QA Manager
Peachtree BioResearch Solutions
full-time
Posted on:
Location Type: Remote
Location: Remote • 🇺🇸 United States
Visit company websiteJob Level
SeniorLead
Tech Stack
Google Cloud Platform
About the role
- Initiates and executes internal, site and vendor audits and assessments to assess quality standards, and creates Annual Audit Program
- Provides QA advice on complex procedures to Clinical staff
- Performs quality review of QMS documents
- Responsible for testing and assessing the quality objectives
- Identifies need for project-specific QAMPs, creates, maintains and executes QAMPs and coordinates updates of QAMPs
- Mentor for new QA staff
- Identifies improvement possibilities for continuous development of Julius clinical and initiates and executes project teams working on improvements to processes
- Initiates and executes implementation of new regulations within company
- Collects and interprets data on quality of study conduct and identifies points that require improvement on the basis of the data; Initiates and creates annual department reports
- Is responsible for the application of new quality technologies and methods
- Coordinates and hosts sponsor audits and regulatory inspections
- Coordinates and maintains the CAPA Program
- Assists Global Director Quality Management
Requirements
- Bachelor’s degree in a science, technology, or related field
- Extensive knowledge of legislation and regulations, clinical processes, industry practices and ICH-GCP guidelines
- 7+ years' experience in a relevant function in clinical research, or a minimum of 5 years’ experience in QA
- Ability to adjust priorities as needed in a growing global CRO
- Outstanding communication skills.
Benefits
- Medical, Dental, Vision, Life, Disability coverage
- 20 days PTO + PTO rollover + 13 paid holidays
- 401(k)
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
quality management system (QMS)quality assurance (QA)audit executiondata interpretationquality assessmentproject-specific QAMPsCAPA program managementregulatory complianceclinical researchquality technologies
Soft skills
communicationmentoringprioritizationteam coordinationproblem-solvingcontinuous improvementadaptabilityleadershipcollaborationanalytical thinking