QA Consultant – Early Access & GCP Compliance

Savara Inc.; Pennsylvania; On-site; USD 103,000 - 179,000; Part time

Job summary

Savara Inc. is seeking a Consultant for Clinical Quality Assurance and Early Access Programs to oversee GCP activities related to the Early Access Program (EAP). You will act as QA SME to the EAP team, conduct vendor reviews, and help manage quality events and regulatory documentation.

The role includes CAPA strategy, SOP maintenance, and audits of providers, with potential transition support to commercial product depending on Health Authority decisions. Remote within the U.S. is acceptable.

Qualifications

• Experience providing Clinical Quality Assurance oversight for GCP activities.
• Ability to lead QA SME support for Early Access Program teams.
• Experience reviewing regulatory submission documents and protocols.

Responsibilities

• Provide GCP QA leadership and SME support to the EAP Team.
• Perform vendor assessments and remediation planning.
• Review medical review processes and related documentation.
• Coordinate quality event management, CAPA plans, and corrective actions.
• Draft, revise and maintain QA SOPs as needed.
• Audit internal and external service providers for adequacy of CAPA actions.

Skills

GCP

Quality Assurance

Vendor Oversight

CAPA Plans

SOP Development

Job description

Savara Inc. is seeking a Consultant for Clinical Quality Assurance and Early Access Programs to oversee GCP activities related to the Early Access Program (EAP). You will act as QA SME to the EAP team, conduct vendor reviews, and help manage quality events and regulatory documentation.

The role includes CAPA strategy, SOP maintenance, and audits of providers, with potential transition support to commercial product depending on Health Authority decisions. Remote within the U.S. is acceptable.