Job Title: Quality Assurance Manager (Clinical & GxP Compliance)
Job Description: Element Staffing is recruiting for a Quality Assurance Manager for a pioneering, clinical-stage biopharmaceutical company located in the Irvine area. This role is a key driver within the Clinical Quality Assurance team, responsible for managing the GCP, GLP, and GVP supplier qualification programs. The successful candidate will play a critical role in inspection readiness, vendor auditing, and ensuring company-wide adherence to global ICH E6 guidelines. This is an exceptional opportunity to join a high-growth organization committed to innovation and patient outcomes.
Duties/Responsibilities/Qualifications:
-
Supplier Qualification: Manage the GCP, GLP, and GVP supplier qualification program, including the maintenance of audit schedules within the QMS.
-
Audit Execution: Perform internal and supplier audits, authoring detailed reports and tracking implementation evidence for corrective actions.
-
QMS Oversight: Review and approve quality records, including deviations, change controls, and CAPAs, ensuring adherence to SOPs and global regulations.
-
Clinical Support: Provide day-to-day quality support to Clinical Development and Operations teams to ensure adherence to ICH guidelines and company policies.
-
Metric Reporting: Create and manage tracking tools to report quality metrics and performance to senior management.
-
Training & Curricula: Manage clinical training curricula and provide GCP/GxP training to internal stakeholders and new hires.
-
Risk Management: Lead and support Risk Assessments and Risk-Based Management (RBM) initiatives across clinical programs.
-
System Review: Conduct periodic reviews of clinical trial systems, including the Trial Master File (TMF) and Clinical Trial Management Systems (CTMS).
-
Inspection Readiness: Assist in cross-functional inspection readiness activities and monitor quality issues through to resolution.
Additional Information:
-
Years of Experience: 8+ years in clinical environments; minimum 5 years within the pharmaceutical industry.
-
Education: Bachelor’s Degree in a Scientific field preferred.
-
Shift/Travel: Hybrid work environment (Irvine-based) with remote flexibility; travel up to 20%.
-
Requirements: In-depth knowledge of FDA/ICH GCP guidelines and international GxP regulations. Experience with root cause analysis and CAPA effectiveness checks is essential.
-
Compensation: $120,000 – $168,000 + Bonus and Equity.
-
Location: Irvine, CA
For immediate consideration, please send your resume to resumes@element-staffing.com.