Manager, GMP Cleaning Program and Projects Lead
$114,100–$138,267 year
On-siteDevens, Massachusetts, United States
Job Summary
Own end-to-end GMP Cleaning program ensuring SOP compliance and continuous inspection readiness while serving as the owner of Quality and Safety Events. Lead regulatory responses for FDA and internal audits, proactively identifying trends to prevent recurrence and driving timely, inspection-defensible investigations. Deliver campus projects managing scope, schedule, and compliance alongside vendor performance oversight to ensure audit-ready execution. Maintain inspection readiness through proactive risk identification and mitigation, ensuring GDP/ALCOA+ compliant documentation across operational records. Participate in cross-training activities and drive continuous improvement through KPI trending and process optimization within a fast-paced, highly regulated environment.
Required Qualifications
- Bachelor's degree in Engineering, Science, or related field
- 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
- Site-essential roles require 100% of shifts onsite at your assigned facility
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