Job Description

Quality Assurance Director



Primary Location: Durham, North Carolina, United States Additonal Locations: Durham, NC Full time R1139400 Date Posted: 01/13/2021

Job description

Essential Functions
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
Drive quality improvements and efficiencies along with risk mitigation based on QA data analyses, operational performance data, knowledge of process management, changing regulations and customer expectations
Provide consultation and support concerning compliance with regulations and 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 and establishment 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 Standard Operating Procedures (SOP's)
Serve as QA representative on Standard Operating Procedures (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 participate in review of corrective action plans and effectiveness checks.
Recommend process and systems for audit, write systems audit plans and oversee the delivery of these audits, review the Corrective and preventive actions (CAPA's) and ensure appropriate follow up
Oversee documentation, reporting, and closure of significant compliance issues
Support QA Management Leadership in proposal reviews and reporting QA metrics and insights
Act as primary back-up for QA Leadership
Conduct trend analysis of audit results and provide QA management with initial root cause analysis
May present trend analysis results and QA metrics and insights to IQVIA upper management
Ensure proper coordination of customer-initiated audits and mock regulatory inspections, and manage regulatory facility inspections
Manage staff in accordance with organizations 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. Approve actions on human resources matters.

Qualifications
Bachelor's Degree Req
12 years Quality Assurance experience in pharmaceutical, technical, or related area, including GCP Quality Assurance experience. 5 years of management experience. Equivalent combination of education, training and experience.
Knowledge of word-processing, spreadsheet, and database applications.
Extensive knowledge of pharmaceutical research and development processes and regulatory environments.
Considerable knowledge of quality assurance processes and procedures.
Strong interpersonal skills.
Excellent problem solving, risk analysis and negotiation skills.
Effective organization, communication, and team orientation skills.
Senior Management experience in Quality Assurance.
Ability to influence and guide others at all levels of management.
Demonstrated ability to lead and manage multiple responsibilities.
Ability to manage costs effectively through appropriate resource allocation.
Ability to articulate and define departmental needs and processes.
Ability to establish and maintain effective working relationships with coworkers, managers and clients.

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 IQVIAs Talent Acquisition team at workday_recruiting@iqvia.com to arrange for such an accommodation.