Senior Manager, Microbiology (CVRM)

Location: Holly Springs, North Carolina, United States of America. Relocation assistance is available.

Salary: $120,100–$223,100 annually, plus a discretionary annual bonus based on individual and company performance.

Company

hirify.global, a member of the Roche group, develops medicines for serious and life-threatening diseases through biotechnology and scientific research.

What you will do

• Establish and lead the microbiology QC organization for CVRM drug product manufacturing.
• Build core laboratory capabilities for facility, utility, and process qualification, then transition to routine commercial operations after site licensure.
• Develop staffing plans, allocate resources, balance workloads, and foster a high-performing laboratory culture through coaching and Lean Leadership.
• Define KPIs focused on compliance, Right-First-Time execution, and continuous improvement.
• Author, review, and approve test methods, validation protocols, SOPs, and other technical and compliance documents.
• Own investigations, deviations, CAPAs, change controls, strategic QC projects, and regulatory inspection readiness.

Requirements

• B.S. or M.S. degree in a science-related discipline.
• At least 8 years of experience in pharmaceutical or biopharmaceutical manufacturing, including 3 years in QC operations at a finished drug product commercial manufacturing site.
• Extensive knowledge of microbiology methods, laboratory instrumentation, analytical method validation, qualification, and transfer.
• Experience with contamination control strategies and environmental and utility system monitoring.
• In-depth knowledge of cGMP operations, ICH guidelines, and global health authority requirements, including FDA and EMA standards.
• Technical leadership, project management, budget management, communication, coaching, and cross-functional collaboration experience.

Nice to have

• Experience with a greenfield project.
• Operational Excellence certification such as Lean Six Sigma Green or Black Belt, 5S, or Kaizen.

Culture & Benefits

• Work in a $2B greenfield facility using automation, robotics, digital tools, and real-time data analytics.
• Participate in the launch of a state-of-the-art manufacturing site planned for 2028.
• Build a culture based on psychological safety, transparent communication, personal accountability, and continuous improvement.
• Receive relocation assistance for the role.