OPEX Manager

Laboratoire Guerbet•Raleigh, IL

6d•Onsite

About The Position

The Operational Excellence Manager operates in full compliance with applicable hygiene, safety, quality, and regulatory standards, and in alignment with the organization’s framework, company’s procedures, and the defined scope of responsibility the role is accountable for. The OpEx Manager is responsible for driving continuous improvement initiatives across the Raleigh manufacturing site to enhance operational performance, compliance, reliability, and cost efficiency. This role leads Lean, Six Sigma, and structured problem-solving efforts while ensuring alignment with GMP requirements, regulatory expectations, and corporate strategy. The OpEx Manager partners cross-functionally with Manufacturing, Engineering, Quality, Supply Chain, and Maintenance to improve safety, quality, delivery, cost, and people performance (SQDCP).

Requirements

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
Lean Manufacturing
Six Sigma / DMAIC
Statistical analysis tools
OEE analysis
TPM (Total Productive Maintenance)
Root Cause Analysis (RCA)
Project Management
Risk Management (FMEA)
Change Control systems
Data analytics and KPI dashboards

Nice To Haves

MBA or advanced technical degree
Experience supporting FDA inspections and remediation programs.
Experience with TPM (Total Productive Maintenance) and advanced equipment or asset performance optimization
Advanced statistical analysis skills and hands‑on use of analytics tools
Demonstrated ability to influence without direct authority in matrixed organizations
Prior experience driving enterprise‑level operational excellence or continuous improvement programs

Responsibilities

Develop and deploy the site Operational Excellence strategy aligned with corporate objectives
Lead Lean, Six Sigma, Kaizen, and TPM initiatives
Facilitate value stream mapping and waste reduction projects
Standardize best practices across manufacturing and support functions
Implement structured problem-solving methodologies (DMAIC, A3, 5-Why, Fishbone)
Establish and monitor site-level KPIs (OEE, Right First Time, deviation rate, PM compliance, backlog, cost per batch)
Lead tiered performance management systems (Tier 1–4)
Drive root cause analysis for recurring performance gaps
Develop visual management dashboards
Ensure continuous improvement initiatives maintain compliance with FDA / EMA regulations, cGMP standards, and Data integrity (ALCOA+ principles)
Support remediation plans, CAPA effectiveness, and audit readiness
Partner with QA to ensure sustainable compliance improvements
Lead cross-functional improvement projects from initiation to closure
Develop business cases for operational efficiency initiatives
Drive change management and stakeholder engagement
Ensure sustainable implementation with measurable results
Promote a culture of continuous improvement and accountability
Train employees in Lean tools and problem-solving techniques
Coach managers and supervisors in structured decision-making
Facilitate Gemba Walks and Kaizen events
Identify cost-saving opportunities without compromising quality or compliance
Optimize labor utilization and workflow efficiency
Improve asset reliability and reduce downtime
Support capacity planning and throughput improvements