Director, Quality Systems - Remote & GxP Compliance Leader

Achieve Life Sciences, Inc.; United States; Remote; USD 220.000 - 235.000; Vollzeit

Benefits dieser Stelle

Medical, dental, vision

401(k) plan

Stock purchase plan

Life insurance

Disability insurance

Paid time off

Company holidays

Zusammenfassung

Achieve Life Sciences, Inc. is seeking a Director, Quality Systems to lead the development, implementation, and continuous improvement of an integrated QMS across GxP activities.

You will partner with GMP and GCP Quality leaders to enable compliance, inspection readiness, and operational excellence in a fast-growing biotechnology environment. You will establish governance, oversee validated computerized systems, CAPA, deviations, change control, and risk management while aligning quality with

Qualifikationen

• 8+ years of experience in GxP Quality within biotech or pharma.
• Experience leading QMS development and implementation.
• Experience supporting regulatory inspections.

Aufgaben

• Develop, implement, and maintain an integrated QMS across GxP activities.
• Establish governance for deviations, CAPA, change control, and document control.
• Oversee computerized system validation and data integrity practices.
• Drive quality metrics, dashboards, and management reviews.
• Lead post-market quality processes and inspection readiness.

Kenntnisse

GxP Quality

Quality Systems

Regulatory inspections

Stakeholder management

Cross-functional collaboration

Risk-based thinking

Ausbildung

Bachelor’s degree in science

Advanced degree preferred

Tools

QMS software

CSV/CSA lifecycle

Jobbeschreibung

Achieve Life Sciences, Inc. is seeking a Director, Quality Systems to lead the development, implementation, and continuous improvement of an integrated QMS across GxP activities.

You will partner with GMP and GCP Quality leaders to enable compliance, inspection readiness, and operational excellence in a fast-growing biotechnology environment. You will establish governance, oversee validated computerized systems, CAPA, deviations, change control, and risk management while aligning quality with