Senior GMP QMS & Batch-Release Lead — On-Site PR

Weil Group, Inc; Manatí (PR); On-site; USD 83,000 - 152,000; Full time

Job summary

Weil Group Inc. in Manatí, Puerto Rico, seeks a Lead GMP QMS and Batch Release Consultant for a project-based engagement.

You will lead an independent pharmaceutical quality-system assessment to determine if records and controls support batch disposition are complete and defensible. You will direct the assessment plan, review batch records, and integrate findings into a remediation roadmap with an executive readout for senior Quality and operations stakeholders.

Qualifications

• Requires experience applying GMP quality-system principles to practical improvements.
• Experience mapping findings to FDA/EU requirements and internal standards.
• Ability to lead risk-based sampling and document scope of conclusions.
• Strong written and spoken English for technical records/meetings.

Responsibilities

• Direct the assessment plan, sampling approach, multidisciplinary team and conclusions.
• Review batch records and release criteria, deviations, CAPA, change control, complaints and PQ review.
• Provide evidence-based findings with remediation roadmap and executive readout.

Skills

GMP Quality System

Quality risk management

Documentation review

Executive/stakeholder communication

Education

Science/Pharmacy/Engineering/Quality

Tools

Regulatory mapping (FDA/EU)

Job description

Weil Group Inc. in Manatí, Puerto Rico, seeks a Lead GMP QMS and Batch Release Consultant for a project-based engagement.

You will lead an independent pharmaceutical quality-system assessment to determine if records and controls support batch disposition are complete and defensible. You will direct the assessment plan, review batch records, and integrate findings into a remediation roadmap with an executive readout for senior Quality and operations stakeholders.