Senior Manager, Quality Operations

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Senior Manager, Quality Operations based in the United States. Join a growing pharmaceutical organization preparing to transition an innovative smoking cessation treatment from clinical development to commercial launch. As Senior Manager, Quality Operations, you will play a hands-on role in ensuring product quality, regulatory compliance, and patient safety throughout manufacturing and distribution. You will oversee critical quality activities, including batch documentation review, release support, quality investigations, and risk management. Working closely with external manufacturing and distribution partners, you will help establish the processes and controls needed for commercial operations. You will also contribute to serialization, end-to-end product traceability, and inspection readiness. This remote opportunity is ideal for an experienced quality professional who thrives in a dynamic environment and wants to make a meaningful impact on patients’ lives. Accountabilities: In this role, you will support day-to-day Quality Operations while helping establish the systems and partnerships required for commercial pharmaceutical supply. Your main responsibilities will include: - Batch Review and Release Support: Review executed batch records, Certificates of Analysis (CoAs), Certificates of Compliance (CoCs), laboratory data, stability results, and supporting release documentation. Identify discrepancies and compliance concerns, coordinate resolution with contract development and manufacturing organizations (CDMOs), and support timely batch disposition and release. - Quality Events and Investigations: Review and triage deviations, investigations, corrective and preventive actions (CAPAs), and out-of-specification (OOS) events from external manufacturing partners.

Assess potential quality and compliance risks, monitor resolution timelines, and support appropriate root cause analysis and corrective actions. - Product Complaints and Risk Management: Participate in complaint investigations and help implement the processes, responsibilities, and documentation required for commercial complaint management. Evaluate potential impacts on product quality and patient safety, identify emerging concerns, and escalate issues appropriately. - Commercial Quality Readiness: Collaborate with the Senior Director, Quality Operations and Supplier Quality Management, cross-functional stakeholders, and external vendors to implement the processes and controls needed for commercial launch, manufacturing, product release, distribution, and post-approval requirements. - Serialization and Product Traceability: Work 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. Verify the accuracy and completeness of traceability data throughout the pharmaceutical supply chain. - External Partner Management: Serve as a day-to-day Quality Operations contact for CDMOs and the 3PL, coordinating documentation, quality events, release requirements, and distribution issues. Monitor quality trends, support vendor performance reviews and qualification activities, and participate in Person-in-Plant oversight as needed. - Inspection Readiness and Reporting: Maintain accurate, complete, and inspection-ready documentation. Support Quality Operations metrics, continuous improvement initiatives, and preparation of the Annual Product Review. Requirements: The ideal candidate combines strong pharmaceutical GMP expertise with practical experience managing quality activities in an outsourced manufacturing environment. You should be detail-oriented, proactive, and comfortable making risk-based decisions while working in a lean organization.