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Quality & Compliance Team Lead – Remote

  1. New Jersey
Posting date: 05/30/2024
  1. Full Time
  2. Quality Assurance
R1426193

Job Description

Those who choose to work with us are joining a recognized global leader — a company uniquely positioned to help clients make the most of market opportunities and respond to challenges that affect global healthcare. We’re committed to blending industry expertise and advanced technology to deliver the most accurate perspectives and in-depth analytics on healthcare dynamics.

To join IQVIA means you’ll be part of a worldwide organization where one person can make a difference, and where collaboration and innovation rule. Our people are creative, and client focused. They are among the best and brightest in the industry and bring a broad range of expertise to the table. Our people are analysts, statisticians, software engineers, consultants, sales leaders, marketing, and product managers, and more. The key to our success is our people, whose experience, talent, commitment, and diversity set the standard for the health information industry.

Role Purpose

  • We are seeking a highly motivated and experienced Quality and Compliance Team Lead to join our dynamic team. The successful candidate will be entrusted with a wide range of responsibilities to ensure that our organization adheres to the highest standards of quality and compliance. This role requires a strong leader with a deep understanding of commercial patient services, pharmacovigilance, quality assurance, and regulatory compliance.
  • As a Quality and Compliance Team Lead, you will serve as a liaison to key clients, where your leadership and expertise will contribute to the continuous improvement of our drug safety processes, regulatory and contract compliance, and overall patient safety. This role will require reporting and client facing interaction.
  • You must thrive in a team environment and possess the ability to coach and mentor individuals as needed.

Principal Accountabilities

Your duties will encompass the following key areas:

  • The Quality and Compliance team lead will serve as the key quality and compliance leader for their respective client(s) and is expected to develop a good understanding of Patient Support Services operational processes and business objectives.
  • Provide drug safety and pharmacovigilance leadership to the quality and compliance team, fostering a culture of collaboration, excellence, and continuous learning.
  • Oversee the daily collection, evaluation, and processing of safety data in accordance with regulatory and client requirements ensuring implementation and maintenance of quality control measures. Promptly address any discrepancies and respond to client inquiries.
  • Maintain working knowledge of industry standards and client regulatory requirements, including changes, and ensure IQVIA’s continued compliance with pharmacovigilance regulations and guidelines.
  • Lead the proactive identification of potential safety signals and collaborate with cross-functional teams to develop risk minimization strategies.
  • Responsible for the preparation of weekly, monthly, and quarterly reconciliation reports for all required programs per client contractual obligations as well comprehensive monthly and quarterly quality and compliance reports specific to client business requirements.
  • Communicate upcoming training requirements to ensure all team members receive appropriate training in support of achieving client KPIs and compliance to contract and regulatory requirements. Support training delivery as needed.
  • Continuously identify areas of improvement in quality and compliance workflows and optimize internal processes to enhance IQVIA’s service offerings.
  • Serve as quality and compliance subject matter expert in support of client audits/inspections, ensuring the proper conduct of customer-initiated audits and providing invaluable support during regulatory inspections. Rigorously evaluate audit findings, collaborate closely with relevant stakeholders to provide insights into audit observations and assist in the formulation of corrective action plans. Ensure timely follow-up on major and critical audit findings, ensuring that necessary actions have been taken to effectively resolve identified issues.
  • Where applicable, contribute as an author of Quality Assurance Standard Operating Procedures (SOPs) as assigned, reflecting your deep expertise in the field.
  • Assist in maintaining IQVIA’s electronic quality management system (eQMS), ensuring its accuracy, and providing crucial support throughout the audit lifecycle.
  • As a Quality and Compliance Team Lead, you will collaborate with talented professionals across departments to promote a culture of quality excellence throughout the organization.

Minimum Required Education & Experience:

  • Associates/Bachelor’s degree in pharmacy, life sciences, or a related field; advanced degree preferred.
  • 3-5 years of experience in drug safety, pharmacovigilance, quality assurance, or a related field.

Skill and Abilities:

  • Excellent communication, interpersonal, and negotiation skills.
  • Analytical mindset with the ability to identify and solve complex problems.
  • Detail-oriented with a commitment to maintaining high standards of quality.
  • Ability to make informed decisions under pressure and in complex situations.
  • Ability to initiate assigned tasks and work independently with minimal oversight.
  • Proven leadership experience, including the ability to work collaboratively in a cross-functional environment.
  • Proven ability to manage multiple projects and maintain effective working relationships with coworkers, managers, and clients.
  • Proficient in organized data collection with experience in using quality management tools.
  • Knowledge of Microsoft Office applications; word, excel spreadsheets, PowerPoint Etc.
  • Experience in pharmacovigilance databases and adverse event reporting systems is a plus.
  • Experience in quality assurance, preferably in life sciences or pharmaceutical industry is a plus.

This position holds a central role in our commitment to quality and compliance, and your dedication and expertise will be instrumental in ensuring our ongoing success. As a self-starter with a keen eye for detail and a commitment to excellence, you will thrive in this dynamic and critical role. Your ability to communicate and collaborate effectively, coupled with your strong analytical and problem-solving skills, will enable you to make a significant impact on our organization's quality and compliance efforts.

IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. 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. Learn more at https://jobs.iqvia.com

We are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities. https://jobs.iqvia.com/eoe

IQVIA’s ability to operate and provide certain services to customers and partners necessitates IQVIA and its employees meet specific requirements regarding COVID-19 vaccination status. https://jobs.iqvia.com/covid-19-vaccine-status

The potential base pay range for this role is $55,000-$60,000 annually. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.

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