Hiring: Senior Manager, Microbiology (CVRM) Company: Genentech Location: Holly Springs, NC Job Posted Time: 2026-09-10 11:45:12 Target Skills & Keywords : Project Management, Six Sigma About the job Experience: •8 years of experience in pharmaceutical or biopharmaceutical manufacturing. This includes at least 3 years of direct experience in QC operations at a finished drug product commercial manufacturing site. •At least 3 years of direct experience in QC operations at a finished drug product commercial manufacturing site. Required Skills: •The Holly Springs Quality Control Team is seeking an experienced and dynamic leader to establish and head our QC Microbiology team. •Champion a proactive quality culture built on psychological safety and transparent communication—empowering your team to speak up, simplify processes, and take personal accountability for owning quality. •Drive a proactive safety culture by fostering Behavior-Based Safety (BBS) principles and ensuring strict compliance with site safety processes and regulatory standards. •Foster a high-performing, engaged lab culture by practicing Lean Leadership, providing active coaching, and embedding continuous improvement into daily operations. •Ensure appropriate staffing, resource allocation, and workload balancing to support business priorities and changing operational demands •Partner with the global network to harmonize QC standards and ensure seamless execution and compliance across site operations. •Establish key operational performance measures (KPIs) with a focus on Compliance, Right-First-Time (RFT) execution and continuous improvement to meet business objectives. •Author, review, and approve critical technical, scientific, and compliance documents (e.g., test methods, validation protocols, SOPs). Qualifications: •You hold a B.S. or M.S. degree (Science related discipline) with a minimum of 8 years of experience in pharmaceutical or biopharmaceutical manufacturing. This includes at least 3 years of direct experience in QC operations at a finished drug product commercial manufacturing site. •You have extensive technical knowledge of Microbiology methods, laboratory instrumentation, and analytical method validation, qualification, and transfer within the pharmaceutical or biopharmaceutical industry. •You have extensive experience in contamination control strategies, environmental and utility system monitoring. •You have in-depth working knowledge of cGMP operations, ICH guidelines, and global Health Authority regulatory requirements. •You have proven technical leadership capabilities and demonstrated project management skills, with a track record of effectively managing workload distribution, timelines, and competing priorities. •You have exceptional communication skills with the demonstrated ability to inspire, motivate, and coach a team while collaborating effectively with internal cross-functional groups, global partners, suppliers, and external customers. •You have proven experience managing operational and capital budgets (OpEx/CapEx), with a track record of driving cost-efficient laboratory operations and resource optimization. •Formal Operational Excellence certification (e.g., Lean Six Sigma Green/Black Belt, 5S, Kaizen). •Relocation assistance is available for this role. Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!