Director, GCP and Pharmacovigilance; PV) Quality Assurance

As Achieve Life Sciences prepares for the potential approval and commercial launch of cytisinicline, we’re building the quality and compliance capabilities needed to support our next phase of growth. This is an opportunity to play a critical role in ensuring clinical quality and establishing a robust pharmacovigilance (PV) compliance program to support commercialization.

Reporting to the SVP, Global Quality, the Director, GCP and Pharmacovigilance Quality Assurance will lead GCP Quality oversight of ongoing clinical studies and build Achieve’s U.S. PV compliance program in preparation for launch. This individual will partner closely with Achieve’s outsourced PV service provider and cross‑functional stakeholders to establish effective oversight, maintain regulatory compliance, and lead PV inspection readiness and inspections.

• Oversee GCP quality:
  Provide GCP Quality oversight for ongoing Phase 3 and post‑marketing clinical studies.
• Lead risk‑based audit programs:
  Develop and execute GCP audit plans covering investigator sites, CROs, clinical vendors, the Trial Master File (TMF), and computerized systems, utilizing qualified contract auditors as needed.
• Drive audit findings and CAPAs:
  Ensure audit findings are communicated appropriately and that corrective and preventive actions (CAPAs) are adequate, effective, and closed on time. Escalate significant compliance issues as appropriate.
• Partner with Clinical Operations:
  Provide Quality input on CRO and clinical vendor oversight, protocol deviation management, and key clinical documents.

• Build the commercial PV compliance program:
  Partner with the outsourced PV service provider, Drug Safety, Regulatory Affairs, and Quality Systems to establish PV‑related SOPs, roles and responsibilities, compliance metrics, and governance processes.
• Establish vendor quality governance:
  Develop and maintain the Quality Agreement with the PV service provider, defining KPIs, compliance thresholds, escalation pathways, and clear accountabilities while recognizing Achieve’s responsibilities as the NDA holder.
• Monitor post‑marketing safety compliance:
  Establish and maintain monitoring processes for U.S. post‑marketing safety reporting requirements, including timely submission of 15‑day Alert Reports and Periodic Adverse Drug Experience Reports (PADERs), signal management, and literature surveillance.
• Audit and oversee the PV provider:
  Plan and conduct periodic audits of the PV service provider and safety database, participate in vendor governance meetings, and drive corrective actions when compliance gaps are identified.

• Lead PV inspection readiness:
  Build and maintain the PV inspection readiness program in partnership with the Quality Management team, including inspection playbooks, storyboards, mock inspections, and preparation of internal and provider subject matter experts.
• Lead FDA post‑marketing PV inspections:
  Coordinate inspection activities, including front‑room and back‑room operations, document requests, collaboration with the PV service provider, and responses to regulatory observations, including Form FDA 483 observations.
• Maintain GCP inspection readiness:
  Ensure ongoing readiness for inspections related to clinical study activities and provide inspection support as needed.

• 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…