Mary Campbell

About Mary Campbell

Seasoned Pharmaceutical Quality Assurance/Regulatory Compliance Professional with over ten years’ experience in the industry coupled with ten years’ experience in Materials/Supply Chain Management. Experience within diverse environments such as start-up, virtual, CRO/CMO/CPO, OTC and Rx commercial pharmaceutical companies. Consulting experience with companies operating under Consent Decree and responding to FDA 483s. Key player in creating, implementing, and managing multiple programs within the realm of Quality Assurance and Regulatory Compliance, some of which include- Created and managed cGMP Training Programs; authored and approved SOPs in response to FDA 483 - Created and managed APR/PQR Program in response to FDA 483 - Created Retain/Reserve Sample Programs in response to FDA 483 - Implemented Supplier Quality Programs, including Quality Agreement negotiations, Business Continuity Planning, Targeted Improvement Plans (TIPs) for company under Consent Decree - Managed Quality Events, such as Quality Investigations, Deviations, OOS (as written by laboratory management personnel), and implementing associated CAPAs, as warranted utilizing Ishikawa Fish Bone(Cause and Effect) Diagrams, Fault Tree Analysis, and other applicable methods - Led cross-functional teams to identify and implement CA/PA as identified- Assisted with internal and external auditing functions. Wrote and reviewed audit reports and identified any possible “weak links” in Supplier Quality Program - Compiled Monthly quality metrics and reporting utilizing Excel. Identified overdue Change Controls, Quality Events, documentation, and any Change-related process and escalated said information to Senior Management - Managed MRP II Implementations and instituted Master Planning/Demand Management Programs- Worked on regulatory ANDA submissions, CMC/Annual Reports, CBE\'s, etc; Familiar with FDA SPL HL7 Labeling via third party software

Experience

1. Supplier Quality Management Auditor

   Advanced Therapies, Llc

   Apr 2019 — Present · Philadelphia, PA, US

   Represents QA Compliance in new product development and client initiatives to ensure proper supplier selection and approval processes are followed; maintain Approved Supplier List\' review and approve new suppliers; audit current and new suppliers; work with manufacturing, supplier, and technical operations for supplier quality related issues (SCARs); revise SOPs related to Supplier Qualification and Auditing; initiate new SOPs as applicable; maintain supplier performance metrics; create, update and manage annual audit schedule, perform on site and desk audits of suppliers, create and approve SOPs, forms, and templates.

Education

• West Chester University of Pennsylvania

  Music Education, Music Teacher Education

  1976 — 1980

• Immaculata University

  Economics, Business/Managerial Economics

  1980 — 1989

• Holy Family University

  PreMed, Lifesciences

  1993 — 1995