
Posted 8 hours ago
Director, Global MES Lead
GileadDirector, Global MES Lead
Requirements
Bachelor's degree in Engineering or Life Sciences, 12+ years pharmaceutical manufacturing experience, Significant MES/EBR systems experience, Experience leading global MES initiatives, Knowledge of GMP requirements
Skills
MESGMP
About the role
Responsibilities
- Define and maintain the global MES strategy, roadmap, and operating model aligned with enterprise manufacturing and digital transformation objectives.
- Serve as the global business owner for MES and electronic batch records (EBR), managing platform direction and lifecycle management.
- Establish and govern global MES standards, design principles, and best practices for implementation and sustainment.
- Act as the primary MES business partner to Global Manufacturing, IT, Quality, and Supply Chain organizations.
- Provide business oversight for global MES delivery models, including deployment, validation, and sustainment in GxP environments.
- Ensure MES solutions meet global GMP, data integrity, and regulatory expectations.
- Drive digital manufacturing capabilities through integration with automation systems, ERP, and analytics platforms.
Requirements
- Bachelor's degree in Engineering, Life Sciences, or a related technical discipline.
- 12+ years of experience in pharmaceutical or biotech manufacturing environments.
- Significant experience with MES/EBR systems.
- Proven experience leading multi-site or global MES initiatives in regulated (GxP) environments.
- Strong understanding of Global Manufacturing, process engineering fundamentals, and GMP requirements.
Preferred Qualifications
- Experience with leading MES platforms such as Werum PAS-X or equivalent.
- Experience integrating MES with automation, historians, and ERP systems.
- Experience supporting health authority inspections, audits, and deviations related to MES.
- Experience across various modalities including biologics, cell therapy, API, or OSD.
- Demonstrated success influencing cross-functional, matrixed global teams.
About the Company
Gilead is a research-based biopharmaceutical company that has spent more than 35 years tackling diseases such as HIV, viral hepatitis, COVID-19, and cancer. We work relentlessly to develop therapies that improve lives and ensure global access to life-changing scientific innovations.
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Get started β it's freeDirector, Global MES Lead
Gilead Β· La Verne
