IQVIA

Sr. Clinical QA Auditor

IQVIA • $75K — $188K *
Washington, DC 20011In-Person
Pharmaceuticals & Biotech
5 - 7 years of experience
Reposted 1 week ago
Job Overview by Ladders

Qualifications

  • Bachelor's degree required.
  • 5-10 years in clinical quality assurance, auditing, or operations within CRO, pharma, or biotech environment.
  • Experience in medical devices essential.
  • Expertise in global GCP regulations necessary.
  • Strong verbal and written communication skills critical.
  • Familiarity with ISO standards and EU GDPR regulations preferred.
  • Proficient with MS Office applications, especially Outlook and Teams.

Responsibilities

  • Lead and execute GCP audits for sites, vendors, and internal systems.
  • Plan and report onsite and remote audits aligned with FDA, EMA, and ICH-GCP.
  • Design and conduct mock FDA/EMA inspections to prepare sponsors and sites.
  • Provide onsite audit support during regulatory inspections and coordinate documentation.
  • Support and advise on GCP regulations and quality improvement initiatives.
  • Perform and oversee TMF quality reviews ensuring inspection readiness.
  • Identify compliance risks and evaluate trends for corrective actions.

Benefits

  • Opportunity to work in a fast-paced and innovative MedTech environment.
  • Role allows substantial input in audit and inspection strategy.
  • Exposure to a diverse range of quality systems and regulatory expectations.
  • Continuous improvement culture with emphasis on process enhancement.
  • Chance to influence quality across a variety of clinical trials.
Full Job Description
Overview

The Sr. Clinical QA Auditor is a critical CQA team member. We are seeking an experienced Senior Clinical QA Auditor to support and lead quality assurance activities across clinical trials within a fast-paced CRO environment. This individual will serve as a subject matter expert in GCP compliance, driving audit strategy, inspection readiness, and continuous quality improvement across sponsors, sites, and internal processes.

Responsibilities and Duties
  • Lead and execute GCP audits including investigator sites, vendors, internal systems, and sponsor audits
  • Plan, conduct, and report onsite and remote audits, ensuring alignment with regulatory requirements (FDA, EMA, ICH-GCP)
  • Design and lead mock FDA/EMA inspections and inspection readiness initiatives for sponsors and clinical sites
  • Provide onsite audit support during regulatory inspections, including hosting, documentation, and response coordination
  • Provide support and guidance on GCP regulations and quality improvement initiatives.
  • Perform and oversee TMF quality reviews and audits, ensuring completeness, accuracy, and inspection readiness
  • Identify compliance risks, trends, and gaps
  • Act as a trusted advisor to sponsors, providing strategic input on quality systems and regulatory expectations
  • Contribute to the development and continuous improvement of QA processes, SOPs, and audit methodologies
  • Participate in review of internal and external Quality Issues (QIs) and Corrective and Preventive Action (CAPA) plans.


Required Knowledge, Skills, and Experience
  • Education: Bachelor's degree
  • Experience 5-10 years of experience in clinical quality assurance, auditing, or clinical operations within a CRO, pharma, or biotech environment.
  • Medical device experience required
  • Experience or exposure to global GCP regulations required
  • Excellent oral and written communication skills and presentation skills
  • Familiarity with ISO standards and EU GDPR regulations preferred.
  • Familiarity with the Quality Management System including (but not limited to): quality training, data management, computer system validation, document control, change control, audits and inspections, quality issues and CAPA, vendor management, regulatory compliance, and all areas of GCP.
  • Proficient in all MS Office applications, including Outlook and Teams.
  • Experience in process improvement and project management preferred.
  • Strong working knowledge of eQMS, EDC, eTMF, Document Management and SaaS systems preferred.
  • Demonstrated professional oral and written communications.
  • Ability to read, write, speak, and understand English fluently is required.


Travel Required: 30-40%

The potential base pay range for this role, when annualized, is $75,400.00 - $188,600.00. 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.

About IQVIA

Innovex offers superior and creative advice to corporations. In addition, they raised venture capital for our own affiliate companies, in addition to having assisted clients in fund-raising efforts, new venture outreaches, and financing. Their engineers and technical staff offer varied backgrounds in manufacturing, high tech, product design, quality control, safety, biomechanics, and robotics.

IQVIA Careers

Join the vibrant team at IQVIA, a leading global provider of advanced analytics, technology solutions, and clinical research services to the healthcare industry. IQVIA is recognized for its commitment to innovation, leadership in healthcare, and a culture that celebrates diversity and inclusion.

Work You’ll Do

At IQVIA, we offer job opportunities that empower you to leverage your skills and drive healthcare forward. Become part of a team that thrives on innovation and the pursuit of operational excellence, helping to improve patient outcomes across the globe.

Transform Your Career

IQVIA is the place where you can transform the world of healthcare while advancing your career. With a variety of positions available, from research and development to business analytics, IQVIA is at the forefront of the industry. Our leadership is committed to fostering a culture of growth and professional development, making IQVIA a prime environment for both seasoned professionals and those seeking an internship to kickstart their career.

Innovative Work Environment

Join over 50,000 dedicated professionals in a dynamic environment where technology meets healthcare. At IQVIA, innovation isn’t just a buzzword; it's the backbone of how we solve complex challenges. With cutting-edge resources and a collaborative global team, your work at IQVIA directly contributes to advancements in life sciences.

Career Development and Benefits

IQVIA believes in nurturing its team members not just as employees but as individuals seeking to grow their careers. We support this with unmatched benefits, diversity training, and opportunities for leadership development. Our commitment to your career growth is matched by our dedication to providing a supportive and inclusive workplace.

Explore Job Opportunities

Whether you’re looking for a full-time position, part-time work, or a graduate internship, IQVIA offers a range of employment options to match your career ambitions. Our hiring process is designed to be transparent and engaging, helping you to understand where your skills can best be utilized within the company.

Networking and Professional Development

At IQVIA, networking and professional development are part of our DNA. Engage with industry leaders, participate in global conferences, and take advantage of our in-house training programs designed to enhance your skills and advance your career.

Stay Connected

Join Our Team Search open positions that match your skills and interests. We look for passionate, curious, creative, and solution-driven team players. Explore the diverse job opportunities at IQVIA and find where you can make an impact.

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Personalize your subscription to receive job alerts, latest news, and insider tips tailored to your preferences. Discover the exciting and rewarding career opportunities that await at IQVIA. Embark on a journey of growth, innovation, and leadership at IQVIA. Shape your future in an environment that values diversity and fosters professional development. Join IQVIA today and transform healthcare through the power of information and technology.
Learn more about IQVIA
Size
82,000 employees
Market Cap
$37.5 billion
Industry
Pharmaceuticals & Biotech
Net Income
$279 million
Founded
2016
5 Year Trend
+15.3%
Revenue
$11.3 billion
NASDAQ
IQV
* Ladders Estimates

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