OPEX Manager
On-site · Raleigh, North Carolina, United States
Job Summary
Operational Excellence Manager leads cross-functional Lean, Six Sigma, Kaizen, and TPM initiatives at the Raleigh manufacturing site to improve safety, quality, delivery, cost, and people performance. Drives continuous improvement in alignment with GMP/regulated standards, establishes and monitors site KPIs (OEE, Right First Time, deviation rate, PM compliance, backlog, cost per batch), manages structured problem-solving (DMAIC, A3, 5-Why, Fishbone), champions data-driven analytics, and partners with QA and other functions to ensure sustainable compliance and improvements. Responsible for project and change management, value-stream mapping, standardization of best practices, coaching of managers and supervisors, and fostering a culture of continuous improvement and accountability. Preferred qualifications include MBA or advanced technical degree, experience supporting FDA inspections, TPM, advanced analytics, and enterprise-level CI programs.
Required Qualifications
- Bachelor’s degree in Engineering, Life Sciences, Operations Management, or related field
- 7+ years of experience in pharmaceutical or biopharmaceutical manufacturing
- 3+ years of experience leading continuous improvement initiatives
- Strong knowledge of cGMP regulations
- Black Belt or equivalent certification
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