Director, Quality Systems

This is a fully remote position, open to applicants in United States.

📋 Description

• Spearhead the development, implementation, and ongoing enhancement of Achieve’s integrated Quality Management System across GxP operations.

• Collaborate with GMP and GCP Quality leaders to design scalable, risk-based quality processes.

• Take ownership of and enhance processes related to deviations, CAPA, change control, document control, training, risk management, CSV, and CSA.

• Provide Quality oversight and approve computerized system validation deliverables as well as associated quality events.

• Ensure effective lifecycle management, risk-based validation strategies, and adherence to data integrity standards.

• Develop quality metrics and compile quarterly dashboards.

• Lead Quality System Management Reviews and monitor action items.

• Manage complaint intake, documentation, investigations, coordination with external vendors, and recall procedures.

• Direct inspection readiness initiatives and assist during regulatory inspections and audits.

• Create and uphold a robust audit schedule and program.

• Work in partnership with internal stakeholders and external collaborators.

• Design scalable, controlled, efficient, and adaptable quality processes for commercialization.

⛳️ Requirements

• A Bachelor’s degree in a scientific discipline or a related field.

• Over 8 years of experience in GxP Quality within the biotechnology or pharmaceutical sector.

• Proficiency in GMP and GCP environments.

• Proven experience in leading quality professionals and in the development, implementation, or management of a Quality Management System.

• In-depth knowledge of enterprise QMS processes and computerized system validation or computer software assurance.

• Understanding of lifecycle management and risk-based methodologies.

• Direct experience in supporting regulatory inspections, including Pre-Approval Inspections (PAIs).

• Excellent communication skills and stakeholder management capabilities.

• Experience in a fast-paced or evolving organizational environment.

• Professional certification related to quality is preferred.

• Experience in developing and scaling quality systems to facilitate organizational growth or readiness for commercial launch 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 options.

• Travel of up to 10% for conferences and company meetings.