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Company

Worldwide Clinical Trials · 11 hours ago

Senior Director QA Audit and Inspection Program

United States

Full-time

Remote

Director/Executive

10+ years exp

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Health CarePharmaceutical

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Hiring Manager

Monique H.

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Responsibilities

Act as the QA Global head for the QA Audits & Inspections reporting directly to the EVP Global Head of Quality

Plans, adjusts, manages and optimizes all resources (budgets, staff and technologies) for the advancement of the QA’s goals and objectives for the Audit & Inspection Program

Oversees, monitors and reports on all internal and external QA audits to ensure timely completion of applicable CAPAs to prevent reoccurrence and to drive process improvements

Defines, monitors, tracks and reports Key Quality Indications (KQI) and Quality Tolerance Limits (QTL) for the Audit & Inspection Program

Oversees the management, planning, hosting, reporting, documentation and follow up of all GCP Regulatory Inspections and Sponsor audits

Serves as the Subject Matter Expert on QA Quality Management Processes for Audits and Inspections

Qualification

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QA Audit ManagementGCP Quality Management SystemRegulatory ComplianceClinical Research PrinciplesRisk Management StrategiesFDA BIMO InspectionsGCP InspectionsICH GuidelinesGxP ActivitiesAudit Types Experience21 CFR Part 11Drug Development ProcessBudget ManagementMicrosoft ApplicationsEnglish Fluency. in Science10+ years GCP experienceProject ManagementCollaboration Skills

Required

Demonstrates excellent organizational leadership competences, inclusive of scheduling and leading team meetings that are effective, efficient and documented

Demonstrates excellent project management and decision-making skills

Communicates professionally, concisely, clearly and consistently to external and internal customers both verbally and in writing

Demonstrates an excellent understanding of clinical research principles and processes for clinical trials

Demonstrates ability to work collaboratively with cross functional stakeholders to drive process improvements based on Quality Indicators

Demonstrates the ability to implemented risk management strategies

Previous experience with leading/participating in FDA BIMO inspections, MHRA GCP inspections, Health Canada GCP inspections, EMA GCP inspections, and other international Regulatory inspections is required

Excellent understanding of the principles for a GCP Quality Management System

Excellent working knowledge of ICH Guidelines, FDA regulations, European Directives, MHRA Statutory Instruments, AIFA CRO Decree

Possesses broad experience related to understanding the principles and application of quality and regulatory compliance related to GxP activities, specifically GCP

GcLP, GLP, GVP, GPP, Device and GMP knowledge required

Previous experience in preparing an organization for GCP Regulatory Inspection and being the primary lead of GCP Inspections for MHRA, Health Canada, EMA, or FDA in the last 2 years

Demonstrated experience for implementing GCP inspection readiness activities and tools in past 2 years

Excellent experience in conducting QA Audits, specifically GCP for each type (Clinical Investigator Audits, Vendor Audits, Internal Process Audits) in last 5 years

Excellent understanding or risk-based approaches to auditing

Demonstrated experience for leading Sponsor Audits independently

Previous experience in trending and analysis methodologies

Understanding of 21 CFR Part 11 regulations and other international guidelines specifically addressing Computer Systems Electronic Record/Electronic Signature (ERES)

Excellent understanding of the Drug Development Process

Proven experience in developing, managing and complying with annual budgets

Ability to speak, read and write English fluently

M.S. in a scientific or allied health filed and 7+ years of relevant GCP, GcLP, GLP, GVP and GPP experience

Or Four-year college curriculum with concentration in nursing, biological, physical, health, pharmacy or other related science and 10+ years of relevant GCP, GLP, GVP experience

And ≥ 8-10 years of strong managerial experience

IT literate, experienced with Microsoft based applications, including proficiency in Excel, Word, Trackwise, SharePoint, and PowerPoint

Domestic and international travel required (approximately 25%)