Senior Manager, Clinical Quality Assurance

Senior Manager, Clinical Quality Assurance

Sci Pro is partnered with a commercialised clinical-stage pharmaceutical company that is searching for a Senior Manager, Clinical Quality Assurance to join their team full-time. This is a fantastic opportunity to work at an innovative and growing company with strong financial stability. Due to its commercial drug portfolio (soon to be expanded), the company’s revenue funds ongoing development.

This is a hybrid role with 3 days onsite in the Bay Area.

• (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.

• BA/BS degree in a relevant field (or equivalent experience) with 8+ years of clinical research experience and a solid understanding of Quality Systems supporting GCP activities.
• Strong experience developing GCP processes aligned with industry best practices, including training and implementation.

• Mid-Senior level

• Full-time

• Quality Assurance and Science

• Medical insurance
• Vision insurance
• 401(k)