About the role
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.
What You’ll Do
GCP Quality Assurance
* 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.
PV Compliance Build-Out and Oversight
* 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.
PV Inspection Readiness and Quality Systems
* 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.
What You’ll Bring
* 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.
Preferred Qualifications
* Advanced degree in a relevant discipline. * Quality certification, such as RQAP-GCP.
Who We Are
At Achieve, we are committed to bringing medicines forward that contribute to a healthier world. Achieve is a specialty pharmaceutical company committed to advancing cytisinicline as a widely available treatment option to help people battling nicotine dependence.
If you enjoy working in a dynamic team environment and are passionate about making a difference, we invite you to apply. We strive to attract, develop, and retain highly qualified individuals representing the diverse communities we serve.
Compensation
The anticipated base salary range for this position is $220,000–$235,000 USD annually. This range represents a good-faith estimate of what Achieve reasonably expects to pay for this position at the time of hire. Actual compensation will be determined based on factors including relevant experience, skills, qualifications, and internal equity. This position is also eligible for an annual target bonus and equity compensation as determined by the Company’s compensation committee.
Benefits
Achieve offers a comprehensive benefits package, which currently includes medical, dental, and vision insurance; a 401(k) retirement plan; participation in the Employee Stock Purchase Plan; company-paid life insurance and short- and long-term disability coverage; and paid time off and paid company holidays.
Location & Travel
This is a remote position, and candidates may reside anywhere in the continental United States. This role may require travel of up to 10% for conferences and company meetings. Travel expectations are to be confirmed.
Equal Employment Opportunity
Achieve Life Sciences is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, sexual orientation, and gender identity), national origin, age, disability, genetic information, veteran status, or any other characteristic protected by applicable federal, state, or local law.
If you require a reasonable accommodation to participate in the application or interview process, please contact [email protected].
#LI-AW1