Job Description

16673-QA Mgr



Primary Location: Durham, North Carolina, United States Full time R1180776 Date Posted: 02/16/2021

Job description

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:

A QA Manager is responsible for providing support to management in the promotion and assessment of compliance with regulations, guidelines, and operating procedures. Manage QA oversight of projects, assignments, and training. Provide consultation in interpretation of regulations, guidelines, policies, and procedures. Prepare and distribute reports of findings to operations staff, management, and customers. Provide consultation in interpretation of regulations, guidelines, policies, and procedures.

Summary of Responsibilities:

* Provide interpretation and consultation to project teams on regulations, guidelines, compliance status, and policies and procedures.
* Provide consultation to customers, functional leads and monitors interpretation of audit observations and formulation of corrective action plans.
* Prepare, review and approve corrective action plans
* Present educational programs and provide guidance to operational staff on compliance procedures.
* Conduct quality assurance consultancy activities and projects for clients within budget and established timelines.
* Organize and deliver training to other IQVIA departments concerning the activities of Quality services, results of activities, quality initiatives, GXP etc.
* Ensure the follow-up of major and critical audit findings to ensure that appropriate actions have been taken and have adequately resolved the issues identified.
* Evaluate policies and procedures for compliance with applicable regulations/guidelines and provide recommendations to management for continuous process improvements.
* Provide training for new Quality Assurance staff.
* Serve as author of Quality Assurance SOPs as assigned.
* Advise Quality Assurance management on system audit needs.
* Oversee documentation, reporting, and closure of compliance issues

Required Knowledge, Skills and abilities:

* Thorough understanding of GCP, PV, and other relevant quality compliance requirements of major regulatory agencies (FDA, EMA, PMDA) and demonstrated experience interpreting and applying relevant regulations, laws and guidance.
* Practical experience applying proactive quality approaches for clinical trials.
* Working knowledge of Trial Master File and/or Real World Evidence and Non-interventional studies preferred.
* 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, team orientation, and leadership skills.
Ability to work independently with initiative.
* Ability to manage multiple projects.
* Ability to establish and maintain effective working relationships with coworkers, managers and clients.

Required Education and Experience:

* Bachelors degree in a scientific or healthcare-related field
* Minimum 5 years of experience in experience in clinical quality in a pharmaceutical, biotech, or other regulated industry.

LI-Remote

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.