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.
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.
Who We Are
At Achieve, we are committed to bringing medicines forward that contribute to a healthier world. Achieve is a specialty pharmaceutical company committed to advancing cytisinicline as a widely available treatment option to help people battling nicotine dependence.
If you enjoy working in a dynamic team environment and are passionate about making a difference, we invite you to apply. We strive to attract, develop, and retain highly qualified individuals representing the diverse communities we serve.
Compensation
The anticipated base salary range for this position is $220,000–$235,000 USD annually. This range represents a good-faith estimate of what Achieve reasonably expects to pay for this position at the time of hire. Actual compensation will be determined based on factors including relevant experience, skills, qualifications, and internal equity. This position is also eligible for an annual target bonus and equity compensation as determined by the Company’s compensation committee.
Benefits
Achieve offers a comprehensive benefits package, which currently includes medical, dental, and vision insurance; a 401(k) retirement plan; participation in the Employee Stock Purchase Plan; company-paid life insurance and short- and long-term disability coverage; and paid time off and paid company holidays.
Location & Travel
This is a remote position, and candidates may reside anywhere in the continental United States. This role may require travel of up to 10% for conferences and company meetings.
Equal Employment Opportunity
Achieve Life Sciences is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, sexual orientation, and gender identity), national origin, age, disability, genetic information, veteran status, or any other characteristic protected by applicable federal, state, or local law.
If you require a reasonable accommodation to participate in the application or interview process, please contact [email protected].
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