Senior Manager, Operations Support
Core
Provide technical leadership and strategic oversight for Operations Support across multiple manufacturing sites, leading process specialists to deliver business objectives, manage schedules, and drive continuous improvement in a biopharma/medical device environment.
Role type
Senior Manager, Operations Support (Manufacturing)
Builds
Manufacturing and Visual Inspection finite schedules, quality documentation (SOPs, CAPAs), and operational strategies for biopharma/medical device clients.
Domain
Life Sciences (Biopharmaceutical / Biotechnology) and Medical Device Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP industry experience, Process Engineering/Sciences, Manufacturing Operations, Technical Project Management, Quality, People Management, Root Cause Analysis, Data Analysis, Strategic Planning, Cross-functional Leadership
Preferred skills
Aseptic manufacturing experience, Large project leadership, Coaching and mentoring
Technologies
GMP, CAPA, Change Controls, SOPs
Responsibilities
Lead a team of process specialists to deliver business objectives; Develop and manage Manufacturing and Visual Inspection finite schedules; Plan and prioritize technical writing projects for investigations and quality systems; Lead investigations to drive resolution of deviations and root cause analysis; Establish and maintain key performance metrics for safety, quality, and productivity; Develop and implement continuous improvement strategies for manufacturing processes; Interpret manufacturing process data to drive data-driven decision-making; Serve as Subject Matter Expert during customer and regulatory audits; Interface directly with clients to ensure high customer satisfaction; Coach, mentor, and develop high-performing teams; Oversee professional development and performance reviews for direct and indirect reports.
Seniority
Senior Manager, hands-on leadership with 4-5 direct reports and 10-15 indirect reports