Independent Consultant  Conducted remote Quality and Manufacturing Audits of 3rd party suppliers aseptic operations in Europe, Saudi Arabia and the US. Performed due diligence review of selected QA/RA aspects associated with pharmaceutical company business acquisition planning and due diligence auditing. Assessed the calibration and preventive maintenance functions and assisted in remediation tasks based on the assessment in support of FDA ongoing inspection. Provide FDA liaison services to company in connection with ongoing IDE pre-submission discussions with FDA for designation of the Polyclonal Antibody protein as a Class I exempt IVD device product. Prepared SOPs for QSM for a Medical Device virtual company, including Design Controls, Design History File. Personnel Training and Quality Manual. Created User Requirements Specifications (URS) / Design Specification (DS) procedure for the validation of company spreadsheets. Establish the end user, functional, and design requirements. Include general requirements and Customer-specific calculations / definitions. Created and applied the URS / DS to spreadsheets for use in the dispensing laboratory for calculation of API for compounding. Drafted a position paper supporting a roadmap and a rationale for replacing the current manual inspection process with a semi-automated inspection process. Leveraged industry position papers (e.g. PDA, USP, Knapp) and regulatory guidance to justify the transition. Performed statistical assessment to establish limits for visual inspections for 503B Outsourcers.  Prepared Position Paper on current industry and regulatory practices and guidance for the acceptability and controls for manufacturing potent compounds (Cytotoxics, hormones, steroids etc.) in a common facility with non-potent pharmaceutical product.

Responsible for both the technical and business aspects of a company specializing in providing quality, compliance and regulatory support services, including validations and quality system consulting support to the FDA Regulated Industry. Served as principle responsible for directing and implementing strategic quality system solutions and regulatory affairs support to clients within the Pharmaceutical industry. Directed regulatory support services group responsible for development of CMC content to support over 75 IND, ANDA, NDA (505(b)(2)) regulatory submissions in eCTD format via the FDA Electronic Submission Gateway (ESG), including maintenance of the ongoing life cycle management of submitted dossiers. Performed FDA inspection readiness audits in preparation of regulatory cGMP, Quality System (QSIT) and PAI inspections in US, Europe and India. Performed site readiness inspections in preparation of FDA audits for the Medical Device Industry. Prepared and delivered cGMP training programs covering cGMP regulations training, QSIT, OOS training, SOP training, QC/QA training, Analytical QC/QA training, statistical program training, compliance audit training and process validation training for industry and educational groups. Served as lead quality auditor for cGMP audits of API manufacturers in the US and Mexico and Finished Product manufacturers in China, South American, Europe and India.  QbD Trainer, skilled with demonstrated expertise in statistical analysis including application of SAS-Jmp, for establishing and implementing quality by design programs in compliance with ICH Q8, Q9 and Q10.

Served as Lead Project Manager for drug development activities for twenty (20) abbreviated new drug applications. Responsible for the management of a cross-functional team in a matrix organization including the initial identification of lead compounds, sourcing of raw materials, formulation and analytical test method development, technical transfer, validation, through regulatory submission, FDA approval and market launch.Implemented computerized project tracking program (Microsoft Project) for the planning and monitoring of all development activities involved in submission of INDs, ANDAs and NDAs.

Coordinated the activities of a 32 member Quality Control Group in Multisource Pharmaceutical Division with $2.2 million annual budget. Responsible for Raw Material, In-Process and Finished Product testing as well as Stability Program.  Established Documentation and Compliance Group to address Regulatory and cGMP issues. Established Method Validation group to address GMP issues. Established tightened manufacturing specifications for all product release testing. Developed and installed a Laboratory Information Management System (LIMS) for the purpose of scheduling, tracking and reporting all analytical results.  Served as System Administrator for a 20 user Network handling all QC/QA Documentation. Served as Company on-site Liaison to FDA Investigators during inspections and reviews. Awarded Company Outstanding Manager Award.

Supervisor – Analytical Support, New Sweetener DevelopmentSupervised analytical chemistry group providing support to 14 synthetic organic chemists involved in new compound discovery.  Developed new methodology involving all aspects of HPLC including Ion and Chiral Chromatography.  Designed and implemented specific protocols to investigate stability, purity, solubility and structural identification of unique classes of synthetic organic compounds.

Performed non-routine chemical testing, method development and validation in support of all Pfizer divisions. Demonstrated expertise in analytical chemical analysis methodology including chromatographic, spectroscopic, electrochemical and wet chemical procedures. Developed designed experiments (DOE) for the execution of characterization and validation of analytical testing for a broad range of chemical entities including both small and large molecules.