Senior Director Quality Management Oversight

Requisition Number: 5004

Position Title: Senior Director, Quality Management Oversight

External Description:

The Senior Director, Quality Management Oversight is responsible for the strategic vision, oversight, planning, execution, reporting and quality management of the Quality Management Oversight Program. This position reports directly to the EVP Global Head of Quality.

RESPONSIBILITIES:

• Champions and adheres to Worldwide’s Quality Management System (QMS)
• Serves as a positive ambassador of the QA organization with internal and external customers
• Participates in the crafting of the QA organizational goals and objectives as assigned
• Plans, adjusts, manages, and optimizes all resources (budgets, staff and technologies) for the advancement of the QA’s goals and objectives for the Quality Management Oversight Program (QMO)
• Leads a team of Quality Professionals to oversee the delivery of quality deliverables, on time, and in compliance with regulations and Worldwide processes
• Defines, monitors, tracks, and reports Key Quality Indications (KQI) and Quality Tolerance Limits (QTL)

for the QMO Program

• Serves as a co-Chairperson of the Quality Issue Governance Committee (QI-GC)
• Ensures compliance to Worldwide’s’ Quality Management System (QMS)
• Serves as the Subject Matter Expert (SME) for Quality Issues (QIs) and Corrective and Preventive Action (CAPA) Management
• Drives process improvements for processes as related to QMO inclusive of QI/CAPA Management and training
• Leads/Participates in the development and review of Quality Management Documents
• Develops QCOP budget annually
• Approves work related travel and expenses reports for direct reports while staying on budget and in compliance with Worldwide Travel Policy
• Conducts employee performance appraisals as per Worldwide processes
• Provides leadership oversight, supervision, mentorship, and coaching to employees
• Performs other duties as assigned.  The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive
  
  OTHER SKILLS AND ABILITIES:

• Demonstrated advanced organizational leadership competences
• Demonstrated ability for driving results and role modeling a cross functional collaborator
• Demonstrated ability to effectively communicate, escalate, and influence the outcomes of decision-making process
• Demonstrated advanced project management and decision-making skills
• Demonstrated advanced ability to effectively communicate and influence the outcomes of decision-making process
• Communicates professionally, concisely, clearly and consistently to external and internal customers both verbally and in writing
• Demonstrated ability to think critically and lead calmly in complex situations, with strong decision-making skillset
• Ability to lead a team of individuals with a clear vision and defined purpose
• Demonstrated skills for influencing, being resourceful, managing conflict and negotiating
• Demonstrates an advanced aptitude for facilitating group or project initiatives and building team unity
• Works with a sense of urgency; ability to recognize time sensitivity and leads assertively
• Has a strong understanding of clinical research principles and processes for clinical trials
• 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 an asset

 REQUIREMENTS:

• Possesses broad expertise related to understanding the principles and application of quality and regulatory compliance related to GxP activities
• Advanced understanding of the principles for a GCP Quality Management System
• Advanced working knowledge of ICH Guidelines, FDA regulations, European Directives, MHRA Statutory Instruments, AIFA CRO Decree
• Advanced understanding of the Drug Development Process
• Recent experience in leading Process Management activities
• Understanding of 21 CFR Part 11 regulations and other international guidelines specifically addressing Computer Systems Electronic Record/Electronic Signature
• 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 and GMP knowledge an asset
• Proven experience in developing, managing and complying with annual budgets
• Ability to speak, read and write English fluently
• Bachelor’s degree in nursing, biological, physical, health, pharmacy or other related science; M.S. in a scientific or allied health filed preferred
• Minimum 12-15 years of relevant GCP, GcLP, GLP, GVP and GPP experience
• Minimum 5 years managerial experience with direct oversight of a team
• Highly proficient with Microsoft based applications, including Excel, Word, Trackwise, SharePoint, and PowerPoint.
• Domestic and international travel required (approximately 30%)

Promotion to the next level is not automatic based on years of experience.

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Employment Type: Regular

Community / Marketing Title: Senior Director Quality Management Oversight

Company Profile:

We’re a global, mid-size CRO that pushes boundaries, innovates and invents — because the path to a cure for the world’s most persist diseases is not paved by those who play it safe, but by those who take pioneering, creative approaches, and implement them with quality and excellence. We are experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs, in the best possible way.

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