Associate Director, QA

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:

This position is an Associate Director, Quality Assurance in the Business Reporting & Analytical Insight Network (BRAIN) Data Reporting & Systems (DRS) team who will serve as the lead quality metric reports developer and electronic quality management system (eQMS) Tier 1 support coordinator.  The Associate Director, Data Reporting & Systems role includes the following activities:

Responsibilities:

• Designs, develops, implements and maintains complex metrics reports and charts.  These reports and charts are submitted to all levels of management including the Board of Directors. Performs monthly data refreshes on all QA metrics dashboards.
• Oversees Tier 1 support for the electronic quality management system (eQMS). Responsible for certain aspects of the eQMS, including data changes, running routine data queries, providing account access, and developing and delivering user training and documentation.
• Provides subject-matter expertise related to the eQMS and metrics reporting dashboards.
• Participates in an enterprise-wide eQMS implementation project as the business technical lead. Participates in system validation activities and leads the re-creation of a suite of metrics dashboards on the Spotfire reporting platform.
• Undertakes Project Management activities in relation to the development of new and updates to existing reports required from the eQMS, QA process improvements, and robotic process automation (RPA) of BRAIN team tasks.
• Develops, implements and manages processes / best practices related to the development, validation, support, maintenance of the metrics dashboards.
• Develops and delivers training as needed.
• Manages staff in accordance with organization’s policies and applicable regulations. Responsibilities include planning, assigning, and directing work; appraising performance and guiding professional development; rewarding and disciplining employees; addressing employee relations issues and resolving problems.
• Participates in the selection and on boarding process for new Data Reporting & Systems (DRS) staff by conducting candidate review and participating in the interviewing process. Conducts on boarding training for new staff in conjunction with Human Resources and Learning and Development training programs.
• Ensures that staff has the proper materials, systems access and training to complete job responsibilities. Provides oversight for the execution of the training plan and mentored training experiences, as applicable.
• Ensures that staff are meeting defined workload and performance expectations through regular review and reporting of findings as outlined by Management, identifies quality risks and issues and creates appropriate action plans to prevent or correct deficiencies in performance of staff.

Required Knowledge, Skills and abilities:

• Very strong knowledge of metric dashboard development in a business intelligence (BI) and analytics tool.
• Knowledge of word-processing, spreadsheet, and database applications.

• Strong knowledge of pharmaceutical research and development processes and regulatory environments.
• Strong knowledge of validation of GxP-compliant computer systems.

• Considerable knowledge of electronic quality management systems (eQMS).
• Considerable knowledge of quality assurance processes and procedures.

• Strong interpersonal skills and the ability to positively influence and guide others

• Excellent problem solving, risk analysis and negotiation skills.

• Effective organization, communication, and team orientation and leadership skills.

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

• Demonstrated ability to manage a team of personnel.
• Demonstrated ability to lead and manage multiple responsibilities.

• Identify functional constraints and identify solutions.

• Ability to coordinate timelines with internal customers.

• Ability to manage multiple activities and timelines.

• Ability to articulate and define departmental needs and processes.

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

Required Education and Experience:

Must Have:

• Minimum 5 years of experience developing complex metrics dashboards using business intelligence (BI) and analytics software (Spotfire preferred). SQL experience an advantage.
• Minimum 3 years support of a regulated computer system, including deep knowledge of validation principles.

Nice-to-Have:

• Minimum 2 years of experience implementing, supporting and/or administering an electronic quality management system (eQMS).
• Pharmaceutical, biotech or other regulated industry experience preferred.
• Demonstrated experience leading and successfully and timely delivering on implementation of cross-functional initiatives and programs with senior executive leadership visibility.

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At IQVIA, 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. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 67,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.

IQVIA is an EEO Employer - Minorities/Females/Protected Veterans/Disabled

IQVIA, Inc. provides reasonable accommodations for applicants with disabilities.  Applicants who require reasonable accommodation to submit an application for employment or otherwise participate in the application process should contact IQVIA’s Talent Acquisition team at workday_recruiting@iqvia.com to arrange for such an accommodation.