US-Based QA Consultant for Early Access Programs

ARAVAS INC; Pennsylvania; On-site; USD 90,000 - 180,000; Full time

Job summary

Savara is seeking a Consultant of Clinical Quality Assurance and Early Access Programs to support quality oversight and management of GCP activities related to the Early Access Program (EAP), during which investigational product is provided while pivotal data is under Health Authority review.

The consultant will oversee vendors, review project plans, generate quality events, and drive risk mitigation. Remote work is allowed within the U.S. for 120–170 hours/month over 12 months.

Qualifications

• GCP quality oversight for Early Access Programs
• QA leadership and SME guidance on EAP activities
• Experience with CAPA, SOPs and regulatory submissions
• Vendor oversight and audit coordination

Responsibilities

• Provide Clinical Quality Assurance (GCP) leadership and SME to the Early Access Program (EAP) Team
• Perform a gap assessment on vendors and identify a remediation plan as needed
• Assess the medical review process for proper documentation
• Provide strategy and execution in the anticipated transition of patients to commercial product
• Generate and coordinate documentation of quality events, including CAPA plans
• Author, revise and maintain QA SOPs
• Provide QA SME to reviews of clinical protocols, amendments, informed consent forms, and regulatory submission documents
• Plan, conduct, and/or assist in internal and external service provider audits

Job description

Savara is seeking a Consultant of Clinical Quality Assurance and Early Access Programs to support quality oversight and management of GCP activities related to the Early Access Program (EAP), during which investigational product is provided while pivotal data is under Health Authority review.

The consultant will oversee vendors, review project plans, generate quality events, and drive risk mitigation. Remote work is allowed within the U.S. for 120–170 hours/month over 12 months.