Senior Manager, Quality Operations

🕒 3 days ago

🇺🇸 United States – Remote

💵 $175k - $190k / year

⏰ Full Time

🟠 Senior

⚙️ Operations

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Achieve Life Sciences

WebsiteLinkedInAll Job Openings

11 - 50 employees

Founded 2015

💊 Pharmaceuticals

🧬 Biotechnology

Pharmaceuticals • Biotechnology

Achieve Life Sciences is a late-stage specialty pharmaceutical company focused on developing cytisinicline as a treatment for nicotine dependence (smoking and vaping cessation). The company is advancing cytisinicline through Phase 2 and Phase 3 ORCA trials and has submitted an NDA; its clinical program targets nicotinic receptors to reduce withdrawal and smoking satisfaction, with the goal of providing a new FDA-approved treatment option for tobacco and nicotine dependence.

📋 Description

• Perform detailed technical reviews of executed batch records, Certificates of Analysis, Certificates of Compliance, laboratory data, stability results, and supporting release documentation • Identify discrepancies, missing information, and potential compliance concerns • Coordinate resolution with CDMOs to support timely batch disposition and release • Conduct initial intake, triage, and review of deviations, investigations, CAPAs, and OOS events from external manufacturing partners • Evaluate investigation documentation and assess product quality and compliance risks • Monitor resolution timelines and support root cause analysis and corrective actions • Participate in product complaint investigations • Help implement commercial complaint-management processes, responsibilities, documentation, and workflows • Apply risk-based judgment to evaluate impacts on product quality and patient safety • Support the transition from clinical-stage quality practices to commercial quality operations • Implement processes and controls for commercial manufacturing, product release, distribution, and post-approval requirements • Support DSCSA serialization and EPCIS data exchange with CDMOs and 3PL providers • Verify traceability data accuracy and completeness from manufacturer to distributor • Serve as 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 and support vendor performance reviews and qualification activities • Participate in Person-in-Plant oversight as needed • Maintain complete, accurate, and inspection-ready documentation • Support Quality Operations metrics and continuous improvement initiatives • Contribute to preparation of the Annual Product Review

🎯 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 • Experience ideally spanning late-stage clinical development and commercial readiness • Hands-on experience reviewing batch records, release documentation, analytical results, and stability data • Experience reviewing deviations, investigations, CAPAs, or other quality events and evaluating their potential impact on product quality, regulatory compliance, and patient safety • Experience working with CDMOs or other external manufacturing partners in an outsourced pharmaceutical or biologics environment • Understanding of quality and distribution requirements for transitioning from clinical supply to commercial product • Knowledge of DSCSA serialization, EPCIS data exchange, and end-to-end product traceability, ideally • Knowledge of applicable GMP regulations and guidance, including FDA, EMA, and ICH requirements • Working knowledge of GCP and GDP is beneficial • Strong attention to detail and documentation discipline • Ability to recognize inconsistencies, assess risk, and follow issues through resolution • Proactive, hands-on approach and ability to work effectively in a lean organization • Clear communication and collaboration skills • Ability to work productively with external partners, raise concerns constructively, and escalate issues when appropriate • Candidates may reside anywhere in the continental United States • Up to 10% travel may be required

🏖️ Benefits

• Annual target bonus • Equity compensation • Medical insurance • Dental insurance • Vision insurance • 401(k) retirement plan • Employee Stock Purchase Plan • Company-paid life insurance • Short- and long-term disability coverage • Paid time off • Paid company holidays • Remote work arrangement • Travel opportunities for conferences and company meetings