Senior Manager, Quality Operations

Achieve Life Sciences

4d•$175,000 - $190,000•Remote

About The Position

Achieve Life Sciences is preparing for the potential commercial launch of cytisinicline, an innovative smoking cessation treatment, and is building the Quality Operations processes and external partnerships needed to support compliant product supply and maintain product quality from manufacturing through distribution. The Senior Manager, Quality Operations will play a hands-on role in batch documentation review, quality event management, and product release support as the company transitions from clinical development to commercialization. Working with external manufacturing and distribution partners, the Senior Manager will support day-to-day quality activities and help implement processes for commercial supply, including product complaint investigations, serialization, and end-to-end product traceability. The role requires attention to detail, risk-based judgment, and the ability to identify and escalate quality concerns that could affect product quality, compliance, or patient safety. This is a remote position for candidates residing in the continental United States, with travel of up to 10% for conferences and company meetings.

Requirements

Bachelor’s degree in life sciences or a related field, or equivalent relevant industry experience.
At least 7 years of GMP Quality experience in the biotechnology or pharmaceutical industry.
Hands-on experience reviewing batch records, release documentation, analytical results, and stability data, including identifying discrepancies and ensuring documentation accuracy.
Experience reviewing deviations, investigations, CAPAs, or other quality events and assessing potential impacts on product quality, regulatory compliance, and patient safety.
Experience working with CDMOs or other external manufacturing partners in an outsourced pharmaceutical or biologics environment.
Knowledge of applicable GMP regulations and guidance, including FDA, EMA, and ICH requirements.
Strong attention to detail and documentation discipline, with the ability to recognize inconsistencies, assess risk, and follow issues through resolution.
Proactive, hands-on approach and ability to work effectively in a lean organization while balancing routine execution with evolving commercial launch priorities.
Clear communication and collaboration skills, including the ability to work productively with external partners, raise concerns constructively, and escalate issues when appropriate.

Nice To Haves

GMP Quality experience spanning late-stage clinical development and commercial readiness.
Understanding of quality and distribution requirements involved in transitioning from clinical supply to commercial product, ideally including DSCSA serialization, EPCIS data exchange, and end-to-end product traceability.
Working knowledge of GCP and GDP.

Responsibilities

Perform technical reviews of executed batch records, Certificates of Analysis (CoAs), Certificates of Compliance (CoCs), laboratory data, stability results, and supporting release documentation; identify discrepancies and coordinate resolution with CDMOs.
Conduct initial intake, triage, and review of deviations, investigations, CAPAs, and out-of-specification events initiated by external manufacturing partners; assess risks, monitor timelines, and support root cause analysis and corrective actions.
Participate in product complaint investigations and help implement commercial complaint management processes, responsibilities, documentation, and workflows.
Help implement processes and controls required for commercial launch, including those supporting commercial manufacturing, product release, distribution, and post-approval requirements.
Work with CDMOs and third-party logistics providers to support DSCSA serialization requirements and EPCIS data exchange, and verify the accuracy and completeness of traceability data.
Serve as a day-to-day Quality Operations contact for CDMOs and the 3PL; follow up on documentation, quality events, release requirements, and distribution issues.
Monitor operational quality trends, support vendor performance reviews and qualification activities, and participate in Person-in-Plant oversight as needed.
Maintain complete, accurate, inspection-ready documentation; support Quality Operations metrics and continuous improvement initiatives; and contribute to preparation of the Annual Product Review.