Senior Manager, Quality Operations

At Achieve Life Sciences, we’re preparing to bring an innovative smoking cessation treatment to market and building the capabilities needed to support our next phase of growth. As we prepare for the potential commercial launch of cytisinicline, we’re establishing the Quality Operations processes and external partnerships needed to support compliant product supply and maintain product quality from manufacturing through distribution.

Reporting to the Senior Director, Quality Operations and Supplier Quality Management, the Senior Manager, Quality Operations will play a hands‑on role in batch documentation review, quality event management, and product release support as Achieve transitions from clinical development to commercialization. Working closely with David and external manufacturing and distribution partners, this individual will support day‑to‑day quality activities while helping implement the additional processes required for commercial supply, including product complaint investigations, serialization, and end‑to‑end product traceability.

Success in this role requires exceptional attention to detail, sound risk‑based judgment, and the ability to identify and expand quality concerns that could affect product quality, compliance, or patient safety.

• Execute Batch Review & Release Support:
  Perform detailed technical reviews of executed batch records, Certificates of Analysis (CoAs), Certificates of Compliance (CoCs), laboratory data, stability results, and supporting release documentation. Identify discrepancies, missing information, and potential compliance concerns, and coordinate resolution with contract development and manufacturing organizations (CDMOs) to support timely batch disposition and release.
• Review Quality Events & Investigations:
  Conduct initial intake, triage, and review of deviations, investigations, corrective and preventive actions (CAPAs), and out‑of‑specification (OOS) events initiated by external manufacturing partners. Evaluate investigation documentation, assess potential product quality and compliance risks, monitor resolution timelines, and partner with CDMOs to support appropriate root cause analysis and corrective actions.
• Support Product Complaints & Quality
  
  Risk Management:
  
  Participate in product complaint investigations and help implement the processes, responsibilities, documentation, and workflows needed to manage complaints in a commercial environment. Apply risk‑based judgment to evaluate potential impacts to product quality and patient safety, identify emerging concerns, and escalation issues appropriately.
• Support the Transition to Commercial Quality Operations:
  Partner with the Senior Director, Quality Systems, cross‑functional stakeholders, and external vendors to implement the additional processes and controls required for commercial launch. Help translate clinical‑stage quality practices to processes that support commercial manufacturing, product release, ongoing distribution, and post‑approval requirements.
• Support Serialization & End‑to‑End Product Traceability:
  Partner with CDMOs and third‑party logistics (3PL) providers to support Drug Supply Chain Security Act (DSCSA) serialization requirements and Electronic Product Code Information Services (EPCIS) data exchange. Help verify the accuracy and completeness of traceability data as product moves from manufacturer to distributor, supporting compliant distribution and the integrity of the pharmaceutical supply chain.
• Manage External Quality Partnerships:
  Serve as a day‑to‑day Quality Operations contact for CDMOs and the 3PL, following up on documentation, quality events, release requirements, and distribution issues. Monitor…