Director, GCP, Pharmacovigilance Quality Assurance

Achieve Life Sciences

. Provide GCP Quality oversight for ongoing Phase 3 and post-marketing clinical studies .

Posted 10/27/2026full-timeRemote • United StatesLead💰 $220,000 - $235,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Expertise in GCP Quality Oversight and Pharmacovigilance (PV) compliance, with a strong focus on risk-based audit planning, regulatory inspection readiness, and effective communication across functions. Proven ability to develop and maintain Quality Agreements and compliance metrics in the biotechnology or pharmaceutical industry.

Highest-signal resume keywords

GCP Quality OversightPharmacovigilance Compliance Program DevelopmentRisk-Based GCP Audit PlanningFDA Post-Marketing Inspection LeadershipKnowledge of FDA Regulations and ICH Guidelines

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

GCP Audit ExecutionCompliance MonitoringQuality Agreement DevelopmentCAPA ManagementSafety Reporting RequirementsInspection Readiness ProgramRegulatory Observation ResponseVendor Audit ManagementClinical Document OversightProtocol Deviation Management

Soft Skills

Excellent CommunicationLeadershipJudgmentCross-Functional CollaborationProblem-Solving

Industry Keywords

BiotechnologyPharmaceutical IndustryClinical StudiesCRO OversightPost-Marketing Safety Reporting21 CFR Parts 312 and 314.80ICH E6ICH E2Trial Master FileCompliance Metrics

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Provide GCP Quality oversight for ongoing Phase 3 and post-marketing clinical studies
Develop and execute risk-based GCP audit plans covering investigator sites, CROs, clinical vendors, the Trial Master File, and computerized systems
Ensure audit findings are communicated appropriately and CAPAs are adequate, effective, and closed on time
Escalate significant compliance issues as appropriate
Provide Quality input on CRO and clinical vendor oversight, protocol deviation management, and key clinical documents
Establish PV-related SOPs, roles and responsibilities, compliance metrics, and governance processes
Develop and maintain the Quality Agreement with the outsourced PV service provider
Establish and maintain monitoring processes for U.S. post-marketing safety reporting requirements, including 15-day Alert Reports, PADERs, signal management, and literature surveillance
Plan and conduct periodic audits of the PV service provider and safety database
Participate in vendor governance meetings and drive corrective actions
Build and maintain the PV inspection readiness program, including inspection playbooks, storyboards, mock inspections, and subject matter expert preparation
Coordinate FDA post-marketing PV inspections, including front-room and back-room operations, document requests, provider collaboration, and responses to Form FDA 483 observations
Maintain GCP inspection readiness and provide inspection support as needed
Report to the SVP, Global Quality

Requirements

What you’ll need

Bachelor’s degree in life sciences or a related field
10+ years of progressive Quality experience in the biotechnology or pharmaceutical industry, including GCP and significant PV Quality Assurance responsibilities
Experience planning and executing risk-based GCP audits of investigator sites, CROs, and clinical vendors
Demonstrated experience building or significantly developing a PV compliance program in a commercial setting, ideally in connection with a product launch
Experience providing Quality oversight of an outsourced PV service provider, including Quality Agreements, KPIs, compliance monitoring, and vendor audits
Direct experience leading or hosting FDA post-marketing PV inspections, including inspection readiness and responses to regulatory observations
Strong knowledge of FDA GCP and post-marketing safety reporting regulations, including 21 CFR Parts 312 and 314.80, and ICH E6 and E2 guidelines
Excellent communication, leadership, and judgment, with the ability to work effectively across functions and with external partners in a lean organization

Benefits

Comp & perks

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
Up to 10% travel for conferences and company meetings