Director, GCP, Pharmacovigilance Quality Assurance

🕒 3 days ago

🇺🇸 United States – Remote

💵 $220k - $235k / year

⏰ Full Time

🔴 Lead

🔧 QA Engineer (Quality Assurance)

👻 Ghost score 9%

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Achieve Life Sciences

WebsiteLinkedInAll Job Openings

11 - 50 employees

Founded 2015

💊 Pharmaceuticals

🧬 Biotechnology

Pharmaceuticals • Biotechnology

Achieve Life Sciences is a late-stage specialty pharmaceutical company focused on developing cytisinicline as a treatment for nicotine dependence (smoking and vaping cessation). The company is advancing cytisinicline through Phase 2 and Phase 3 ORCA trials and has submitted an NDA; its clinical program targets nicotinic receptors to reduce withdrawal and smoking satisfaction, with the goal of providing a new FDA-approved treatment option for tobacco and nicotine dependence.

📋 Description

• 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

• 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

• 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

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