Director, GCP, Pharmacovigilance Quality Assurance

This is a fully remote position, open to applicants in United States.

📋 Description

• Oversee GCP Quality for ongoing Phase 3 and post-marketing clinical trials

• Create and implement risk-based GCP audit strategies for investigator sites, CROs, clinical vendors, the Trial Master File, and computerized systems

• Ensure appropriate communication of audit findings, and that CAPAs are sufficient, effective, and resolved in a timely manner

• Elevate significant compliance concerns as necessary

• Provide Quality insights on CRO and clinical vendor management, protocol deviation handling, and essential clinical documentation

• Develop SOPs related to pharmacovigilance (PV), defining roles and responsibilities, compliance metrics, and governance frameworks

• Create and uphold the Quality Agreement with the external PV service provider

• Establish and manage monitoring systems for U.S. post-marketing safety reporting obligations, including 15-day Alert Reports, PADERs, signal management, and literature monitoring

• Organize and perform regular audits of the PV service provider and the safety database

• Engage in vendor governance meetings and lead corrective actions

• Develop and sustain the PV inspection readiness program, including inspection playbooks, storyboards, mock inspections, and preparation of subject matter experts

• Coordinate FDA post-marketing PV inspections, covering front-room and back-room operations, document requests, provider collaboration, and responses to Form FDA 483 observations

• Maintain GCP inspection readiness and offer inspection support as required

• Report directly to the SVP, Global Quality

⛳️ Requirements

• Bachelor's degree in life sciences or a related discipline

• Over 10 years of advancing Quality experience within the biotechnology or pharmaceutical sector, encompassing GCP and substantial PV Quality Assurance responsibilities

• Proven experience in planning and executing risk-based GCP audits for investigator sites, CROs, and clinical vendors

• Demonstrated capability in building or significantly enhancing a PV compliance program in a commercial context, ideally linked to a product launch

• Experience in providing Quality oversight of an outsourced PV service provider, including Quality Agreements, KPIs, compliance monitoring, and vendor audits

• Direct experience in leading or facilitating FDA post-marketing PV inspections, including inspection readiness and addressing regulatory observations

• In-depth knowledge of FDA GCP and post-marketing safety reporting regulations, including 21 CFR Parts 312 and 314.80, as well as ICH E6 and E2 guidelines

• Exceptional communication, leadership, and judgment skills, with the ability to collaborate effectively across functions and with external partners within a streamlined organization

🏝️ Benefits

• Annual target bonus

• Equity compensation

• Medical insurance

• Dental insurance

• Vision insurance

• 401(k) retirement plan

• Employee Stock Purchase Plan

• Company-paid life insurance

• Company-paid short- and long-term disability coverage

• Paid time off

• Paid company holidays

• Remote work options

• Up to 10% travel for conferences and company meetings