QA Manager

Job not on LinkedIn

November 20

Apply Now

Receive Emails with Similar Jobs

Peachtree BioResearch Solutions

WebsiteLinkedInAll Job Openings

Biotechnology • Pharmaceuticals • Science

Peachtree BioResearch Solutions is a full-service Clinical Research Organization based in the United States. The company focuses on providing a solutions-based approach to small and mid-size sponsors by offering a range of services including site management, clinical monitoring, study feasibility, data management, biostatistics, project management, quality assurance, and medical writing and monitoring. Peachtree emphasizes flexibility, scalability, and reliability in its services, with experienced staff in biostatistics, data integrity, and medical trial management.

51 - 200 employees

Founded 2013

🧬 Biotechnology

💊 Pharmaceuticals

🔬 Science

📋 Description

• 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)