OPEX ManagerWHAT WE ARE LOOKING FORThe 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 Operational Excellence (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).
YOUR ROLEContinuous Improvement Leadership- 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)
Performance Management & KPIs- 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
Regulatory & GMP Alignment: - Ensure continuous improvement initiatives maintain compliance with:
- FDA / EMA regulations
- cGMP standards
- Data integrity (ALCOA+ principles)
- Support remediation plans, CAPA effectiveness, and audit readiness
- Partner with QA to ensure sustainable compliance improvements
Project & Change Management- 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
Culture & Capability Development- 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
Cost & Productivity Optimization- 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
YOUR BACKGROUNDRequired 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
Preferred Qualifications- 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
Technical Competencies- 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
