Member of the corporate JJRC Assessment and Remediation program designed to provide a cross-sector quality oversight for world-wide operations across the company and to escalate risks to the executive committee. JJRC performs full quality system audits against relevant J&J Policy and Standards, relevant GxP regulations and local procedures. An evaluation of Inspection Readiness is performed.• Auditing and Remediation of manufacturing sites from all 3 sectors; Pharmaceutical, Medical Device and Consumer Health Care• Auditing and Remediation of Country Marketing companies and associated Distribution Centers.• Auditing and Remediation of Corporate GMP Support groups.• Perform directed For-Cause audits and Special Investigations.• Perform External Manufacturing audits.

Provides oversight for the implementation and maintenance of multiple regulatory compliance functions supporting new and existing products worldwide. Manage compliance audit activities for GMP systems and processes related to highly specialized technologies.•Oversee the implementation and maintenance of quality systems, corporate standards and policies.•Interpret, execute and recommend modifications to organization policies and procedures.•Perform GMP and ISO compliance audit activities in highly specialized technical areas and processes critical to the manufacturing and control of medical products.•Provides expert technical and compliance support to Genzyme facilities for process improvements and preventive actions.•Interface with external regulatory inspectors to address compliance problems or issues.

Member of the worldwide compliance audit program to ensure product is developed, produced, controlled, and stored in conformance with current Good Manufacturing Practices (cGMP), and other applicable governmental regulations and guidelines.•Performed audits of human and veterinary drug manufacturing plants worldwide; drug dosage forms include biotechnology, vaccines, parenterals, tablets, liquids/ointments/creams, and active pharmaceutical ingredients (APIs)•Performed mock pre-approval inspections (PAIs)•Performed audits of distribution centers and warehouses•Assessed the adequacy of the corrective action commitments made in responses to audit observations•Tracked and verified the corrective actions after acceptance of the corrective action plan.•Tracked and verified the corrective actions and commitments that resulted from observations made by external regulatory bodies such as the FDA or EMEA•Wrote, reviewed, and approved level I and II corporate standards and global quality audit department procedures and guidelines

Managed a team of Auditors in the Corporate Quality Audit Department for inspections of cGMP service/material suppliers•Conducted audits of clinical and commercial drug and API manufacturers, laboratories, raw material suppliers, packaging and distribution sites•International audit experience and training from Qualified Persons•Drug products include tablets, capsules, and transdermals; including controlled substances •Managed PAI readiness for Shire and contract vendor sites and perform mock regulatory inspections. Assisted vendors during regulatory inspections•Completed audit reports and maintain Approved Supplier List•Managed the Internal Audit program for US Shire•Assisted in the negotiation of Quality Agreements•Experienced in the implementation of the Quality Management Modules in SAP

Managed a team of 13 QA inspectors for the in-process inspection of all production activities and the release of raw materials, components and finished goods.•Approved all quality documents within Clinical Services•Hosted customer and regulatory audits•Performed internal and external quality audits•Managed the implementation of quality system software (Trackwise, Documentum, Eduneering and JD Edwards)•Quality trainer, performing most quality and site training

Plant Auditor (2002)Ensured that all production processes and support functions were in compliance with federal regulations and corporate guidelines•Performed quality system audits of the manufacturing and laboratory areas•Reviewed and assessed completion of Consent Decree commitmentsR&D Lead Investigator (2001 – 2002)Responsible for investigating, documenting, tracking and trending manufacturing discrepancies.•Acted as liaison between Manufacturing and Quality Assurance•Wrote and revised change controls, work orders, SOPs and production batch records•Completed Consent Decree commitments and Gap AnalysisFormulation and Fill Supervisor (2000 – 2001)Oversaw all aspects of clinical vaccine manufacturing (Phase I-III)•Managed the aseptic formulation and filling of all clinical products•Supervised the inspection and packaging of all clinical products•Responsible for maintenance, calibration and validation of all equipment•Assisted with protocol development of new products entering the facility•Drafted and revised SOPs and BRs as needed to comply with the current GMPs•Experienced in lyopholization of products•Experienced in renovations of a formulation and filling suite to meet EU standards•Hosted Medicines Control Agency (MCA) auditShift Supervisor (1996 – 2000)Supervised 15 technicians during aseptic process of the Influenza Vaccine.•Performed and documented training for all employees.•Reviewed and approved all paperwork, reconciliation books and equipment logs.•Performed daily monitoring of all utilities of the production facility.•Assisted with the start-up of a new sterile vaccine manufacturing facility