Director, Quality Systems

Achieve Life Sciences

. Lead the development, implementation, and continuous improvement of Achieve’s integrated Quality Management System across GxP activities .

Posted 10/27/2026full-timeRemote • United StatesLead💰 $220,000 - $235,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in developing and managing Quality Management Systems (QMS) within GxP environments, with a strong focus on risk-based validation, compliance, and continuous improvement. Proven ability to lead quality oversight for regulatory inspections and audits while collaborating effectively with stakeholders.

Highest-signal resume keywords

GxP Quality ExperienceQuality Management System DevelopmentComputerized System ValidationRegulatory Inspection SupportStakeholder Management

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Quality Management SystemDeviations ManagementCAPA ProcessesChange ControlDocument ControlRisk ManagementCSVCSAQuality MetricsAudit Program Management

Soft Skills

Strong CommunicationStakeholder ManagementLeadership

Certifications & Qualifications

Quality-Related Professional Certification

Industry Keywords

GMPGCPBiotechnologyPharmaceuticalLifecycle ManagementRisk-Based ApproachesPre-Approval InspectionsQuality OversightComplaint ManagementInspection Readiness

About the role

Key responsibilities & impact

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

What you’ll need

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

Comp & perks

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