Company Site
Director, Quality Systems
Achieve Life Sciences
USA
Full-time
Director · 8+ years experience
Onsite
USD 220000-235000 / year
Discovered 1 weeks ago
gcp
Key Skills for This Role
gcp
Full Job Posting
What You’ll Do
- Build and lead the Quality Management System: Develop, implement, and maintain an integrated QMS that supports GxP activities across the organization, partnering with GMP and GCP Quality leads to ensure alignment and consistency.
- Establish quality governance and core processes: Own and continuously improve key quality processes, including deviations, CAPA, change control, document control, training, risk management, and computerized system validation (CSV) and computer software assurance (CSA).
- Oversee computerized systems quality: Provide Quality oversight and approval of computerized system validation deliverables and related quality events. Ensure appropriate lifecycle management, risk-based validation approaches, and data integrity practices.
- Drive quality performance and continuous improvement: Establish meaningful quality metrics, prepare quarterly dashboards, lead Quality System Management Reviews, and track actions to drive accountability and sustained improvement.
- Manage post-market quality processes: Oversee complaint intake, logging, investigations, coordination with outsourced vendors, and recall procedures, serving as a key liaison for related activities.
- Maintain inspection and audit readiness: Lead inspection readiness activities, support regulatory inspections and audits, and establish and maintain an effective audit schedule and program.
- Partner across the business: Collaborate with internal stakeholders and external partners to embed quality into business processes while balancing regulatory requirements with practical operational needs.
- Scale quality systems with the organization: Build processes that are appropriately controlled, efficient, and adaptable to the needs of a growing organization preparing for commercialization.
What You’ll Bring
- Bachelor’s degree in a scientific discipline or related field; an advanced degree is a plus.
- 8+ years of experience in GxP Quality within the biotechnology or pharmaceutical industry, including 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, including lifecycle management and risk-based approaches.
- Direct experience supporting regulatory inspections, including Pre-Approval Inspections (PAIs).
- Strong communication and stakeholder management skills, with the ability to collaborate effectively across functions and with external partners.
- Experience working in a fast-growing or evolving organization, with the ability to establish appropriate structure while maintaining flexibility and responsiveness.
- Sound judgment, strong ownership, and a practical, business-minded approach to problem-solving.
Preferred Qualifications
- Quality-related professional certification.
- Experience developing and scaling quality systems to support organizational growth or commercial launch readiness.
- Bachelor’s degree in a scientific discipline or related field; an advanced degree is a plus.
About Achieve Life Sciences
Biotechnology28 employeesFounded 1991
Public specialty pharmaceutical company developing cytisinicline for adults seeking treatment for nicotine dependence and smoking cessation.
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