Viatris

Director, Global Document and Change Management

Global Senior Manager, Document and Change Management

Currently oversee Change Control, Document Control (SOP and Site Master File), Manufacturing Batch and Packaging record review and issuance, Quality Compliance (laboratory specifications and methods adherence to Regulatory and Compendia requirements).  Previously oversaw Supplier Management and Quality/Technical Agreements and CAPA program. Active participate in numerous Health Authority Audits and participated in the remediation of FDA Warning Letter.

Senior Manager - Quality Compliance

Mylan

Managed the site CAPA program across multiple site departments (production operations, laboratory, maintenance and engineering and quality).  In addition, managed the site trending assessment program and assisted with the review of post market complaints.  Participated in Health Authority Audits through document requests, scribing and auditor interviews.

Manager, CAPA

Performed independent evaluations of quality systems and practices at Mylan sites across the network taking into considerations national and international regulations as applicable (FDA, EMEA, TGA, Health Canada, WHO, JP).  Assisted in the evaluation of global compliance metrics to determine trends and opportunities for continuous compliance and quality improvement.  Identified potential compliance risks and coordinated resolution.  Provided guidance on quality/compliance improvement as needed to assure sites are prepared for Health Authority inspections.  Prepared and maintained schedules, meeting agendas, and evaluation reports.  Prepared executive summaries and reports based on evaluations conducted.

Manager, Global Quality Compliance

Managed the Regulatory Quality Compliance group which entailed regulatory change control, quality control documentation and LIMS management.  Oversaw projects at various levels for compendia updates, laboratory and/or company initiatives, regulatory requests to ensure Mylan stayed in compliance with EU, JP, CA, AU, NZ, US, SUPAC, CFR, WHO and ICH regulations and guidelines.  Was the site liaison between Regulatory Affairs and Operations for the transfer of new product launches for the US, EU and CA.  Also, managed the quality review and approval of Manufacturing Process Validation and Laboratory Method Validation protocols and reports.  Participated in Health Authority Audits through document requests, scribing and auditor interviews.

Manager, Regulatory Quality Compliance

Managed the transfer of responsibilities of the change control system from Regulatory Affairs to Quality Assurance.  Implemented an external change control system that helps facilitate changes that affect Mylan's global subsidiaries and/or affiliates.  Assisted in the validation of an electronic SOP system within Documentum.  Worked with Mylan’s Quality Control Department to approve and implement a new LIM system utilizing LabWare.  Also assisted in the implementation of a Quality Operations cabinet within Documentum.  Participated in Health Authority Audits by working with document requests and auditor interviews.

Associate Manager, Quality Assurance Change Control

Regulatory Affairs Associate

R&D Chemist

Wyeth

QO Specialist

QO Chemist

Experienced Manager with a demonstrated history of working in the pharmaceuticals industry. Strong professional skilled in Good Document Practice (GDP), CAPA, Investigations, Change Control, Validation, GxP, and GMP.

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