Quality and Compliance Specialist
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.
Note: Reify 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.
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