Note: The job is a remote job and is open to candidates in USA. Achieve Life Sciences is preparing for the potential commercial launch of cytisinicline and establishing the quality operations processes and external partnerships needed to support compliant product supply. The Senior Manager, Quality Operations supports batch documentation review, quality event management, product release, product complaints, serialization, and product traceability as the company transitions from clinical development to commercialization.
Responsibilities
- 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 escalate 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 into 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 operational quality trends, support vendor performance reviews and qualification activities, and participate in Person-in-Plant oversight as needed
- Maintain Inspection Readiness & Quality Reporting: Maintain complete, accurate, and inspection-ready documentation for activities within the role’s scope. Support Quality Operations metrics and continuous improvement initiatives and contribute to preparation of the Annual Product Review
Skills
- 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, with a strong track record of identifying discrepancies and ensuring documentation accuracy
- 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 the additional quality and distribution requirements involved in transitioning from clinical supply to commercial product
- 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
- A proactive, hands-on approach and the ability to work effectively in a lean organization, 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
- Ideally spanning late-stage clinical development and commercial readiness
- Ideally including DSCSA serialization, EPCIS data exchange, and end-to-end product traceability
- Working knowledge of GCP and GDP is beneficial
Benefits
- Medical, dental, and vision insurance
- A 401(k) retirement plan
- Participation in the Employee Stock Purchase Plan
- Company-paid life insurance
- Short- and long-term disability coverage
- Paid time off
- Paid company holidays
- Annual target bonus
- Equity compensation
- Remote position; candidates may reside anywhere in the continental United States
Company Overview