Senior Manager, Microbiology (CVRM)

About the role

The Holly Springs Quality Control team at Roche/Genentech is looking for an experienced leader to establish and head its QC Microbiology team. The site is a $2B greenfield start-up producing CVRM (Cardiovascular, Renal, and Metabolism) medicines, with a planned launch in 2028. You will first focus on laboratory start-up and establishing core QC capabilities for facility, utility and process qualifications, then move to routine commercial operations after site licensure.

Key responsibilities

• Build a proactive quality culture based on psychological safety and transparent communication, and a safety culture based on Behavior-Based Safety principles
• Foster a high-performing lab culture through Lean Leadership, active coaching and continuous improvement
• Ensure appropriate staffing, resource allocation and workload balancing
• Partner with the global network to harmonize QC standards and ensure compliance across sites
• Establish KPIs focused on compliance, right-first-time execution and continuous improvement
• Author, review and approve technical, scientific and compliance documents such as test methods, validation protocols and SOPs
• Own QMS records including investigations, deviations, CAPAs and change controls
• Evaluate new technologies and use data to identify trends and mitigate risks
• Lead strategic QC projects and present microbiology topics during regulatory inspections, staying audit-ready

Required profile

• B.S. or M.S. in a science-related discipline with at least 8 years of experience in pharma/biopharma manufacturing, including 3+ years in QC at a finished drug product commercial site
• Proven technical leadership, project management and budget management (OpEx/CapEx)
• Exceptional communication and coaching skills, with experience working with internal groups, global partners, suppliers and customers
• Preferred: greenfield project experience and an Operational Excellence certification (Lean Six Sigma, 5S, Kaizen)

Required skills

• Microbiology methods, laboratory instrumentation and analytical method validation, qualification and transfer
• Contamination control strategies and environmental and utility system monitoring
• cGMP operations, ICH guidelines and FDA, EMA and other health authority requirements

What we offer

• Salary range of $120,100 - $223,100 depending on experience, qualifications and location; a discretionary annual bonus may be available
• Relocation assistance