Independent Senior GMP Technical Reviewer

Weil Group, Inc; Manatí (PR); Hybrid; USD 110,000 - 150,000; Full time

Job summary

Weil Group Inc. is seeking an Independent Senior GMP Technical Reviewer to work on a project-based pharmaceutical manufacturing quality-system assessment in Manatí, Puerto Rico.

You will independently challenge technical support, risk classifications, and the practicality of material assessment findings before reports and recommendations are finalized. Responsibilities include reviewing coverage and evidence, ensuring consistency of conclusions, and documenting differences before final

Qualifications

• 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.

Responsibilities

• 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.

Skills

QMS experience

GMP knowledge

Independent assessment

Regulatory judgment

English proficiency

Education

Quality/engineering education

Job description

Independent Senior GMP Technical Reviewer

• Manati, PR
• Biotech/Pharmaceutical

Weil Group Inc. is identifying qualified consultants for a proposed pharmaceutical manufacturing quality-system assessment. This project-based opportunity is subject to project award and client confirmation.

Independently challenge the technical support, risk classification and practicality of material assessment findings before reports and recommendations are finalized.

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.

Weil Group is proud to be an Equal Employment Opportunity Employer.