Director, Quality Systems

🕒 3 days ago

🇺🇸 United States – Remote

💵 $220k - $235k / year

⏰ Full Time

🔴 Lead

👔 Director

👻 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

• Lead the development, implementation, and continuous improvement of Achieve’s integrated Quality Management System across GxP activities • Partner with GMP and GCP Quality leaders to establish scalable, risk-based quality processes • Own and improve deviations, CAPA, change control, document control, training, risk management, CSV, and CSA processes • Provide Quality oversight and approval of computerized system validation deliverables and related quality events • Ensure lifecycle management, risk-based validation approaches, and data integrity practices • Establish quality metrics and prepare quarterly dashboards • Lead Quality System Management Reviews and track actions • Oversee complaint intake, logging, investigations, outsourced vendor coordination, and recall procedures • Lead inspection readiness activities and support regulatory inspections and audits • Establish and maintain an effective audit schedule and program • Collaborate with internal stakeholders and external partners • Build scalable, controlled, efficient, and adaptable quality processes for commercialization

🎯 Requirements

• Bachelor’s degree in a scientific discipline or related field • 8+ years of experience in GxP Quality within the biotechnology or pharmaceutical industry • Experience across GMP and GCP environments • Demonstrated experience leading quality professionals and building, implementing, or managing a Quality Management System • Strong knowledge of enterprise QMS processes and computerized system validation or computer software assurance • Knowledge of lifecycle management and risk-based approaches • Direct experience supporting regulatory inspections, including Pre-Approval Inspections (PAIs) • Strong communication and stakeholder management skills • Experience working in a fast-growing or evolving organization • Quality-related professional certification is preferred • Experience developing and scaling quality systems to support organizational growth or commercial launch readiness is preferred

🏖️ Benefits

• Annual target bonus • Equity compensation • Medical insurance • Dental insurance • Vision insurance • 401(k) retirement plan • Employee Stock Purchase Plan • Company-paid life insurance • Short- and long-term disability coverage • Paid time off • Paid company holidays • Remote work • Travel of up to 10% for conferences and company meetings

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