Sr. Manager, Manufacturing Execution Systems (MES)

Role: Senior Manager of Manufacturing Execution Systems (MES) leading digital manufacturing initiatives at a biopharma site. Responsibilities: develop MES strategy and governance, oversee lifecycle management including upgrades and compliance, ensure GMP, FDA, and data integrity standards, troubleshoot system issues, and drive continuous improvement through metrics and operational trends; lead cross-functional projects and support 24/7 manufacturing operations. Qualifications: Bachelor's in Biological Sciences, Engineering, or related field; 8+ years in manufacturing systems, MES, automation within regulated pharma or biotech environments; strong knowledge of GMP, FDA regulations, data integrity, and computerized systems; proven leadership in cross-functional project management and team development. Preferred: experience with digital transformation, validation, change control, audit readiness, and regulatory inspections for GMP systems. High-Value Details: Focus on digital transformation and manufacturing excellence in an onsite Durham, NC facility; role critical to manufacturing, Quality, MS&T, Engineering, and IT collaboration. No relocation support provided; role requires onsite presence.