Senior Consultant, Quality and Compliance

POSITION OVERVIEW

The Senior Consultant, GCP is an experienced clinical quality professional who independently leads GCP quality and compliance engagements for Syner-G's sponsor clients — primarily virtual and emerging biotechs running Phase 1 through Phase 3 clinical programs. This role functions as the embedded clinical quality voice for client programs: overseeing CROs and clinical vendors, auditing investigator sites and vendor systems, advising on sponsor oversight strategy, and ensuring clinical programs are inspection-ready against FDA, EMA, and ICH GCP expectations.

Consistent with the Syner-G Senior Consultant level, the role requires the confidence and judgment to lead client decision-making, defend recommendations against scrutiny, and operate independently across the full clinical development lifecycle. This is an individual-contributor role with significant client-facing accountability; it is not a people-management role.

JOB FUNCTIONS

(This list is not exhaustive and may be supplemented and changed as necessary.)

• Leads GCP quality and compliance engagements for sponsor clients
• Oversees CROs and clinical vendors
• Audits investigator sites and vendor systems
• Advises on sponsor oversight strategy
• Ensures clinical programs are inspection-ready against FDA, EMA, and ICH GCP expectations