Director, GCP & PV QA (Remote)

Achieve Life Sciences, Inc.; United States; Remote; USD 220,000 - 235,000; Full time

Benefits offered by this job

Medical, dental, and vision insurance

401(k) retirement plan

Employee Stock Purchase Plan

Company-paid life insurance

Short- and long-term disability

Paid time off and holidays

Annual bonus eligibility

Equity compensation

Job summary

Achieve Life Sciences is seeking a Director of GCP and Pharmacovigilance Quality Assurance to establish and lead the GCP QA program and build a robust PV compliance framework in preparation for launch. This remote role reports to the SVP, Global Quality and partners with outsourced PV services, with heavy emphasis on inspection readiness and regulatory compliance.

The role requires 10+ years in biotech/pharma quality with GCP and PV QA, and experience managing vendor audits, CAPAs, and FDA

Qualifications

• Bachelor’s degree in life sciences or related field.
• 10+ years QA with GCP and PV QA responsibilities.
• Experience building PV compliance program for product launch.
• Experience overseeing outsourced PV service provider.
• FDA post‑marketing PV inspection experience.

Responsibilities

• Provide GCP Quality oversight for ongoing Phase 3 and post‑marketing studies.
• Develop and execute GCP audit plans covering sites, CROs, vendors, TMF, and computerized systems.
• Ensure CAPAs are effective and closed on time; escalate significant issues as needed.
• Provide QA input on CRO/vendor oversight, deviation management, and key documents.
• Build PV compliance program with outsourced PV provider and governance processes.
• Establish Quality Agreement with PV provider including KPIs and escalation.
• Monitor post‑marketing safety reporting requirements including 15‑day reports and PADERs.
• Audit PV provider and safety database; participate in governance meetings and drive corrective actions.

Skills

Quality Assurance

GCP

PV Quality

Audit planning

Cross-functional collaboration

Regulatory knowledge

FDA PV inspections

Communication

Leadership

Education

Bachelor’s degree in life sciences

Advanced degree

Job description

Achieve Life Sciences is seeking a Director of GCP and Pharmacovigilance Quality Assurance to establish and lead the GCP QA program and build a robust PV compliance framework in preparation for launch. This remote role reports to the SVP, Global Quality and partners with outsourced PV services, with heavy emphasis on inspection readiness and regulatory compliance.

The role requires 10+ years in biotech/pharma quality with GCP and PV QA, and experience managing vendor audits, CAPAs, and FDA