About
We are a clinical-stage biopharmaceutical company focused on developing treatments for multidrug-resistant bacterial infections and rare diseases. We are looking for a Clinical Compliance consultant to oversee & direct inspection readiness strategy & activities for GCP and clinical supply management in preparation for our NDA submission later this year. This consultant will be responsible for partnering with key stakeholders across the clinical development organization on audit planning and reporting, ensuring transparent collaborative engagement in addressing clinical audit observations and supporting quality risk management activities. This consultant will help develop strategic GCP objectives and overseeing tactical execution for inspection readiness including a mock audit. This consultant should have recent experience in successfully leading inspection readiness activities for an NDA submission.
Responsibilities
- Partner with key stakeholders across the clinical development organization as the clinical compliance lead and oversee the inspection readiness strategy & activities for GCP and clinical supply management in preparation for our NDA submission later this year
- Develop strategic GCP objectives and oversee tactical execution for inspection readiness including a mock audit
Ideal Candidate
Skills
Functional Areas
Quality Assurance / Control (QA/QC)
Therapeutic Areas
Infectious Disease
Product Technologies
Drug
Development Phases
III/Pivotal
Regulatory Pathways
NDA
Qualifications
Education
- BS (Bachelor of Science)