Sr. Manager, Process Excellence
ProKidney Corp.
Winston-Salem, NC
Manufacturing / Production, Business Management / Project / Planning
Position Summary:
As an Sr. Manager, Process Excellence, you will play a strategic role in driving efficiency, compliance, and transformation within Operational Excellence. You will guide cross-functional teams across manufacturing operations, fostering a culture of innovation, continuous improvement, and operational excellence. Leveraging your expertise in GMP compliance, process improvement methodologies, and digital manufacturing technologies, you will elevate manufacturing performance and drive strategic initiatives.
Responsibilities:
Applicants must be eligible to work in the United States without the need for work visa or residency sponsorship.
As an Sr. Manager, Process Excellence, you will play a strategic role in driving efficiency, compliance, and transformation within Operational Excellence. You will guide cross-functional teams across manufacturing operations, fostering a culture of innovation, continuous improvement, and operational excellence. Leveraging your expertise in GMP compliance, process improvement methodologies, and digital manufacturing technologies, you will elevate manufacturing performance and drive strategic initiatives.
Responsibilities:
- Develop and implement innovative process improvement strategies, leveraging digital technologies and GMP best practices to enhance efficiency and compliance.
- Collaborate with cross-functional teams to assess and execute strategies that enhance process efficiency, reduce costs, and improve overall performance, align to organizational objectives.
- Develop and maintain comprehensive process documentation (SOPs, process maps, work instructions, RACI).
- Lead change management initiatives to support adoption of new processes and technologies.
- Stay current on industry advancements, best practices, and emerging trends in manufacturing operations management.
- Proactively identify opportunities for optimization, cost reduction, and value creation.
- Identify opportunities for digital transformation within manufacturing operations (automation, data analytics, and tool integration).
- Utilize data analytics and KPIs to monitor performance and identify trends, compliance issues, and improvement opportunities.
- Produce clear reports and insights for senior leadership to inform strategic decisions and provide visibility into manufacturing performance.
- Communicate effectively at all levels, translating complex concepts and strategies into actionable objectives.
- Foster a culture of openness, transparency, and collaboration across manufacturing operations.
- Bachelor’s degree in Operations Management, Engineering, Life Sciences, or related field. Master’s degree or relevant certifications (e.g., Lean Six Sigma, PMP, CQE) preferred.
- Minimum of 5 years of experience in manufacturing operations management, GMP compliance, process improvement, or related roles in a regulated environment.
- Strong knowledge of GMP regulations and regulatory compliance requirements.
- Expertise in Operational Excellence and continuous improvement methodologies (Lean, Six Sigma, VSM, DMAIC).
- Proficient in process documentation, mapping, and RACI frameworks (SOPs, WI).
- Familiarity with autologous aseptic manufacturing and cleanroom operations.
- Proficiency with manufacturing digital technologies (ERP, MES, LIMS) and process analytics tools (Excel, Visio, data visualization software).
- Knowledge of Chain of Identity/Chain of Custody is a plus.
- Track record of inspection readiness and remediation is a plus.
- Strong analytical, strategic thinking, and change management skills.
- Executive presence with excellent communication skills across all organizational levels.
Applicants must be eligible to work in the United States without the need for work visa or residency sponsorship.
About the company
Construction, Software Development, IT Services and IT Consulting
ProKidney, a pioneer in the treatment of chronic kidney disease through innovations in cellular therapy, was founded in 2015 after a decade of research. ProKidney’s lead product candidate, rilparencel (also known as REACT®), is a first-in-class, patented, proprietary autologous cellular therapy being evaluated in Phase 2 and Phase 3 studies for its potential to preserve kidney function in diabetic patients at high risk of kidney failure. Rilparencel has received Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA. For more information, please visit www.prokidney.com.