Remote QA Manager, Clinical Compliance & Audits

InClin; San Mateo (CA); On-site; USD 109,000 - 136,000; Full time

Benefits offered by this job

401K

Paid Time Off

Health Insurance

Vision Insurance

Dental Insurance

Job summary

InClin, Inc. is seeking a highly skilled Quality Assurance Manager to join our team in a fully remote capacity. You will oversee QA activities, lead audits, manage the eQMS, CAPAs, and ensure GCP compliance from your home office.

Reporting to the Director of Quality, you will drive continuous improvement, review deviations, conduct risk assessments, and support regulatory inspections. Travel up to ~25% may be required for vendor or site audits.

Qualifications

• 8+ years in pharmaceutical or clinical quality settings.
• Strong knowledge of FDA regulations and ICH-GCP guidelines.
• Experience leading audits and CAPA processes.
• Familiarity with 21 CFR Part 11 preferred.
• Willingness to travel approximately 25% for audits.

Responsibilities

• Lead audits and maintain Annual Audit Plans for internal and CROs.
• Manage eQMS including document control and CAPA management.
• Oversee CSV and Change Control activities across systems.
• Review non-conformances, drive root cause analysis and corrective actions.
• Deliver GCP training to internal and contract personnel.

Skills

Quality Assurance

Audits

GCP

Document Control

CAPA

Training

Education

BS in science or related health discipline

Tools

eQMS

CSV

Change Control

FDA Regulations

Job description

InClin, Inc. is seeking a highly skilled Quality Assurance Manager to join our team in a fully remote capacity. You will oversee QA activities, lead audits, manage the eQMS, CAPAs, and ensure GCP compliance from your home office.

Reporting to the Director of Quality, you will drive continuous improvement, review deviations, conduct risk assessments, and support regulatory inspections. Travel up to ~25% may be required for vendor or site audits.