About this opportunity:

The Supplier Quality Specialist III/IV plays an integral role in supporting quality activities related to Supplier Management in accordance with FDA, ISO, and other IVD regulations. This individual also supports the company’s quality system activities that comply with the FDA’s Quality System Regulation 21 CFR § 820 and ISO 13485 as well as CLIA, CAP, and applicable state requirements. In this role you will facilitate the supplier compliance program (external audits, drive improvement in supplier performance, supplier development, supplier selection and qualification). In addition, this role will support the quality assurance activities in partner development as needed. 

What you’ll do:

• Maintain the approved supplier list and supplier audit schedule
• Drive compliance with applicable quality management system requirements, engaging in supplier corrective actions as needed
• Conduct external and internal quality audits to identify potential areas of risks and drive continuous improvement
  
• Lead establishing quality agreements with critical suppliers, and quality of supplier records
  
• Actively participate in supplier quality related communication and feedback.
  
• Lead the processing of supplier change notifications 
  
• Engage directly with Freenome suppliers to drive quality and process improvements in order to continuously improve the quality of product and services received
  
• Maintain supplier non-conformances to closure and effectiveness review, working with impacted departments
  
• Maintain organized records that demonstrate compliance to all company processes, regulations, and the company’s QMS
  
• Support routine Quality processes such as document control, employee training, investigating non-conformances, quality metrics, etc.

Must haves:

• Minimum of a Bachelor's degree in a life science field (genetics or molecular biology preferred) or equivalent experience
  
• 5+ years of experience in manufacturing operations, clinical laboratory operations, quality, or supplier quality
  
• ISO 13485 certified Lead Auditor or Certified Quality Auditor (CQA)
  
• Effective problem solving skills and ability to identify, analyze and solve problems with minimal direction and escalate concerns to management
  
• Proficiency in Word, Excel, PowerPoint or Google Workspace and experience with document management systems and document sharing systems
  
• Ability to prioritize and multitask while maintaining a positive and collaborative attitude
  
• Experience with both internal audits or external audits
  
• Effective verbal and written communication skills and ability to share and receive information from all levels of the organization throughout various departments
  
• Excellent teamwork skills and the ability to interface effectively with a wide range of stakeholders
  
• Flexibility to successfully balance and prioritize multiple ongoing projects/tasks in a fast-paced, deadline driven environment
  
• Drive for results and continual improvement
  
• Travel 10 - 30% domestically and potentially internationally, potentially more as needed
  

Nice to haves:

• Certified Quality Engineer, CQE (ASQ)
• Experience in quality system methodologies including but not limited to CAPA, Lean, 5 Why's, Pareto Analysis, Six Sigma
• Experience with statistical process control (SPC) techniques to evaluate and improve process performance
• Experience with process validations
  

Additional information:

Contractors may be hired through a third-party provider and will be considered contingent workers. We invite you to check out our career page @ freenome.com/job-openings/ for additional company information.  

Freenome is proud to be an equal opportunity employer and we value diversity. Freenome does not discriminate on the basis of race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local law.

Applicants have rights under Federal Employment Laws.  

• Family & Medical Leave Act (FMLA)
• Equal Employment Opportunity (EEO)
• Employee Polygraph Protection Act (EPPA)

#LI-HYBRID

The mission of Speechify is to make sure that reading is never a barrier to learning.

Over 50 million people use Speechify’s text-to-speech products to turn whatever they’re reading – PDFs, books, Google Docs, news articles, websites – into audio, so they can read faster, read more, and remember more. Speechify’s text-to-speech reading products include its iOS app, Android App, Mac App, Chrome Extension, and Web App. Google recently named Speechify the Chrome Extension of the Year and Apple named Speechify its Design award winner for inclusivity for 2025.

Today, nearly 200 people around the globe work on Speechify in a 100% distributed setting – Speechify has no office. These include frontend and backend engineers, AI research scientists, and others from Amazon, Microsoft, and Google, leading PhD programs like Stanford, high growth startups like Stripe, Vercel, Bolt, and many founders of their own companies.

Overview

With the growth of our Android app, being the most used text-to-speech app in the Play Store, we find the need for a Senior Android Engineer to help us support the new user base as well as work on new and exciting projects to push us forward.   

This is a key role and ideal for someone who thinks strategically, enjoys fast-paced environments, passionate about making product decisions, and has experience building great user experiences that delight users.

We are a flat organization that allows anyone to become a leader by showing excellent technical skills and delivering results consistently and fast. Work ethic, solid communication skills, and obsession with winning are paramount. 

Our interview process involves several technical interviews and we aim to complete them within 1 week. 

What You’ll Do

• Owning major features and working closely with our design team - take ownership of features inside the app and become responsible of delivering high quality features
• Shape the future of our Android team
• Own, maintain and improve reliability metrics for key features
• Participate in discussions across different teams - Product, Design, Engineering
• Review pull requests, and support other teammates
• Handle critical issues or cope with unexpected challenges 
• Take ownership of feature releases and provide nightly builds for the QA team

An Ideal Candidate Should Have

• 5+ years of software engineering experience
• Familiarity with Android components
• Experience building or contributing to at least one Android app
• Product design intuition and user empathy
• Drive to push the boundaries of Android UI/UX
• Understanding of the importance of tests and how to approach writing tests
• Self-drive to improve the app and codebase above and beyond what's outlined in the spec
• Rock solid experience with Kotlin, Kotlin Coroutines, Kotlin Flow, Dagger 2, MVVM, Clean Architecture, Background Services, Music Player Service, Android Animations, Jetpack Navigation, JUnit tests
• Excellent communication skills
• User oriented problem solving approach
• Driven with continuous feedback from leaders

Bonus:

• Experience building, maintaining, or otherwise contributing to open source projects in Android
• Experience with iOS, Web or NodeJS

Technologies we use:

• Kotlin
• Kotlin Coroutines
• Kotlin Flow
• Jetpack Navigation
• Dagger 2
• Room
• Custom Views, Canvas & Paint
• Jetpack Compose
• JUnit

What We offer:

• A fast-growing environment where you can help shape the company and product.
• An entrepreneurial-minded team that supports risk, intuition, and hustle.
• A hands-off management approach so you can focus and do your best work.
• An opportunity to make a big impact in a transformative industry.
• Competitive salaries, a friendly and laid-back atmosphere, and a commitment to building a great asynchronous culture.
• Opportunity to work on a life-changing product that millions of people use.
• Build products that directly impact and support people with learning differences like dyslexia, ADD, low vision, concussions, autism, and more.
• Work in one of the fastest growing sectors of tech, the intersection of artificial intelligence and audio.

Think you’re a good fit for this job? 

Tell us more about yourself and why you're interested in the role when you apply.
And don’t forget to include links to your portfolio and LinkedIn.

Not looking but know someone who would make a great fit? 

Refer them! 

Speechify is committed to a diverse and inclusive workplace. 

Speechify does not discriminate on the basis of race, national origin, gender, gender identity, sexual orientation, protected veteran status, disability, age, or other legally protected status.

Position Summary:

The Associate Director, GxP Systems will report to the Sr. Director, Commercialization Systems and will be responsible for leading the implementation, validation, and support of GxP-regulated systems to enable Quality Assurance, Regulatory, Clinical, and Process Development & Manufacturing (PD&M) in a commercial biotech environment. This role will play a pivotal part in supporting regulatory, compliance, and for commercialization. Working with Quality Assurance, Medical Affairs, Regulatory Affairs, Clinical Operations, and PD&M functions to ensure systems are fit-for-purpose, validated and aligned with evolving business requirements.

Responsibilities:

• Serve as the System Owner and hands-on administrator for GxP systems (e.g., TraceLink, Lorenz DocuBridge, Egnyte Life Sciences, ZenQMS, Global Vision, Veeva), overseeing system lifecycle, performance, and compliance
• Participate in system implementation activities, including vendor selection, requirements gathering, testing, and deployment to ensure alignment with business and regulatory needs
• Provide oversight and direction for Computer System Validation (CSV) activities and validation documentation, partnering with the Validation Engineer to ensure regulatory compliance and audit readiness
• Own and lead Change Control processes for all GxP systems, including impact assessments, risk evaluations, documentation, coordination of testing, and release management
• Perform system administration activities, including user access provisioning, role management, periodic access reviews, and audit trail monitoring
• Oversee system maintenance, enhancements, and issue resolution (e.g., upgrades, patches, changes), ensuring appropriate validation impact assessments, documentation updates, and minimal business disruption
• Collaborate with IT and vendors to support integration, system performance optimization, and resolution of technical issues
• Develop and maintain system-related documentation, including SOPs, Systems Inventory, administrative procedures, and work instructions in collaboration with Quality Assurance and business stakeholders
• Provide SME support during FDA audits and inspections, including preparation, documentation review, and representation of system controls and validation status
• Drive continuous improvement by identifying gaps, inefficiencies, and opportunities for system scalability and automation
• Translate business requirements into effective system solutions, acting as a key liaison between business stakeholders and technical teams
• Manage project timelines, risks, and deliverables to ensure successful and compliant execution of system initiatives

Qualifications:

• Bachelor’s degree in Life Sciences, Information Systems, Computer Science, Engineering, or a related field; advanced degree preferred
• 10-12 years of hands-on experience with GxP systems in Life Sciences, including system administration, validation oversight, and operational support
• Proven experience implementing and validating systems such as eQMS, TraceLink, LMS, Validated Documents and Data storage solutions (such as Box for GxP or Egnyte Life Sciences), or ERP systems (e.g., NetSuite, Oracle, SAP) in a GxP-regulated environment
• Strong understanding of CSV, data integrity, Part 11 compliance, and regulatory expectations (FDA, EMA, ICH)
• Experience partnering with validation/CSV resources while maintaining accountability for system compliance and validation outcomes
• Proven experience owning and managing Change Control processes for GxP systems
• Experience supporting pre-commercial biotech organizations transitioning to commercialization
• Ability to balance strategic oversight with hands-on system administration and operational responsibilities
• Strong cross-functional collaboration skills across IT, QA, Regulatory, and Technical Operations
• Experience managing vendors and implementation partners
• Excellent troubleshooting, analytical, and problem-solving skills
• Strong communication skills with the ability to translate technical concepts into business terms and influence stakeholders