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ProKidney Corp. · 2 months ago

Sr. Manager, Process Excellence

Winston-Salem, North Carolina, United States

Full-time

Onsite

Senior Level

5+ years exp

ProKidney is a company focused on driving efficiency and transformation within Operational Excellence. As a Sr. Manager, Process Excellence, you will lead cross-functional teams to enhance manufacturing performance through innovative process improvement strategies and digital technologies.

Health CareTherapeutics

No H1B

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

Qualification

GMP complianceProcess improvement methodologiesDigital manufacturing technologiesLean Six SigmaManufacturing operations managementProcess documentationData analyticsChange managementStrategic thinkingCommunication skills

Required

Bachelor's degree in Operations Management, Engineering, Life Sciences, or related field

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)

Strong analytical, strategic thinking, and change management skills

Executive presence with excellent communication skills across all organizational levels

Preferred

Master's degree or relevant certifications (e.g., Lean Six Sigma, PMP, CQE) preferred

Knowledge of Chain of Identity/Chain of Custody is a plus

Track record of inspection readiness and remediation is a plus

Company

ProKidney Corp.

ProKidney, a pioneer in the treatment of chronic kidney disease through innovations in cellular therapy, was founded in 2015 after a decade of research.

Founded in 2015

Salem, Oregon, USA

51-200 employees