Peachtree 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. Formed over 15 years ago by a pharma leadership team experienced in buying CRO services with the purpose of creating trusting partnerships with sponsor clients - no matter their budget. We do this by investing in people who thrive in an environment where their experience and contributions can be felt throughout the organization. It's an exciting time as we expand our global reach, while still offering a personalized approach to sponsors and delivering incredible value.
We are looking to hire a Quality Assurance Manager to who will lead QA activities in the US.
Some 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
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
- Medical, Dental, Vision, Life, Disability coverage
- 20 days PTO + PTO rollover + 13 paid holidays
- 401(k)
Top Skills
What We Do
Over 10 years ago, Peachtree was founded to fill a perceived missing principle in typical CRO services. Where can I find a CRO that will partner with me, understand my challenges, and solve issues to keep my program on track? Filling this need requires experienced clinical research professionals.
We focused on people – building an organization by investing in highly experienced personnel with broad therapeutic area expertise in a number of clinical trials. From single-center Phase I to global multi-center trials. Most all of our clinical personnel have both sponsor and CRO experience – allowing us
to fully understand the issues our sponsor-clients face. We built a rock-solid processes and systems infrastructure to support the teams and this investment continues today – always seeking to improve our service.
We also saw the opportunity to support an under-served segment of the market – emerging mid-sized companies. We felt they could benefit from access to highly-experienced teams that understand the challenges of limited resources and be flexible, reliable, and responsive. Most of all – provide solutions.
So where is Peachtree today?
A full-service CRO offering project management, feasibility & subject recruitment, clinical site management & monitoring, data management, biostatistics, medical monitoring, medical writing, and
clinical quality assurance
We are 80+ highly-experienced clinical research professionals with an average of more than 20 years relevant clinical experience
Our client roster continues to grow having worked with nearly 100 pharmaceutical, biotech, and medical device companies providing full-service clinical trial support to niche services
Continued investment in best-in-class systems such as IBM Clinical for EDC, Veeva Vault for eTMF, ZenQMS for quality management and training, and Oracle for CTMS
