Director, Quality Systems

Job not on LinkedIn

🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $220k - $235k / year

⏰ Full Time

🔴 Lead

👔 Director

👻 Ghost score 6%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

Apply Now

Find Similar Remote Jobs

Set Up Email Alert For New Jobs

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume

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