Senior Manager, Microbiology (CVRM)

Roche•South San Francisco, CA

1d•$120,100 - $223,100•Onsite

About The Position

Welcome to Holly Springs, North Carolina— home to Roche/Genentech's largest-ever investment: a $2B greenfield start-up where next-generation technology, high-performing teams and Operational Excellence converge to create the global standard for high-volume, highly-efficient Drug Product manufacturing. The facility's core is defined by Innovation - leveraging advanced automation, robotics, digital tools, real-time data analytics, and simple, streamlined processes to produce the highest quality medicines. This plant meets today’s demand for CVRM (Cardiovascular, Renal, and Metabolism) medicines and is scalable to grow with the portfolio, which focuses on next-generation metabolic medicines specifically targeting the global obesity epidemic and Type 2 diabetes. This is a fast-paced, entrepreneurial environment with a high-level of accountability, with planned launch in 2028. Are you a problem-solver and change-agent who thrives in a Team environment, eager to tackle the most complex manufacturing challenges? If so, this is a once-in-a-lifetime opportunity to launch a state-of-the-art facility from the ground-up and shape the culture of our organization for the next generation. Join us in Holly Springs, where you won't just build a plant—you will build the future of medicine. The Holly Springs Quality Control Team is seeking an experienced and dynamic leader to establish and head our QC Microbiology team. In this critical role, you will build a highly effective and engaged organization capable of delivering safe, compliant, and efficient testing for our CVRM (Cardiovascular, Renal, and Metabolism) products manufactured at the Holly Springs site. Initially, you will focus on laboratory start-up activities—establishing core QC capabilities to support facility, utility, and process qualifications—before pivoting to routine commercial operations following site licensure.

Requirements

B.S. or M.S. degree (Science related discipline) with a minimum of 8 years of experience in pharmaceutical or biopharmaceutical manufacturing.
At least 3 years of direct experience in QC operations at a finished drug product commercial manufacturing site.
Extensive technical knowledge of Microbiology methods, laboratory instrumentation, and analytical method validation, qualification, and transfer within the pharmaceutical or biopharmaceutical industry.
Extensive experience in contamination control strategies, environmental and utility system monitoring.
In-depth working knowledge of cGMP operations, ICH guidelines, and global Health Authority regulatory requirements (FDA, EMA, etc.).
Proven technical leadership capabilities and demonstrated project management skills, with a track record of effectively managing workload distribution, timelines, and competing priorities.
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.
Proven experience managing operational and capital budgets (OpEx/CapEx), with a track record of driving cost-efficient laboratory operations and resource optimization.

Nice To Haves

Experience in a greenfield project.
Formal Operational Excellence certification (e.g., Lean Six Sigma Green/Black Belt, 5S, Kaizen).

Responsibilities

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).
Own Quality Management System (QMS) records, including investigations, deviations, CAPAs, and change controls.
Participate in the identification, evaluation, and implementation of new technologies in alignment with business objectives or regulatory requirements.
Use data-driven decision making to identify trends, mitigate risks, and improve operational performance.
Have responsibility for strategic projects to support execution of QC network strategy.
Present Microbiology topics during regulatory inspections and maintain a continuous state of audit readiness across QC operations.