Sterility Assurance Lead, CVRM (Holly Springs)

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 Opportunity

We are seeking a highly motivated and experienced Sterility Assurance Director. This role is strategic and highly impactful, ensuring every patient benefits from medicines produced under the highest possible standards of quality and compliance. You will serve as the primary point of contact for Sterility Assurance at the site, partnering with MSAT, Operations, Quality, QC, Engineering, as well as Global teams, to ensure adherence to stringent standards. 

This critical role involves building the entire sterility assurance framework from the ground up, covering everything from design and commissioning through routine commercial operations. This ensures all processes, equipment, and facilities meet global regulatory requirements (FDA, EMA, etc.) and industry best practices, proactively embedding "sterility by design" into future work.

What You’ll Do

• Sterility Assurance Strategy Development: Support the establishment and implementation of the comprehensive Contamination Control Strategy (CCS) for the new facility, aligning to the global CCS standards and focusing on aseptic processing, sterilization methods, sanitization, and end-two-end facility design controls.

• Sterility by Design: Establish and implement robust sterility assurance standards (SOPs and standard work) throughout the business and operational activities. Drive continuous improvement by regularly assessing and refining processes and procedures to maximize efficiency and effectiveness.

• Design & Commissioning Phase: Review and approve facility and equipment design specifications related to aseptic processing zones, air classifications, and material plus personnel flows to ensure inherent to site wide contamination control strategy.

• Technical Expert & Problem Solver: Act as a subject matter expert and provide guidance on matters related to sterility assurance and environmental monitoring, monitoring data and trends and identifying areas for improvement 

• Root Cause Analysis: Lead complex microbiological investigations (e.g., sterility failures, high EM excursions, APS failures), determining root causes and ensuring the implementation of effective Corrective and Preventive Actions (CAPA).

• Training and Compliance: Develop and deliver specialized training programs for manufacturing and quality personnel on aseptic techniques, gowning qualification, and cleanroom behaviors.

• Materials Qualification: Establish requirements for the qualification of critical raw materials, components, and single-use systems to ensure compliance with microbiological specifications and cGMP requirements.

• Aseptic Program Leadership: Oversee the design, execution, and final approval of the Aseptic Process Simulation program, site Contamination Control Strategy and ensuring compliance with current Good Manufacturing Practices (cGMP) and regulatory expectations.

• Validation Oversight: Provide sterility assurance expertise for the qualification and validation of critical systems, including clean utilities (e.g., WFI, clean steam), sterilization equipment (e.g., autoclaves), isolators, and environmental monitoring systems. Oversee the development, qualification and validation of robust sterilization cycles for all manufac