Quality Assurance Officer - Regional at Zipline

About You and The Role  

• It is our mission to build a world-class quality healthcare process 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
Content Development:

• 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 automations.
• 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)

Document Management:

• 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 (e.g. 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 relevant stakeholders.
• Ensure all local, State and National Regulatory licensing and registration renewals and Import/Export Permits are completed.
• Deploy quality training to local employees.

Self-Inspections:

• Creating the processes for self-inspections.
• Coordinate & execute self-inspections at each nest
• Ensure all corrective and preventive actions are closed out.
• Ensuring all results are formally reviewed internally with relevant stakeholders .

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. E.g. 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 Quality Assurance team members 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
Education:

• Bachelor's or Master's Degree in Biochemistry, Chemistry, Microbiology, Pharmacy, Quality Assurance, Engineering (Chemical, Biochemical, Biological, Process Engineering, etc), Biotechnology, etc.

Career:

• 3 - 5 years direct experience in a Quality Assurance role in the Pharmaceutical/Manufacturing/Regulatory environment
• Experience in GDP, GMP, or ISO environments
• Certified Auditor
• Global/ international regulatory experience.

Skills / Competencies:

• Basic Understanding of Quality: Ability to interpret regulatory standards, guidance, and laws.
• Good at working with stakeholders: Ability to build relationships with relevant stakeholders and know what regulators care about
• Excellent oral and written communication skills:  Ability to write legible SOPs
• Organized: Ability to keep track of all of the dates, milestones etc. and can keep all documentation organized
• Excellent attention to detail: Ability to detect potential quality defects or mistakes and good at auditing
• Problem Solver & Servant Leader: Ability to identify issues, create solutions and work with the team to fix those problems 
• Grit & Drive: Willingness to aspire to do more so far as quality is concerned