Apply on Employer Site

SciPro · 10 hours ago

Senior Manager, Clinical Quality Assurance

San Francisco Bay Area

Full-time

Hybrid

Senior Level, Lead/Staff

8+ years exp

SciPro is partnered with a commercialised clinical-stage pharmaceutical company that's searching for a Senior Manager, Clinical Quality Assurance to join their team full-time. This role involves leading and managing GCP-related audits, providing compliance guidance, and driving continuous improvement of the Clinical Quality Management System.

EmploymentOutsourcingRecruitingStaffing Agency

Hiring Manager

Erica (Sanchez) Steckler

Responsibilities

Lead and manage all GCP-related audits (site, vendor, internal, TMF, CSRs) and oversee study-specific Clinical Study Audit Plans using a risk-based approach

Serve as the QA representative to clinical study teams, providing compliance guidance and reviewing/approving clinical study documents, SOPs, and guidance materials

Drive continuous improvement of the Clinical Quality Management System (CQMS), including creation and revision of GCP-compliant SOPs and processes

Support and manage GCP inspection readiness and participate in GCP, GMP, GLP, PV, sponsor, site, and CRO regulatory inspections

Lead investigations of clinical non-compliance events, oversee CAPA implementation, and perform QA quality metric analyses (protocol deviations, safety data, trends, etc.)

Review and approve investigational product temperature excursions, maintain GCP regulatory surveillance, and provide training, mentoring, and cross-development for QA team members