What this job involvesThis 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.
Your day-to-day tasks will include:• 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
Required Qualifications:• 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
Preferred Qualifications:• 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
This position does not provide visa sponsorship. Candidates must be authorized to work in the United States without sponsorship.
Location:On-site -Gurabo, PR
If this job description resonates with you, we encourage you to apply, even if you don't meet all the requirements. We're interested in getting to know you and what you bring to the table!
Personalized benefits that support personal well-being and growth:JLL recognizes the impact that the workplace can have on your wellness, so we offer a supportive culture and comprehensive benefits package that prioritizes mental, physical and emotional health. Some of these benefits may include:
- 401(k) plan with matching company contributions
- Comprehensive Medical, Dental & Vision Care
- Paid parental leave at 100% of salary
- Paid Time Off and Company Holidays
- Early access to earned wages through Daily Pay
At JLL, we harness the power of artificial intelligence (AI) to efficiently accelerate meaningful connections between candidates and opportunities. Using AI capabilities, we analyze your application for relevant skills, experiences, and qualifications to generate valuable insights about how your unique profile aligns with the specific requirements of the role you're pursuing.
