QA Director

Job Overview

Direct, oversee and coordinate assigned quality assurance programs in support of customer accounts, functional accounts, audit and inspection programs or the QA quality management system. Provide insights, analyses and support in the assessment and promotion of compliance with regulations, guidelines, and operating procedures, risk identification and mitigation and quality improvement initiatives.

Essential Functions

• Develop and Drive Artificial Intelligence Solutions in Quality Risk Management (QRM) to automate analytical hierarchy processes to enable faster accurate decisions in increasing complex situations
• Operationalize Process Risk Analytics
• Insights and Recommendations
• Key contributor/stakeholder in Decision Making
  • Eagle Eye Value Proposition regarding making Investments to:
• Resolve Problems
• Mitigate Risks
• Capture Opportunities
  • Workload Assessment Mapping Tool for standard Stakeholder Engagement Lead activities and quality agreement deliverables for value drivers and risk mitigation
  • Quality Governance Intelligence Report Framework / State of the Union
  • Develop and Implement Decision Inventory Framework for the Audit Program
  • Develop and Implement Decision Inventory Framework for the QMS Integration of Mergers and Acquisitions
  • Provide actionable insights to customer counterparts, QA Leadership and Senior Management to drive quality improvements and efficiencies, and risk mitigation based on QA data analyses coupled with operational performance data and knowledge of process management, changing regulations and customer expectations.
  • Provide consultation and support concerning compliance with regulations appropriate controls, quality measures and risk assessment and mitigation in the development of improved or new service offerings across the business.
  • Lead and project manage internal QA quality improvement initiatives
  • Plan, schedule, conduct, report and close audit activities.

•  Assist in enhancement of quality assurance and control policy, and risk identification and mitigation by providing consultation and recommendations to regional and Global QA Leadership.

•  Serve as author for QA SOPs. Serve as QA representative on SOP Taskforce(s) for other IQVIA functional areas as assigned.

•  Participate in or lead teams for special projects as assigned. Teams may be cross functional.

•  Provide guidance, interpretation, support, training, and key input to development groups for consultation and interpretation of regulations, guidelines, corporate standards, and policies.

•   Host customer audits and/or regulatory inspections and participate in review of corrective action plans and effectiveness checks.

•   Recommend process and systems for audit, review process and systems audit plans and oversee the delivery of these audits, review the CAPAs and ensure appropriate follow up.

•  Oversee documentation, reporting, and closure of significant compliance issues.

•  Support QA Leadership in proposal reviews and reporting QA metrics and insights. Act as primary back-up for QA Leadership.

•  Present trend analysis results and QA metrics and insights to senior management.

•  Ensure proper coordination of customer-initiated audits and mock regulatory inspections and manage regulatory facility inspections.

Qualifications:

• Bachelor's Degree Preferred.

• 12 years’ experience Quality Assurance experience in pharmaceutical, technical, or related area including GXP Quality Assurance experience. Equivalent combination of education, training and experience.

• Extensive knowledge of the pharmaceutical research and development process, clinical research and the regulatory environment.

• Possess excellent knowledge of GxP regulations and other applicable regulations.

• Considerable knowledge of quality assurance processes and procedures.

• Knowledge of word-processing, spreadsheet, and database applications.

• Excellent interpersonal, problem solving, risk analysis and negotiation skills.

• Effective organization, communication, and team orientation skills.

• Ability to influence and guide others at all levels of management.

• Possess applicable experience in conducting audits, writing audit reports and analyzing audits.

• Demonstrated ability to lead and manage multiple responsibilities.

• Ability to work independently as well as in a team environment.

• Ability to coordinate timelines with internal customers and external vendors.

• Ability to articulate and define departmental needs and processes.

• Ability to establish and maintain effective working relationships with coworkers, managers and clients.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com

IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. https://jobs.iqvia.com/eoe

The potential base pay range for this role, when annualized, is $127,700.00 - $237,100.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.