Senior Manager, Quality Control Operations

Role: Senior Manager of Quality Control (QC) Operations at a late-stage gene therapy biopharma. Primary objectives include leading cross-functional QC projects, optimizing operational workflows, ensuring compliance, and supporting laboratory inspection readiness. Responsibilities encompass project planning and execution, stakeholder coordination with departments like Regulatory, Manufacturing, and Supply Chain, and oversight of external testing partners. The role involves managing QC activities such as inventory, sample logistics, CAPAs, deviations, and laboratory documentation, with an emphasis on operational excellence and continuous improvement. Qualifications: Bachelor's or Master’s degree with 5+ (Master's) or 8+ (Bachelor's) years in GxP-regulated QC within biotech/pharma manufacturing. Experience in QC capacity planning, vendor management, and familiarity with LIMS, LES, and ELN systems. Proficiency in project management tools (e.g., Smartsheet, MS Office) is required; knowledge of Laboratory Information Management Systems is preferred. High-Value specifics include focus on gene therapy (likely viral vectors or other modalities), cGMP compliance, and collaboration across diverse biopharma functions. The position reports to QC leadership, involves strategic project leadership, and requires strong stakeholder engagement. Work setup is not explicitly specified but based on location in Cranbury, NJ, with a focus on operational leadership in a manufacturing environment.