Peachtree BioResearch Solutions a Julius Clinical Company · 20 hours ago
QA Manager
United States
Full-time
Remote
Senior Level
5+ years expPeachtree BioResearch Solutions, a Julius Clinical Company, is a global specialized full-service CRO providing highly specialized study operations teams for pharmaceutical, biotech, and medical device companies. They are looking to hire a Quality Assurance Manager who will lead QA activities in the US, ensuring compliance with quality standards and regulations while mentoring new QA staff and driving continuous improvement initiatives.
Health CarePharmaceuticalService Industry
Responsibilities
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
Qualification
Required
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)
Company
Peachtree BioResearch Solutions a Julius Clinical Company
Over 15 years ago, Peachtree was founded to fill a perceived missing principle in typical CRO services.
201-500 employees
Funding
Current Stage
Growth StageTotal Funding
unknown2025-05-14Acquired
Leadership Team
Sharon Billie Hilton
Co-Founder & Executive Vice President
Recent News
2025-05-17
Company data provided by crunchbase