Associate QA Director

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 QA Director in the Customer Strategy team who will serve as the Stakeholder Engagement Lead (SEL) for one or more IQVIA customers.  The SEL role includes the following activities for the assigned customers:

Responsibilities:

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

• Provides actionable insights from quality and operational data analysis and proactively working with the customer and the account team to develop action plans to drive continuous improvement.

• Analyzes trends in quality issue reporting and timeliness to ensure adherence to quality issue management requirements across project teams

• Supports the management and resolution of significant issues relating to quality;

• In collaboration with Quality Management, ensures projects are inspection ready starting at the design stage.

• Drives inspection readiness activities for the customer, including contributing to mock inspections by/of the customer

• Contributes to the development of the global risk-based internal audit plan.

• Advises customer Quality counterparts on the strategy for regulatory inspections and collaborates in the preparation for and management of inspections at customer offices and, as necessary, at investigator sites.

• Prepares for and actively participates in relevant Governance/partnership level meetings e.g. Quality Councils/ Joint Operations Committee (JOC) or equivalent meetings with customer Quality counterparts.

• Interfaces with senior management to discuss quality and compliance issues

• Interfaces with business development and operations to identify business opportunities

• Hosts and/or supports customer audits and ensures appropriate and sustainable action plans are developed and implemented.

Required Knowledge, Skills and abilities:

• Knowledge of word-processing, spreadsheet, and database applications.
• Thorough understanding of current GCP, GPV, and other relevant current quality compliance requirements of major regulatory agencies (FDA, EMA, PMDA, MHRA, TGA, etc.)

• Strong knowledge of pharmaceutical research and development processes and regulatory environments, with an emphasis on clinical research.

• 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.

• Demonstrated ability to lead and manage multiple responsibilities.

• Identify functional constraints and identify solutions.

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

• 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:

• Bachelor’s degree in a scientific or healthcare-related field
• Demonstrated experience leading and successfully and timely delivering on implementation of cross-functional initiatives and programs with senior executive leadership visibility.
• Demonstrated expertise in implementing a quantitative approach to risk management.
• Possess experience in hosting audits and regulatory inspections, coordinating responses and CAPA in relation to audit reports, and analyzing audit findings.
• Minimum 10 years of experience in industry, with at least 3 years of experience in pharmaceutical, biotech, or other regulated industry with a focus on enterprise risk management activities and clinical research.  

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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.