Sahar Bahrani

Senior Quality Consultant

Sahar has more than 19 year progressive experience in the highly regulated medical device, biomedical, and pharmaceutical industries. She has vast experience in design, implementation, and sustainability of continuous improvement programs for 21 CFR and ISO 9001 compliant quality systems as well as cost reduction programs of product, process, and IT systems throughout a value stream at different stages of product lifecycle.  Her extensive expertise includes quality systems remediation and improvement strategies, Six Sigma, Lean implementation, business process re‐engineering,validation, CAPA, risk based investigations, recalls and field corrective actions, complaint handling, coaching, training, and cultural change, protein characterizations, analytical test method.  Sahar is also versed in project management and methodologies

 

EXPERIENCE…
  • Provided management consulting on quality and performance excellence, and coached multiple projects at medical device and pharmaceutical clients.
  • Directed the operations of recalls and field corrective actions for Baxter’s infusion systems Class I medical devices to address compliance and business challenges.  Led deployment Command Center of cross functional business teams and processes to ensure precise execution under challenging compliance situation closely monitored by regulatory agencies. Built exit strategy including a plan to address reconciliation of installed base devices to ensure accurate FDA reporting, organizing finished goods inventory to enable disposition strategy, and timetable to shut down deployment command center.  Worked closely with corporate attorneys, third party consultants, and OUS regions.
  • Established structured program to implement Baxter’s Business Excellence Model in the service organization.  The program encompassed implementing Lean Six Sigma, Baldrige, and Shingo award principles and practices to take operational performance to the next level.
  • Co-established Project Management Office (PMO) for Baxter’s quality organization to drive quality plan implementation, management reviews, metrics, and portfolio of quality improvement projects.
  • Led corporate Post Market Surveillance Quality Systems improvement program on complaint handling, Medical Device Reporting (MDR), and recalls improvement as part of overall quality transformation initiative.
  • Led high visibility continuous improvement compliance initiative on reference materials for immunodiagnostics assays. This initiative was launched to address unique challenges with Abbott diagnostics reference material’s selection, specifications, manufacturing, adjustment, testing, and stability, for both new and on‐market products
  • Ensured project plan execution against timelines by providing oversight of day‐to‐day reference material related issues including manufacturing, testing, specifications, failure investigations, CAPA, and quality improvements.
  • Ensured appropriate levels of staffing to meet project goals; managed a staff of 18 high‐level technical and quality professionals
  • Led the launch of division‐wide multi‐phase program (The ADD Passport Program) on CFR 21 Quality System Regulations training and culture change to enforce Quality System understanding and implementation.  The significant culture change resulted in quality and compliance understanding and practices, eliminating and avoiding the cost of poor quality.
  • Planned, implemented and maintained the Abbott Diagnostics Organic Operations Compliance Plan.  The plan intended to ensure compliance of the overall manufacturing process, purity, and stability of organic molecules and tracers used as key components in Abbott diagnostics kits.  It encompassed the assessment and remediation of fifty‐five organic rare reagents used across multiple diagnostics platforms.
  • Completed Analytical Instruments IQ/OQ/PQ and CFR Part 11 implementation.
  • Responsible for the technical conduct of Platform test methods and process validation studies.
  • Supervised experiments execution. Collected, organized, and analyzed data. Prepared validation protocols.
  • Wrote Standard Operative Procedures (SOPs), CAPA documents, and Change Requests, ensured compliance with Quality System Regulations, ICH Guidelines and Abbott policies and procedures.
  • Developed bioanalytical test methods to characterize Hepatitis/Retrovirus native viral proteins, recombinant viral proteins, polyclonal antibodies, monoclonal antibodies and synthetic peptides.
  • Bioanalytical expertise includes: SDS‐PAGE, Scanning densitometry, Protein amino terminal sequencing, Western blotting, Amino acid analysis, Reverse phase HPLC, Gel permeation chromatography HPLC, Peptide Mapping, Capillary Electrophoresis, and mass spectrometry.
  • Validated bioanalytical test methods and transferred to cGMP end user laboratories’ Hepatitis and Retrovirus operations teams.  Troubleshoot assays using variety of analytical methods.  Challenges included analysis of problematic conjugates, microparticles on resin peptides, vendor source material.
  • Wrote, coordinated and executed stability protocols for monoclonal antibodies and synthetic peptides.
  • Generated protein characterization data to support product submissions for regulatory agencies both domestically and internationally including INDs, PLAs, PMAs and ROW submissions for many ADD products.
  • Developed, characterized, and validated analytical test methods for Hepatitis/Retrovirus Rare Reagents.
POSITIONS HELD…
  • Senior Quality Consultant – BioTeknica, Inc.
  • Director of Operations – Baxter Healthcare
  • Senior Project Manager – Baxter Healthcare
  • Senior Project Manager – Abbott Laboratories                                                   
  • Technical Project Manager – Abbott Laboratories
  • Senior R&D Scientist – Abbott Laboratories
EDUCATION…
  • M.Sc., BioPhysical Chemistry – University of Baghdad, Iraq
  • B.Sc., Chemistry – University of Baghdad, Iraq
CONTINUING EDUCATION…
  • Project Management Training (PMI)
  • Lean Six Sigma (ASQ)
  • Medical Device Law Training/Food & Drug Law Institute (FDLI)
  • Quality Systems Training (AAMI)
  • Mass Spectrometry Analytical Chemistry (Northwestern University)
  • Molecular Biology Course (Catholic University)