Senior Manager, Process and Compliance (Assembly and Packaging)

Welcome to Holly Springs, North Carolina— home to Genentech's largest-ever investment with an ambitious goal to be a fully connected Plant of the Future. This is where next-generation technology, capability, digital connectivity and Operational Excellence converge to create the global standard for high-volume, highly-efficient Drug Product manufacturing. This will include Component Prep & Compounding, Liquid PFS Filling, Automated Inspection, Autoinjector Assembly, Packaging/Finished Products. 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 will not only meet today’s demand for CVRM (Cardiovascular, Renal, and Metabolism) medicines but is a strategic commitment to be scalable with this portfolio, which serves one of the largest patient populations in the world. This is a fast-paced, highly entrepreneurial environment with a high-level of accountability from the site team to launch operations in 2028.

Are you a problem-solver and change agent who thrives in a High-Performing Team environment, eager to tackle the most complex manufacturing challenges? If so, this is a once-in-a-lifetime opportunity to not only launch a state-of-the-art facility from the ground-up but to 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're seeking a Senior Manager to lead the Assembly and Packaging Process and Compliance Team for the Apollo 11 project based at the Holly Springs site. The successful candidate will lead operational readiness, compliance, training and continuous improvement efforts for the Assembly and Packaging function at the Holly Springs facility. The position transitions from initial site startup strategy—focusing on SOP lifecycle, risk management, MES batch records, and operational and regulatory readiness—to post go-live leadership over deviation management, RCA, change controls, continuous improvement, metrics governance, and team development.

Key Start-up Responsibilities:

• You will oversee the authoring, review, and lifecycle strategy for manufacturing-centric standard operating procedures (SOPs), work instructions, and critical documentation for the Assembly and Packaging area.
• You will drive proactive risk management initiatives to identify operational risks and inefficiencies in new processes and establish strategic mitigation plans prior to operational impact.
• You will provide strategic oversight for the governance, validation, and approval framework of manufacturing batch records within the MES system.
• You will lead the strategy and framework for learning and technical capability development across the A&P team.