I am a seasoned Quality Assurance professional with experience in a broad range of quality applications in the pharmaceutical, biological, dietary supplement and medical device industries. Experience implementing, monitoring and ensuring compliance with CFR parts 111,210, 211, 820, as well as CFR part 11. I am proficient in QSR, CMDR, ISO 9000/9001, ISO 13485 and other ISO standards. Experience managing CAPA, Product Quality Complaints, MRB, Supplier, Sub - contractor management and Deviations systems. I have extensive experience in conducting /leading both Internal and External cGMP/Quality Systems/PRE-PAI/Due Diligence Audits. I have also hosted inspections from State, Federal and International regulatory agencies. I have working experience with Trackwise, Pilgrim, SAP and Documentum systems.
Confidential, Chantilly, VA
Vice President of Quality Management
- Managed a staff of Quality Control and Quality Assurance professionals.
- Managed the transition to a Pharmaceutical Manufacturing Operation
- Leading the Confidential /Compliance aspects of the construction of a Confidential Pharmaceutical Manufacturing Suite.
- Developed Pharmaceutical Quality Systems, managed the qualification of all equipment and the commissioning of the facility.
- Managed the preparation of Quality related documentation for the NDA submission.
- Lead the preparation for and successfully completion of the PAI for the new Pharmaceutical Manufacturing Suite.
- Created Quality Manuals and Site Master Files for both the Dietary Supplement and Pharmaceutical Businesses.
- Created and issued Quality Agreements for Contract Clients and Suppliers.
- Responsible for the review and approval of all Confidential documentation relating to the facility, processes and products.
Confidential, Chantilly, VA
- Development and Approval of all SOPs
- Development and implementation of CAPA, Deviation, Change Control and Product Complaint Systems
- Development of Company Quality Manual and formulation of Company Quality Policy
- Provided Quality Management support for the development of product formulation, manufacture and packaging operations.
- Provided the inspection and release of Raw Materials, Components, In-process and Finished Product.
Confidential, Whippany, NJ
- Confidential is a Contract Packager of Pharmaceuticals, Dietary Supplements, Medical Devices and Cosmetics.
- Provided Quality Operations management for Quality Assurance Inspection staff in two locations on and over two shifts
- Provided mentoring to Quality Assurance Specialists and Inspection Staff
- Provided Quality over-sight to multi-functional teams in all phases of operations at Confidential
- Managed Quality Systems such as CAPAs, Complaints, Deviations, Non-conformances, Internal Audits, and External Audits
- Provided Confidential and function related to Quality and Operations staff.
Confidential, Wilmington, DE
Quality Management System Lead
- Maintain and improve QMS processes and procedures
- Manage CAPA and Calibration programs for site
- Serve as ISO13485 expert for site
- Manage the Internal and External Audit program
Confidential, Somerville, NJ
- Provided Quality Oversight for all Quality Systems related to the Clinical and Commercialization phases of the product lifecycle.
- Provided Statistical and Quality Support for validation, sampling, and design of experiment, testing, risk assessment and failure mode analysis.
- Responsible for the Quality out-puts of Third Party Manufacturers.
Confidential, Summit, NJ
Manager, Regional Quality Audits
- Conduct audits of Supplier facilities globally in order to assess their Quality Systems, Regulatory Compliance and capability to meet the product quality requirements of Confidential .
- Conduct audits domestically and internationally. Approximately 50% Travel
- Responsible for audit planning, execution and reporting for all audits assigned.
- Support eStars, the Global Supplier tracking system as System Administrator.
- Support Global Quality projects as assigned, i.e. Supplier Compliance with Melamine Guidance
Confidential, Whippany, NJ
Director of Quality Assurance and Regulatory Affairs
- Directed and coordinated all Quality Assurance and Regulatory programs and policies for Confidential a manufacturer of Spinal Disc Replacements Systems. Management Representative for FDA and other Regulatory Audits.
- Conducted Supplier and Sub-Contractor audits. Approximately 10% Travel.
- Managed Quality Systems including CAPA, SOPs, MRB, Change Control, Investigations, Calibrations, Supplier Qualification Audits, Quality Agreements and Quality Metrics.
- Developed Quality Plans for products in Development and Production.
- Performed Lot Review and Release.
- Lead the ISO process and extension of company Confidential
Confidential, Jupiter, FL
Quality Engineering Consultant
- Provided Quality Engineering support for Process Validation projects.
- Designed, conducted, and reported on process and equipment validations.
- Conducted Hazard Analysis, Process Mapping and provided Quality Compliance guidance to client organizations.
Confidential, Branchburg, NJ
Supervisor, Quality Assurance Product Disposition
- Responsible for the supervision of Production Record Review and Release process for Raw Materials, Buffers, Intermediates and Bulk Drugs manufactured at the Branchburg location.
Confidential, Lakewood, NJ
Manager, Quality Assurance
- Conducted Supplier/Sub-Contractor and Contract Laboratory audits.
- Project Manager for the conversion from RX to OTC and the subsequent re-introduction of that product.
- Developed Sampling Plans and Inspection Programs for a growing product line.
- Provided statistical support to Production and R&D.
- Managed Quality Agreements.
- Authored/Reviewed /Approved all Confidential Documentation generated by the company
- Direct contact with Regulatory bodies on the Local, National and International levels