Dir, Technology QA

IQVIA


Date: Sep 23, 2022
City: Durham, NC
Contract type: Full time
IQVIA
Summary:

The IQVIA QA team is a dynamic, talented, and experienced global team that owns the global quality management system for the largest human data science company in the world. The QA function is responsible for driving compliance in a highly regulated industry through audits, functional support, issue & CAPA management, regulatory consultancy, management of data analytics and customer relationship interactions. These services ensure our clinical research activities are of the highest quality. We proactively support our business partners and help to drive innovation. Continuous improvement is a core capability, and we value strategic thinking, creativity and operational excellence. We seek highly motivated people who truly want to make a difference in the life sciences industry and are looking for opportunities to impact the business and be part of the solution. At IQVIA, we support our colleagues with a focus on succession planning, career progression and continuous learning.

Purpose:
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.

Summary of Responsibilities:

Collaborates with Quality counterparts at customers and with internal project teams to promote, support and facilitate proactive quality through the identification and management of risks and implementation of quality improvement activities.

Responsible for building out the Tech QA program & team

Establish and maintain strong working relationships with internal and/or external customer team leads and counterparts, as assigned

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.

Required Education and Experience:

Bachelor\'s Degree

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

Required Knowledge, Skills and abilities:

Experience with CAPA and Root Cause Analysis methodologies

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 advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at

We are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities.

As the COVID-19 virus continues to evolve, IQVIA’s ability to operate and provide certain services to customers and partners necessitates IQVIA and its employees meet specific requirements regarding vaccination status.

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