Regional Quality Manager - East

Description

• Lead Significant Events/Deviations investigations, review GxP Change Management processes, and provide quality training as needed to maintain compliance
• Execute JLL Quality Compliance programs including training verification, facility self-assessments, documentation control, personnel qualification files, and vendor/supplier audits
• Lead regulatory and quality assurance programs in GxP environments, ensuring all facilities services and documentation comply with JLL, client policies, and FDA cGMP regulations
• Coordinate and manage GxP vendors through qualification packages, audits, and service performance monitoring while drafting and executing client quality agreements
• Interface with client SMEs to ensure proper documentation and compliance with applicable regulations, international standards, and internal procedures
• Review GxP Work Orders, manage KPI scorecards, and participate in or lead internal and external audits while maintaining site audit readiness programs
• May require working in controlled manufacturing environments following strict safety and contamination protocols
• Occasional travel to multiple facility locations, vendor sites, or client meetings may be required
• Prepare and revise SOPs, change control documentation, investigations, CAPAs, and training materials while maintaining quality management systems like TrackWise

Requirements

• Ability to work independently with minimal supervision in a dynamic, fast-paced team environment
• Solid understanding of cGMP regulations as they relate to maintenance and repairs of drug manufacturing equipment and workplace environment control
• Frequent meetings, presentations, and client interactions requiring clear verbal and written communication
• Office and manufacturing facility environment requiring adherence to GMP safety protocols and procedures
• Minimum 4+ years of regulatory quality and statutory compliance experience in pharmaceutical or biotech environments
• Bachelor's degree in Engineering preferred, or equivalent quality engineering and production/facility operations experience
• Proven record of excellent internal and external customer service with demonstrated client relationship management skills
• Standard business hours with occasional extended hours during audits, investigations, or emergency response situations
• Experience participating in or leading Life Sciences Quality Councils or similar industry quality improvement initiatives
• Experience with risk analysis, business continuity planning, and emergency response procedures in regulated manufacturing environments
• Minimum 5+ years of experience in Pharma, Biotech, or similar life sciences sectors governed by GMP regulations working in Quality Assurance roles
• Knowledge of vendor qualification processes, audit management, and third-party service provider oversight in GxP settings
• Excellent verbal and written communication skills with ability to interface effectively with diverse technical and non-technical stakeholders
• Knowledge of Quality Engineering techniques, CMMS systems, and Quality Management Systems implementation and maintenance
• Strong commitment to quality assurance with proven ability to support and foster quality-first culture in organizational settings
• Advanced computer and office software skills with proficiency in quality management systems and documentation control
• Self-motivated and detail-oriented professional comfortable working independently with minimal supervision in team environments
• Regular computer use with advanced proficiency in office software and quality management systems
• Experience with quality management software such as TrackWise, MasterControl, or similar platforms for documentation and process control

Benefits

Training + Development

Interview process

Visa Sponsorship

Security clearance