Manager/Sr. Manager Clinical QA
Focusing on Commercialization, Discovery, and Development of pathbreaking medicines, the Manager/Sr. Manager Clinical QA will provide auditing support on a global level to bring breakthrough medicines for patients. Are you ready to join an organization and make a universal impact?
- GCP oversight of Clinical Operations.
- Take charge of audits of CROs, Clinical Submission Documents, & Clinical Investigation Sites.
- Stay on top of FDA, ICH GCP guidelines for management of clinical trials within US & EU.
- Revise and Review QA SOPs.
- Support Quality Management and Quality Improvement plans for QA.
- Conduct GCP training.
- Support regulatory inspections including pre-inspection audits.
- Other duties as assigned.
- Bachelor's degree
- 5+ years in pharma/biopharama in a GCP role.
- 3+ years performing GCP CRO audits.
- Regulatory inspection experience.
- Able to travel as needed.