Quality and Compliance Specialist at Reify Health

Sorry, this job was removed at 6:35 p.m. (CST) on Saturday, June 18, 2022
Find out who’s hiring remotely Nationwide
See all Remote jobs Nationwide
Easy Apply
By clicking continue you agree to Built In’s Privacy Policy and Terms of Use.

About Us

Reify Health is paving the way to faster, predictable, and more accessible clinical trials. Through its business entities, StudyTeam and Care Access, the company provides best-in-class trial optimization software and transformative clinical trial infrastructure that delivers research directly to more healthcare providers, communities, and patients wherever they are. Through partnerships with top biopharma companies, thousands of research clinics worldwide, and leading healthcare & community organizations, Reify Health is helping bring new medicines to patients faster, one trial at a time.

Reify Health is changing the way medicines are developed by connecting and empowering the clinical trial ecosystem. In this role you will be a member of Reify's Compliance Team and will assist in the implementation and maintenance of the company’s Quality Management program. 

This person will work closely with all of Reify’s departments including engineering, product, and customer success and be responsible for ensuring high quality across different areas. A successful candidate will be an enthusiastic self-starter with hands-on experience implementing and maintaining quality management principles within a global decentralized technology company.

What You’ll Be Working On:
  • Responsible for assisting in the day to day functions and activities of the Quality Management program including document control, quality record review, change control, CAPA, investigations and non-conformances
  • Outlining quality management policies and procedures for the company
  • Interpreting and applying quality management standards across all of Reify’s business functions
  • Supporting external audits
  • Supporting Reify’s internal audit program
  • Overseeing risk management activities
  • Review and approving validation deliverables/documentation during the validation process
  • Working with other departments in investigation of incidents that affect the QMS
  • Investigating and documenting CAPAS and associated RCA
  • Guiding and enhancing the company’s project documentation efforts and deliverables
What You Bring to Reify Health:
  • Bachelor’s degree and at least 4 years in Quality Assurance, Quality Management and Computer System Validation.
  • Experience working in a regulated environment with a strong Quality mindset
  • Ability to communicate Quality standards and requirements to various business stakeholders clearly and effectively
  • Demonstrated knowledge of regulatory requirements and standards including 21 CFR Part 11, Annex 11 and GAMP 5
  • Previous experience in agile SDLC
  • Knowledge in audit fundamentals and the operations of an internal audit program
  • Ability to write policies, SOPs, and other documentation related to the QMS
  • Promotes a Quality culture while encouraging innovation
  • Demonstrated knowledge of ISO 9001 Quality Management
It would be nice if you had:
    • Previous experience in SaaS
    • Knowledge of ICH E6 Good Clinical Practice
    • Previous experience and knowledge of HIPAA regulations and GDPR
    • Previous experience designing and/or providing training on topics related to Quality Management
    • Previous experience with Quality Management software (Veeva, MasterControl etc)

We value diversity and believe the unique contributions each of us brings drives our success. We do not discriminate on the basis of race, sex, religion, color, national origin, gender identity, age, marital status, veteran status, or disability status.

NoteReify Health is unable to sponsor work visas at this time. If you are a non-U.S. resident applicant, please note that Reify works with a Professional Employer Organization.

For a detailed overview of Reify Health's privacy policy, please visit www.reifyhealth.com/privacy-policy.

Read Full Job Description
Easy Apply
By clicking continue you agree to Built In’s Privacy Policy and Terms of Use.

Technology we use

  • Engineering
  • Product
  • Sales & Marketing
    • JavascriptLanguages
    • PythonLanguages
    • TypeScriptLanguages
    • ClojureLanguages
    • EQLLanguages
    • ReactLibraries
    • CircleCIFrameworks
    • AWS (Amazon Web Services)Frameworks
    • ReactFrameworks
    • ReframeFrameworks
    • PostgreSQLDatabases
    • RedshiftDatabases
    • VanillaSQLDatabases
    • Google AnalyticsAnalytics
    • CanvaDesign
    • ConfluenceManagement
    • Google DriveManagement
    • Google DocsManagement
    • Google SlidesManagement
    • JIRAManagement
    • Microsoft ProjectManagement
    • Monday.comManagement
    • SmartsheetManagement
    • TrelloManagement
    • Monday.comManagement
    • HubSpotCRM
    • MailChimpEmail

An Insider's view of Reify Health

How would you describe the company’s work-life balance?

We’re all passionate about the work we’re doing and with that comes trust that everyone is getting their work done, especially when working remotely. However Reify understands there’s more to life than work, and in addition to the several wellness-days offered throughout the year, our flexible PTO policy allows for time off when needed!


Marketing Associate

What does your typical day look like?

My mornings are all about responding to emails and following up with applicants! For myself, I find it to be super important to follow up with applicants asap. After lunch, it's time to get on the phone, follow up with the hiring manager's I support, and partner with teammates on various people/DEI initiatives!


Senior Talent Acquisition Partner, Technology

What makes someone successful on your team?

At Reify, all engineers have a voice in improving the engineering process and the technologies we use. A successful engineer at our company is one who constantly evaluates and learns new frameworks, libraries, and processes that can improve product quality and developer experience. Everyone is empowered to be a change agent and stay curious.


Senior Director, Engineering

How do you make yourself accessible to the rest of the team?

I try to be approachable and work to create an environment where people are comfortable reaching out for updates and support. I practice flexibility and situational leadership as team members have different communication styles and preferences.


Chief Financial Officer

What projects are you most excited about?

The projects that get me excited to come to work each day are those that help our Customer Success team to be more efficient and effective. Our main focus in Operations is to build tools and processes that allow Customer Success to spend their valuable time having meaningful interactions with our users.


Manager, Customer Success Operations

What are Reify Health Perks + Benefits

Friends outside of work
Eat lunch together
Intracompany committees
Daily sync
Team owned deliverables
Team based strategic planning
Group brainstorming sessions
Open office floor plan
Unconscious bias training
Diversity manifesto
Hiring Practices that Promote Diversity
Health Insurance & Wellness Benefits
Flexible Spending Account (FSA)
Dental Benefits
Vision Benefits
Health Insurance Benefits
Life Insurance
Mental Health Benefits
Mental Health Wellness Days Off.
Retirement & Stock Options Benefits
401(K) Matching
Company Equity
Child Care & Parental Leave Benefits
Generous Parental Leave
Flexible Work Schedule
Remote Work Program
Family Medical Leave
Vacation & Time Off Benefits
Generous PTO
Paid Holidays
Paid Sick Days
Perks & Discounts
Casual Dress
Company Outings
Happy Hours
Home Office Stipend for Remote Employees
Professional Development Benefits
Job Training & Conferences
Diversity Program
Lunch and learns
Cross functional training encouraged
Promote from within
Time allotted for learning
Customized development tracks

More Jobs at Reify Health

Easy Apply
By clicking continue you agree to Built In’s Privacy Policy and Terms of Use.
Save jobView Reify Health's full profileSee more Reify Health jobs