Marie G. Email & Phone Number

Dublin, Ie

Vancouver, Bc, Ca

Responsible for the management and continuous improvement of the GCP vendor quality management program and processes including the development and management of the annual audit schedule; the supervision/conduct of vendor audits to assess the quality level and compliance with applicable GCP, GLP, and pre-commercial GVP regulations; and maintenance of all related audit records. Also responsible for supporting the vendor risk management and oversight processes including maintenance of the electronic supplier documentation system, key quality indicator performance reviews, and issue resolution.

Vancouver, Bc, Ca

Responsible for the management and continuous improvement of the GCP vendor quality management program and processes including the conduct of audits, which may include internal, clinical investigator sites, clinical vendors, CROs, TMFs, and other vendor audits to assess the quality level and compliance with applicable GCP regulations. Also responsible for supporting the vendor risk management and oversight processes including maintenance of the electronic supplier documentation system, key quality indicator performance reviews, and issue resolution.

Conshohocken, Pa, Us

Philadelphia, Pa, Us

Responsible for developing, creating, and implementing ERT's internal and vendor audit program. In the short time since joining, I have had a demonstrable effect on team productivity; metrics show almost doubled productivity from 2017 to 2018. Established metrics and measures of quality, reporting weekly to upper management. Enhanced existing metrics to increase granularity around audit findings to ensure that stakeholders and decision makers have appropriate information available to action findings.• Responsible for people management of a team of seven full-time auditors responsible for conducting internal and vendor audits. Experience managing remote personnel as well as collocated personnel.• Developing a set of benchmark capabilities for the internal and vendor audit team including regulatory and other standards (GCP, GMP, ISO 9001:2015, ISO 13485:2016, GDPR, HIPAA) to ensure consistent functioning of the team.• Working with Sourcing to improve strategic sourcing practices and incorporate consideration of regulatory risk into ERT's vendor management program.• Developing and implementing a risk-based model for creating the biennial audit schedule, while maintaining compliance with ISO 9001 and ISO 13485.

Blue Bell, Pa, Us

Responsible for regulatory and QMS process compliance for all technology programs at UBC globally, including periodic gap analysis for revised and/or new regulatory standards, to ensure continuous compliance. Responsible for SOP development, maintenance, and periodic review. Global responsibility for CAPA management for technology. Manager of a team of auditors responsible for internal and vendor auditing. Company subject matter expert for 21 CFR Part 11 and EU Annex 11, responsible for training on regulatory matters related to technology. Proven track record of quality assurance leadership: - Provided direction to technology arm of integration and separation initiatives related to UBC and Express Scripts, including providing direction on regulatory compliance.- Oversight led to a reduction in routine client audit findings across all projects; approximately a 33% reduction in the first year of her tenure. - Led initiative to reduce CAPA response time within UBC Information Technology; accomplished a 75% reduction in response time within 12 months. - Represented UBC information technology in client audits and regulatory inspections. No 483s received.Guided and provided counsel to corporate and business unit staff with regard to enterprise-wide and business unit procedures, policies, work instructions, guidelines, and training programs.

Exton, Pa, Us

Regulatory compliance: Directed multiple successful validation efforts for a local pharmaceutical client, addressing compliance to 21 CFR Part 11, EU Annex 11, GCP, and GMP. Partnered with team members situated globally (US, England, Ireland, Canada, Pakistan, Poland) to accomplish process needs and ensure audit and inspection defensibility.Quality Assurance: Responsible for defining, developing, and managing process documentation, including all policies, SOPs, work instructions, and templates required for a regulatory compliant cloud service offering. Also responsible for the maintenance of training records related to this documentation.Auditing and Remediation: Conducted an audit of existing procedures for a pharmaceutical-industry client, including all policies, standard operating procedures (SOPs), work instructions, and templates related to regulatory inspection observations. Provided and managed the client through a series of remediation steps to re-establish compliance. Responsible for leading a multidisciplinary project team through the controlled document development process, ensuring consistency and harmonization across the organization.

New York, New York, Us

Responsible for all aspects of vendor qualification audit program for Clinical Research & Development, including the development and implementation of process documentation (SOPs). Responsibility included establishing a global corporate approach to assessing regulatory compliance for vendors utilized in the conduct of clinical trials that was used to audit hundreds of vendors over five years. Responsibilities included the qualification, selection, and day-to-day management of a team of 10+ auditors, including training, ongoing performance management, and project management.Team Subject Matter Expert for computer systems development, testing, and validation; responsible for training Clinical Research & Development employees on principles of computer systems development and testing as well as auditing methods for computer systems used in FDA regulated industry.Participated in various internal quality improvement initiatives, including leadership and driving roles.

Responsible for corporate interpretation of, and compliance to, regulations including but not limited to 21 CFR Part 11 and Good Clinical Practice, as related to the use of technology. Conducted annual internal training on regulatory compliance as well as on-demand training throughout the year.Responsible for managing, monitoring and overseeing all computer system qualification and validation activities within the company, including custom-developed systems, commercial off-the-shelf software, and configured implementations of third-party software. Responsible for conducting quality audits internally as well as vendor and supplier audits for regulatory compliance and quality practices.Responsible for assessing and enforcing adherence to corporate SOPs, and for updating and communicating updates to the content of those SOPs when updates are required. Responsible for conducting retraining on SOPs and regulatory matters on an annual basis.

Us

Responsible for validation and quality assurance management, execution, and reporting for all phases of the software development lifecycle. Responsibilities included conducting requirements workshops; assisting in the authoring of functional and user requirements specifications; developing and enforcing quality assurance policies and procedures such as change control management and defect tracking; authoring quality assurance and quality control documentation, such as quality assurance plans, test plans, test scripts for all phases of testing, and completion reports; planning and managing test execution using a staff of up to ten test analysts; and managing and supporting the client-based validation effort. Worked directly with developers, project management, and client representatives on a regular basis.

Lawrence Township, Nj, Us

Responsible for automated functional and stress/load testing for the FI and CO modules of SAP. Utilized AutoTester and Mercury LoadRunner to author and execute automated test scripts; wrote custom DLLs to export data for audit defensibility.

Ba, History

Doctor Of Philosophy (Phd), Public Health / Epidemiology