OPEX Manager

At Guerbet, we build lasting relationships so that to enable people to live better. This is Our Purpose.

We are a global leader in medical imaging, offering an extensive portfolio of pharmaceuticals, medical devices, digital and AI solutions, for diagnostic and interventional imaging. As a pioneer in the field of contrast products since the last 95 years ,we continuously innovate. We dedicate 10% of our revenue to Research & Development such as to improve the diagnosis, prognosis and quality of life of patients.

Achieve, Cooperate, Care and Innovate are the values ​​that we share and practice on a daily basis.

Working at Guerbet is not only being part of a multicultural team of 2,600 people across more than 20 countries, but, it is above all about playing a unique role in the future of medical imaging.

For more information on Guerbet, go to www.guerbet.com and follow Guerbet on Linkedin, Twitter, Instagram and Youtube

WHAT WE ARE LOOKING FOR

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 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 ROLE

Continuous 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 BACKGROUND

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

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

Reason to join US

Much more than a Competitive salary,

We offer continued personal development. When you join Guerbet, you :

• Are choosing a global leader with recognized expertise in diagnostic and interventional imaging, 


• Are joining our 2820 collaborators who are committed every day to offering innovative solutions to improve quality of patient’s life all over the world,


• Are joining a company where we value diversity of talents coming from various horizon.

We # Innovate # Cooperate # Care #Achieve at Guerbet. 

Guerbet is an Equal Opportunity Employer. As an organization, we believe that no individual should be discriminated against because of their differences, which includes the following: age, disability, ethnicity, gender, gender identity and expression, religion, or sexual orientation. All employment decisions shall be made without regard to age, race, creed, color, religion, sex, national origin, ancestry, disability status, veteran status, sexual orientation, gender identity or expression, genetic information, marital status, citizenship status, or any other basis as protected by federal, state, or local law. Guerbet is committed to diversity, equity, and inclusion.

Guerbet provides accommodations to applicants and employees with disabilities. If you need an accommodation to apply for a position please send an email to [email protected] or you can also call this number +19843443717