Director, GCP and Pharmacovigilance (PV) Quality Assurance

Achieve Life Sciences

9d•$220,000 - $235,000•Remote

About The Position

Achieve Life Sciences is preparing for the potential approval and commercial launch of cytisinicline and is building the quality and compliance capabilities needed for its next phase of growth. The Director, GCP and Pharmacovigilance Quality Assurance will lead GCP Quality oversight of ongoing clinical studies and develop Achieve’s U.S. pharmacovigilance (PV) compliance program in preparation for launch. Reporting to the SVP, Global Quality, the role partners with an outsourced PV service provider and cross-functional stakeholders to establish oversight, maintain regulatory compliance, and lead PV inspection readiness and inspections. The position oversees GCP quality for ongoing Phase 3 and post-marketing studies; develops and executes risk-based audits; and ensures findings and corrective and preventive actions are properly addressed. It also builds and oversees the commercial PV compliance program, including procedures, vendor governance, post-marketing safety monitoring, and audits of the PV provider and safety database. The Director leads PV inspection readiness and FDA post-marketing PV inspections, coordinating inspection operations, document requests, provider collaboration, and responses to regulatory observations. The role also maintains readiness for inspections relating to clinical study activities. This is a remote position for candidates residing in the continental United States, with travel of up to 10% possible. The position offers a base salary range of $220,000–$235,000 annually, plus eligibility for an annual target bonus and equity compensation.

Requirements

Bachelor’s degree in life sciences or a related field.
10 or more 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.
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.

Nice To Haves

Advanced degree in a relevant discipline.
Quality certification, such as RQAP-GCP.
Experience developing a PV compliance program in connection with a product launch.

Responsibilities

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, using qualified contract auditors as needed.
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 the commercial PV compliance program with the outsourced PV service provider and internal stakeholders, including PV-related SOPs, roles and responsibilities, compliance metrics, and governance processes.
Develop and maintain the Quality Agreement with the PV service provider, defining KPIs, compliance thresholds, escalation pathways, and accountabilities while recognizing Achieve’s responsibilities as the NDA holder.
Establish and maintain monitoring processes for U.S. post-marketing safety reporting, including timely submission of 15-day Alert Reports and 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 when compliance gaps are identified.
Build and maintain the PV inspection readiness program 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, coordinating 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 and provide inspection support as needed.
Partner effectively with cross-functional stakeholders and external partners.