- Quality Management System (QMS) SME
Description:
End-to-End QMS Review
- Map the end-to-end quality system as it relates to GMP record creation, review, approval, and archival
- Review core QMS elements and their interactions, including deviation/CAPA management, change control, document control, complaint handling, and product quality review
- Assess alignment of current-state processes and procedures with the BMS QMS Standard and applicable regulations (FDA, EU GMP, ICH Q7/Q9/Q10 as relevant)
GMP Records and System Interfaces
- Inventory the GMP records (electronic and paper/hybrid) and the systems that generate, store, or consume them (e.g., ERP/MRP, MES, LIMS, QMS/eQMS, warehouse management, and equipment/automation systems)
- Map the interfaces and data hand-offs between these systems, including any manual transcription, reconciliation, or bridging steps
- Evaluate data integrity and ALCOA+ compliance across these records and interfaces, including audit trail adequacy and review-by-exception practices
- Identify single points of failure, redundant or conflicting records, and reconciliation gaps that could affect the completeness or accuracy of the release package
Materials Traceability Review
- Assess end-to-end traceability of materials: incoming inspection and acceptance, warehousing, dispensing/kitting, in-process consumption, component/subassembly linkage, packaging, and finished-goods
- Evaluate forward and backward traceability (i.e., the ability to trace any material to all finished lots, and any finished lot back to all constituent materials, equipment, and records)
- Review controls for lot genealogy, material status control, segregation, and reconciliation of quantities
- Identify where traceability relies on manual controls and recommend system-based or automated controls to close those gaps
Batch Release Process Robustness and Quality Data Review
- Review the batch record review and disposition workflow end to end, including the criteria and evidence relied upon for the release decision
- Assess the quality review of data supporting batch disposition - the completeness, accuracy, and integrity of the records and system data reviewed, and how they are verified, reconciled, and cross-checked prior to release
- Evaluate the adequacy, consistency, and defensibility of the review process, including review-by-exception practices and the handling of discrepancies, exceptions, and out-of-specification/atypical results
- Benchmark the process against the QMS Standard and industry good practice, and recommend enhancements to ensure a robust, right-first-time release process
Gap Analysis, Recommendations, and Roadmap
- Document all findings in a risk-ranked gap analysis, mapped to the relevant regulation and QMS Standard clause
- Provide prioritized recommendations distinguishing immediate/quick-win actions from medium- and long-term remediation
- Deliver an implementation roadmap with suggested sequencing, dependencies, and indicative effort/resource considerations
Qualifications:
- Bachelor's Degree in Engineering.
- Minimum of 6 years of experience in direct pharmaceutical, medical device or biotechnology industries.
- Experience in direct process / manufacturing areas.
- Must be fully bilingual (English / Spanish) with excellent oral skills.
- Must be proficient using MS Windows and Microsoft Office applications.
- Strong knowledge in cGxP and regulatory guidance as well as understanding of how they are applied to regulatory compliance.
- Proven experience delivering QMS, data integrity, and batch-release assessments in FDA- and EU-regulated pharmaceutical, biologics, or medical-device manufacturing environments
- Demonstrated expertise in GMP records management, computerized system interfaces (ERP/MES/LIMS/eQMS), and materials traceability / lot genealogy
- Personnel with relevant regulatory and quality credentials and hands-on operational experience.
- Ability to work on-site at Manatí, Puerto Rico.
- Available to work extended hours, possibility of weekends and holidays.
