Associate QA Director, Pharmacovigilance

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.

Job Overview:

This position will be supporting Pharmacovigilance activities within IQVIA, serving as QA support to PV-related functions and tasks. Oversee & coordinate assigned QA program in support of customer accounts, functional accounts, audit and inspection program, or QA quality management system at a regional and/or global level.  Provide insights, analyses and support in the assessment and promotion of compliance with global clinical and post-marketing GVP regulations, guidelines, and operating procedures, risk identification and mitigation, quality, process, productivity/efficiency improvement initiatives.   Manage the quality assurance oversight of projects, assignments, training, and staff.

Responsibilities:

• Undertake ongoing risk analysis of systems and processes, to propose PV process audits, support quality related investigations, and monitor operational actions to improve existing processes.
• Provide Quality Assurance support, guidance, and management of Quality Issues, as assigned
• Conduct trend analysis of audit and other quality related data, provide to internal/external stakeholders as agreed
• Support regulatory inspections and customer audits as a functional QA subject matter expert
• Provide guidance, interpretation, support, training, and key input to development groups for consultation and interpretation of regulations, guidelines, corporate standards, and policies
• Plan, schedule, conduct, report, and close audit activities, or provide QA subject matter expert support to these activities as assigned
• Participate in or lead (cross functional) teams for special projects as assigned

Required Knowledge, Skills, and abilities:

• Knowledge of word-processing, spreadsheet, and database applications.
• Strong knowledge of pharmaceutical research and development processes and regulatory environments; clinical and post-marketing pharmacovigilance experience is essential.
• Previous experience of GVP regulatory inspections.
• 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.
• Ability to coordinate timelines with internal customers and external vendors on a global scale.
• Ability to work globally and manage multiple activities and timelines.
• Ability to establish and maintain effective working relationships with coworkers, managers and clients.

Required Education and Experience:

• Demonstrated ability to lead and manage multiple responsibilities.
• Bachelor's Degree Required.
• Minimum 10 years of Quality Assurance experience in pharmaceutical, or related area including GVP Quality Assurance experience. Equivalent combination of education, training, and experience.

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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 70,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law.

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.