Quality Manager

JLL•Juncos, PR

1d•Onsite

About The Position

JLL is seeking a Quality Manager to lead Quality Assurance, Compliance, Vendor Quality Management, and Quality Engineering activities for GMP-regulated pharmaceutical manufacturing operations. This role provides strategic and operational quality leadership for JLL-supported operations, including facilities management, cleaning, disinfection, sanitization, environmental monitoring, sampling, material handling, and pest control programs. The position is on-site in Juncos, PR and does not offer visa sponsorship. Candidates must be authorized to work in the United States without sponsorship. JLL is committed to hiring the best talent and empowering them to thrive, grow meaningful careers, and find a place where they belong.

Requirements

Strong knowledge of FDA cGMP regulations including 21 CFR 210 and 211.
Strong understanding of GDP and ALCOA principles.
Experience with Quality Management Systems (QMS), deviation management, CAPA systems, investigations, and audit readiness.
Experience developing and monitoring KPI dashboards and quality metrics.
Knowledge of vendor qualification, vendor governance, and subcontractor compliance management.
Experience in pharmaceutical manufacturing and GMP-regulated environments.
Strong analytical, technical writing, and root cause analysis skills.
Ability to independently assess compliance risks and escalate concerns appropriately.
Strong communication and leadership skills with ability to interface across all organizational levels.
Experience with systems such as Veeva, TrackWise, Maximo, Smartsheet, or equivalent quality/compliance platforms.
Bachelor’s degree in Science, Engineering, Quality, or related technical discipline.
5+ years of experience in pharmaceutical Quality Assurance, Compliance, or Quality Systems.
Candidates must be authorized to work in the United States without sponsorship.

Nice To Haves

7+ years of experience in GMP-regulated pharmaceutical manufacturing operations.

Responsibilities

Lead and manage the site Quality Management Program supporting GMP-regulated operations.
Provide independent Quality oversight for JLL operations, subcontractors, and vendor-managed services.
Manage and oversee minor and major deviations, investigations, root cause analysis, CAPAs, and effectiveness checks.
Monitor CAPA implementation, closure timeliness, effectiveness, and sustainability.
Develop, implement, and monitor quality metrics, KPI dashboards, trend analysis, and executive reporting.
Lead audit readiness initiatives and support internal, client, and regulatory inspections.
Perform operational walkthroughs, field observations, and quality oversight activities to verify procedural compliance.
Ensure compliance with SOPs, GDP requirements, ALCOA principles, and FDA cGMP regulations.
Develop and deploy quality awareness, training, and continuous improvement programs.
Support and oversee training programs related to quality systems, procedural adherence, documentation practices, and human performance.
Provide coaching, mentoring, and quality guidance to operations, vendors, and support personnel.
Oversee vendor governance activities including qualification, onboarding, compliance monitoring, annual reviews, and performance management.
Review and assess vendor performance trends, deviation patterns, and operational risks.
Interface directly with Amgen Quality, Operations, Engineering, EHS, and vendor leadership teams.
Lead quality risk assessments and recommend mitigation plans for operational and compliance risks.
Drive Quality Culture initiatives focused on Governance & Accountability, Continuous Improvement, Human Performance, and Operational Excellence.
Support quality-related change controls, procedural updates, and implementation of new operational processes.
Lead and facilitate quality review meetings, governance forums, and escalation discussions.
Ensure quality documentation and records are maintained in accordance with procedural and regulatory requirements.
Support implementation and oversight of quality systems associated with cleaning, sanitization, environmental monitoring, sampling, and pest control programs.