Menirva Robil

• Lead management of the External Supplier Deviation Program and developing improvement opportunities where supplier deviation metadata is utilized to increase overall supplier compliance and mitigate risk
• Lead the External Supplier Audits Program (develop and execute the annual audit plan), develop and maintain supplier trending reports.
• Lead global supplier Pre-Approval Inspections (PAI) readiness by coordinating efforts across Quality Assurance, Regulatory Affairs, Supply Chain, and Manufacturing. Ensured compliance with international regulations (FDA, EMA, PMDA) and provided strategic risk assessments that alerted executive management to potential compliance gaps prior to inspections.
• Conduct supplier gap assessment and ensure that all supplier-related activities comply with applicable regulatory requirements, including FDA, EMA, PMDA, and other international guidelines
• Perform Supplier audits and reports, monitor industry trends, and support continuous improvement of supplier quality programs and documentation.

• Led the Internal Audit Program, including development of the annual schedule, audit execution, reporting, CAPA tracking, and auditor qualification management.
• Partnered with QA Leadership to implement and maintain GMP inspection readiness programs at global sites, including SME training, simulations, and inspection document readiness.
• Supported global health authority inspections, including FDA, EMA, PMDA, MHRA, ANSM, IGJ, and TMG, and contributed to GCP inspection readiness.
• Led the Quality Intelligence team, monitoring regulatory changes and escalating compliance risks to senior leadership.
• Collaborated cross-functionally to support high-impact investigations and strategic quality system enhancements.

• Supported the Supplier Quality Program, including audits, agreements, scorecards, and performance metrics.
• Owned the Internal Audit Program and monthly quality metrics reporting, driving system improvements through Veeva and cross-functional collaboration.
• Provided oversight of testing laboratories, resolving lab investigations and escalating critical issues.

• Reviewed batch records for commercial and clinical materials, including combination products (medical device and drug product), ensuring compliance with GMP and regulatory standards.
• Supported investigation of product complaints and ensured timely implementation and documentation of corrective actions.
• Responsible for QA metrics, Management Review monitoring, and preparation of Annual Product Reports.
• Developed and implemented testing protocols to ensure product compliance with industry standards.

Promoted from QC Supervisor to Compliance & Continuous Improvement Supervisor (QC).

• Supervised batch record data review and ensured timely product release in alignment with FDA and internal quality standards.
• Led laboratory investigations, internal audits, and Controlled Substance management.
• Owned QC KPIs and supported onboarding of new methods, instruments, and change controls.
• Provided technical leadership, mentored staff, and contributed to cross-functional process improvement initiatives.

• Acted as lead investigator for OOT/OOS lab results, deviations, and other non-compliance issues
• Executed CAPA action & trained staff on Behavior Based Compliance (BBC) to ensure root causes are identified.
• Developed new laboratory processes to improve quality compliance
• Led a 65 effort across Quality Control Laboratory and Create Mini Kaizen events to improve efficiency throughout the Quality Control Laboratory
• Lean and Six Sigma Black Belt Training and Certification: Reduce Quality Control Laboratory Expenses by 15% or more

• Performed and reviewed lab investigations as needed.
• Assisted in Internal/External audits, back room and front room support.
• Stability Coordinator and Stability Tracker Administrator.
• QA stability testing, raw material sampling, CofA sign off and in process/finished product disposition
• Performed analytical chemistry assays based on new and existing methodologies
• Promoted twice from junior roles

• Performed analytical testing on finished products, In-process and Cleaning Validation samples
• HPLC and dissolution testing of Solid dosage

• Performed analytical analysis on medical device (Drug -coated Stent), execution of stability study Protocols
• Performed elution using USP apparatus. Analyzed of elution as well as assay & impurities samples by HPLC