- Opportunity to develop the Clinical Quality Function on the QA Team
- Join a clinical stage biotech company with wide pipelines
About Our Client
Our client is an exciting and disruptive clinical stage biotech company with a wide pipeline focused on developing treatments for inflammatory conditions, cancers, and respiratory and lymphatic diseases, among others.
MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.
- Represent QA and provide QA guidance for project/study team with participation in providing GCP compliance input and guidance to Clinical Operations
- Interface with relevant stakeholders, including Regulatory, Clinical and Development sub-team
- Develop, implement and execute the audit strategy and plan for clinical programs
- Conduct external GCP audits
- Participates in the development of the GCP Quality Management Systems
- Implement internal GCP compliance audit and inspection readiness strategy
- Provides GCP training and Mock Inspection preparation support as needed
- Promotes the GCP Compliance across the organization
The Successful Applicant
- BS/BA degree in a scientific discipline or equivalent qualifications
- Minimum 10 years of increasing experience in GCP and PV QA role
- Comprehensive working knowledge of GCP related regulatory requirements US FDA, EU Directives and ICH guidelines and Pharmacovigilance (PV) regulatory guidance.
- Auditor training or certification
- Experience working in a clinical operations function
What's on Offer
- Highly competitive base salary and benefit package
- Opportunity to own Clinical quality function at rapidly growing organization
- Career growth and professional development
- Opportunity to work fully remote