Cause Analysis, Mistake-Proofing, etc).
Global Quality Support
- Working with all other regional QAs to ensure we have global consistency where it matters and are only created local deviations when necessary
- Supporting various Global Quality projects as needed
What You’ll Bring
Bachelors in Biochemistry, Chemistry, Microbiology, Pharmacy, etc., Engineering (Chemical, Biochemical, Biological, Process Engineering, etc), Biotechnology, etc
Master’s level education in Pharmacy, Biochemistry, Chemistry, Microbiology, etc., Engineering (Chemical, Biochemical, Biological, Process Engineering, etc), Biotechnology, Quality Management, etc.
- 3 – 5 years direct experience in a Quality Assurance role in the Pharmaceutical/Manufacturing/Regulatory environment.
- Experience in GDP, GMP, or ISO environments
- 5+ in a top-notch Pharmaceutical/Food/ Regulatory Institutions.
- Certified Auditor
- Global/ international regulatory experience.
Basic Understanding of Quality
Ability to interpret regulatory standards, guidance, and laws.
Good at working with stakeholders
- Would trust them to own these relationships fully
- Knows what regulators care about
Excellent oral and written communication skills.
Can write legible SOPs
- Can keep track of all of the dates, milestones etc.
- Can keep all their documentation organized
Excellent attention to detail.
- Has a great eye for potential quality defects or mistakes
- Will be very good at auditing (holds a high bar)
Problem Solver & Servant Leader
- Will roll up their sleeves and work with the team to fix issues (not just identify problems). Feel like a team member (not a superior) to the ops team.
- Will they make trade-offs — Have to be practical.
- Process-oriented thinker– can they offer good and creative solutions.
Grit & Drive
- Is going to be fast at delivering AND have a high quality bar for their work
- Is not going to be demoralized easily when there are roadblocks
- Highly motivated quality culture pillar (someone who wants to aspire to do more).
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, ancestry, national origin, religion or religious creed, mental or physical disability, medical condition, genetic information, sex (including pregnancy, childbirth, and related medical conditions), sexual orientation, gender identity, gender expression, age, marital status, military or veteran status, citizenship, or other characteristics protected by state, federal or local law or our other policies.
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!
HOW TO APPLY
CLICK HERE TO READ MORE AND APPLY
CLOSING DATE : ONGOING
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