Director, Quality Systems

Achieve Life Sciences

13d•$220,000 - $235,000•Remote

About The Position

The Director, Quality Systems will lead the development, implementation, and continuous improvement of Achieve Life Sciences’ integrated Quality Management System (QMS) across GxP activities. Reporting to the VP, Global Quality, the role partners closely with GMP and GCP Quality leaders to establish scalable, risk-based quality processes that support compliance, inspection readiness, and operational excellence as the company prepares for commercialization. The position oversees core enterprise quality processes and computerized systems quality, drives quality performance and management reviews, manages post-market quality activities, and leads inspection readiness and audit programs. It also works with internal stakeholders and external partners to embed quality in business processes and to scale systems that are controlled, efficient, and adaptable to a growing organization. This is a remote position open to candidates residing anywhere in the continental United States. Travel of up to 10% may be required for conferences and company meetings. The anticipated annual base salary is $220,000–$235,000, with eligibility for an annual target bonus and equity compensation. Benefits include medical, dental, and vision insurance; a 401(k) plan; Employee Stock Purchase Plan participation; company-paid life insurance and short- and long-term disability coverage; paid time off; and paid company holidays.

Requirements

Bachelor’s degree in a scientific discipline or related field.
At least 8 years of GxP Quality experience in 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 and establishing appropriate structure while maintaining flexibility and responsiveness.
Sound judgment, strong ownership, and a practical, business-minded approach to problem-solving.

Nice To Haves

An advanced degree.
Quality-related professional certification.
Experience developing and scaling quality systems to support organizational growth or commercial launch readiness.

Responsibilities

Develop, implement, and maintain an integrated QMS supporting GxP activities across the organization, partnering with GMP and GCP Quality leads to ensure alignment and consistency.
Own and continuously improve deviations, CAPA, change control, document control, training, risk management, computerized system validation (CSV), and computer software assurance (CSA) processes.
Provide Quality oversight and approval of computerized system validation deliverables and related quality events; ensure lifecycle management, risk-based validation, and data integrity practices.
Establish quality metrics, prepare quarterly dashboards, lead Quality System Management Reviews, and track actions to promote accountability and sustained improvement.
Oversee complaint intake, logging, investigations, coordination with outsourced vendors, and recall procedures; serve as a key liaison for related activities.
Lead inspection readiness, support regulatory inspections and audits, and establish and maintain an effective audit schedule and program.
Collaborate with internal stakeholders and external partners to embed quality in business processes while balancing regulatory requirements with operational needs.
Develop quality systems that are appropriately controlled, efficient, and adaptable to the needs of a growing organization preparing for commercialization.