Director, Quality Systems

At Achieve Life Sciences, we’re preparing to bring an innovative smoking cessation treatment to market and building the quality infrastructure needed to support our next phase of growth. This is an opportunity to help shape the systems, processes, and standards that will support our mission to advance cytisinicline as a treatment option for people battling nicotine dependence.

Reporting to the VP, Global Quality, the Director, Quality Systems will lead the development, implementation, and continuous improvement of Achieve’s integrated Quality Management System (QMS) across GxP activities. Working in close partnership with GMP and GCP Quality leaders, this individual will establish scalable, risk-based quality processes that support compliance, inspection readiness, and operational excellence as the company evolves.

• 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.

• 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.

• Quality-related professional certification.
• Experience developing and…