Independent Senior GMP Technical Reviewer

What you will do

• Review sampling coverage, evidence, applicable references and limits of conclusions.
• Challenge material findings and recommendations for consistency and feasibility.
• Document review comments and unresolved material differences before final reporting.

Mandatory requirements

• Verifiable senior experience in QMS, GMP-record or batch-release assessments relevant to pharmaceutical or biologics manufacturing.
• Independence from authorship of the findings reviewed and from the client controls being assessed.
• Ability to challenge evidence, references and severity and document technical differences clearly.
• Professional English for technical records, deliverables and stakeholder discussions.
• Availability for assigned on-site work in Manatí, Puerto Rico, with approved remote work where appropriate.
• Ability to meet confidentiality, site and information-handling requirements and disclose potential conflicts affecting independent assessment.

Necessary qualifications

• Typically 12 or more years of directly relevant professional experience, or a demonstrably equivalent track record.
• Exercise regulatory judgment and recognize sampling and evidence-access limitations.
• Evaluate recommended actions and effectiveness or closure criteria.
• Relevant quality, science or engineering education or equivalent senior compliance experience.

Desired qualifications

• Technical review of consulting reports or corporate GMP audits.
• Relevant interaction with regulatory authorities and applicable auditing credentials.
• Experience with the confirmed product type and working Spanish.

How to apply