Quality Assurance Lead – GMP & Compliance

Mentor Technical Group; San Germán (PR); On-site; USD 90,000 - 130,000; Full time

Job summary

Mentor Technical Group seeks a Quality Lead to oversee QA activities for a pharmaceutical maintenance system assessment in Puerto Rico. You will review QMS requirements, audit procedures, and regulatory compliance, guiding cross-functional teams across Engineering, Manufacturing, CQ, and Materials Management.

The role requires strong analytical and communication skills, experience with validation/verification, and bilingual English/Spanish proficiency.

Qualifications

• Bachelor’s or Master’s degree in Chemical Engineering, Pharmaceutical Technology, or a related scientific field.
• Proven experience with validation, qualification, and verification in a pharmaceutical manufacturing environment.
• Strong knowledge of current Good Manufacturing Practices (cGMP) and other regulatory requirements.
• Experience with Change Control processes and regulatory impact assessments, with cross-functional coordination.

Responsibilities

• Lead and coordinate Quality activities associated with the Maintenance System assessment.
• Assess applicable QMS requirements and compliance controls.
• Review maintenance procedures, workflows, and documentation practices.
• Evaluate CMMS use and Work Order documentation from a Quality and Compliance perspective.
• Assess governance, roles, responsibilities, and escalation processes.
• Review Change Management and Engineering Change Management processes.
• Evaluate interfaces between Engineering, Manufacturing, Maintenance, Operations, CQ, Quality, and Materials Management.
• Participate in interviews, process walkthroughs, and documentation reviews.
• Identify compliance gaps, risks, and improvement opportunities.
• Support the development and prioritization of corrective and improvement actions.
• Track identified observations and actions through completion.
• Provide Quality guidance to project stakeholders.
• Support preparation of assessment reports and management presentations.

Skills

Analytical skills

Problem solving

Communication skills

Bilingual English/Spanish

Regulatory knowledge

cGMP knowledge

Education

Bachelor’s or Master’s degree in Chemical Engineering, Pharmaceutical Technology, or a related scientific field

Tools

MS Office

Job description

Mentor Technical Group seeks a Quality Lead to oversee QA activities for a pharmaceutical maintenance system assessment in Puerto Rico. You will review QMS requirements, audit procedures, and regulatory compliance, guiding cross-functional teams across Engineering, Manufacturing, CQ, and Materials Management.

The role requires strong analytical and communication skills, experience with validation/verification, and bilingual English/Spanish proficiency.