Manager, GMP Cleaning Program and Projects Lead
Principal Objective Of The Position
Ensure safe, compliant, and inspection-ready GMP facility operations through end-to-end ownership of GMP Cleaning programs, Quality and Safety Event management, regulatory response execution, and delivery of facility-driven projects.
Drive sustained compliance by integrating operational execution, data integrity, continuous improvement, and risk management across all GMP cleaning, infrastructure, and supporting systems.
Major Duties and Responsibilities
Own end-to-end GMP Cleaning program (cleaning, disinfection, data integrity) ensuring SOP compliance and continuous inspection readiness
Serve as owner of Quality Events (deviations, CAPAs, change controls) and Safety Events, driving timely, inspection-defensible investigations and sustainable corrective actions
Lead and author regulatory responses (FDA/internal audits) and proactively identify trends to prevent recurrence
Deliver campus projects (scope, schedule, compliance, change control/validation as applicable)
Ensure integration of GMP cleaning requirements with facility design, construction, and maintenance activities
Maintain inspection readiness through proactive risk identification and mitigation (compliance gaps, data integrity risks) and lead audit preparation/SME support
Participate in cross-training activities within department organization
Ensure GDP/ALCOA+ compliant documentation and alignment across Maximo, Quality systems, and operational records
Drive continuous improvement through KPI trending, audit insights, and process optimization
Knowledge and Skills
- Bachelor’s degree in Engineering, Science, or related field (or equivalent experience)
- 2–5+ years of experience in GMP manufacturing, facilities, or Quality Compliance environments
- Experience in GMP cleaning, data integrity (GDP / ALCOA+), and regulatory expectations
- Demonstrated ability to manage multiple complex programs and projects simultaneously
- Strong understanding of facilities operations and infrastructure within GMP environments
- Knowledge of EHS/OSHA requirements and safety program integration
- Effective leadership, communication, and cross-functional collaboration skills
- Ability to operate independently in a fast-paced, highly regulated environment