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The QA Manager will lead QA activities, conduct audits and assessments, provide guidance, manage QAMPs, mentor staff, and ensure compliance with quality standards.
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
In addition to working with great people on high performing teams, full-time employees receive:
- Medical, Dental, Vision, Life, Disability coverage
- 20 days PTO + PTO rollover + 13 paid holidays
- 401(k)
Top Skills
Ich-Gcp Guidelines
Quality Management Systems (Qms)
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