Lead GMP QMS and Batch Release Consultant

Weil Group Inc. | Manatí, Puerto Rico | Project-based consulting 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. Lead an independent pharmaceutical quality-system assessment and determine whether the records and controls supporting batch disposition are complete, consistent and defensible. What you will do Direct the assessment plan, sampling approach, multidisciplinary team and technical conclusions. Review batch records, release criteria and interactions with deviations, CAPA, change control, complaints and product quality review. Integrate evidence-based findings, a practical remediation roadmap and an executive readout. Mandatory requirements Personally led a comparable pharmaceutical or biologics GMP quality-system or batch-release assessment, with a verifiable individual contribution. Hands-on experience reviewing complete batch dossiers and Quality review, approval and disposition criteria. Ability to map findings to applicable FDA requirements, EU GMP and internal quality standards, distinguishing regulations, guidance and procedures. Direct experience with deviations, OOS or atypical results, CAPA and assessment of potential impact on other batches. Ability to defend evidence, risk classification and practical recommendations before senior Quality and operations stakeholders. 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 10 or more years of directly relevant professional experience, or a demonstrably equivalent track record. Apply quality risk management and pharmaceutical quality-system principles to practical improvements and effectiveness criteria. Lead cross-functional teams, define risk-based samples and document the scope and limits of conclusions. Relevant education in science, pharmacy, engineering or quality, or a demonstrated equivalent professional track record. Desired qualifications Experience with the product types and manufacturing technologies ultimately included in the project. Regulatory audits, inspection readiness or quality assessments for multinational pharmaceutical manufacturers. Quality-auditing credentials, advanced pharmaceutical quality training and working Spanish. Weil Group is proud to be an Equal Employment Opportunity Employer. #J-18808-Ljbffr