Quality & Compliance Lead

JLL•Gurabo, PR

7d•Onsite

About The Position

This position serves as the primary driver for implementing, maintaining, and continuously improving Regional Quality & Compliance Programs across assigned sites. The role focuses on ensuring regulatory, procedural, and contractual compliance while maintaining Audit Readiness status and collaborating with site teams to achieve superior service levels and contractual scoring metrics. The specialist interfaces directly with client quality units through established Master Quality Agreements and develops a quality-first culture within FDA-regulated manufacturing environments.

Requirements

Bachelor's degree with minimum 6 years of experience in quality/compliance programs for pharmaceutical/biotechnology/medical devices facilities
Thorough understanding of cGMPs as they relate to facilities, utilities, equipment, and laboratories supporting pharmaceutical manufacturing
Strong knowledge of FDA guidance documents and regulations including 21CFR parts 11, 210, 211, 600, and 820
Proven expertise in Quality Management Systems including Investigations/RCA, CAPAs, Audit programs, and Document Management
Excellent PC skills with proficiency in MS Office applications, particularly Excel, Word, and PowerPoint
Excellent oral and written communication skills for interfacing with all management levels and diverse customer base
Demonstrated ability to work independently while effectively leading and mentoring team members
Candidates must be authorized to work in the United States without sponsorship.

Nice To Haves

EIT (Engineer in Training) or PE (Professional Engineer) certification
Working knowledge of Quality Management Software such as TrackWise, Success Factors, Infinity, or Veeva
Experience with ISO 9001:2015 Quality Management System implementation and maintenance
Background in vendor qualification processes and quality agreement management
Familiarity with change control processes and document management systems in regulated environments
Previous experience in audit preparation and regulatory inspection readiness
Strong analytical skills for recognizing non-compliance trends and patterns in quality data

Responsibilities

Develop, implement, and support quality programs including Non-Conformance Investigations, CAPAs, Training Compliance, and Vendor Qualifications
Build and maintain successful relationships with account personnel and client stakeholders to promote confidence and best practices
Interface with client quality personnel to ensure all requirements are followed and work is properly documented and recorded
Perform and support audits while preparing documents and training materials for site staff performance enhancement
Manage and report on Quality and Compliance critical performance measurements and develop status reports for Quality Programs
Lead staff through clear communication of expectations, accountability, and continuous improvement performance feedback
Ensure JLL's Life Sciences Quality Management System implementation including ISO 9001:2015 requirements compliance