S/4 Global Quality Lead supporting AstraZeneca's transition to one global ERP system including advising on GMP, GDP and other regulatory requirements for the new system and processes. Responsible for development and delivery of a transformational strategy within Quality for SAP S/4HANA. Identifies business change impacts and develops strategies to mitigate risk.

Manager of a dynamic Quality Assurance team supporting packaging operations at AstraZeneca. This includes oral solid dosage bottle and blister packaging for global markets.

Responsible for managing the site quality relationships for various contract manufacturing organizations the site supports via pharmaceutical manufacturing and packaging. Includes deviation authoring and approval, complaints, new regulatory requirement communications, issue resolution, supporting GMP requirements and various international quality needs.

Responsible for off-shift QA personnel/floor coverage including real-time record review and manufacturing and packaging deviation initiation. Single point of contact for site Quality CMO communications.

Responsible for off-shift QA personnel/floor coverage including real-time record review and manufacturing and packaging deviation initiation.

Specializing in handling regulatory requests, US and international regulatory health inspections (PMDA, ANVISA, EMA, ANSM and AIFA), supplier audits, IQ/OQ/PQ approvals, Process Validation compliance approvals, Cleaning Validation approvals, critical utility system (HVAC, water systems, compressed air) qualification and validation approvals, master batch record approvals, complaint investigations, SOP approvals and general Quality Assurance Compliance support.

Responsible for providing GMP QA oversite for deviations, CAPAs, and data release for the Biotechnology and Quality Control Laboratory at Covance. Includes management of the Quality Events Tracking process and metric trending along with Process Excellence projects.

Specialize in GMP Compliance and assist with audits, SOP approvals, and documentation review for the Biotechnology group

Responsible for GMP parenteral manufacturing technical support and author of deviations, CAPAs and trending documents. Trained in Root Cause analysis and Lean Manufacturing practices.

Research Experience/Techniques: PCR, RT-PCR, SDS-PAGE, Western Blot, Transformation, FTIR, cloning, plasmid transformation, cell culture, and various protein purification techniques.

Responsible for analysis of soil and water samples for specific elements and analytes.Instrument experience: LECO CHN analyzer, ICP - Atomic Emission Spectrophotometer, Konelab 20 Water Analyzer, HPLC