IQVIA

Senior QA Auditor - GCP Audits

IQVIA • $75K — $188K *
Durham, NC 27713In-Person
Pharmaceuticals & Biotech
5 - 7 years of experience
Reposted 2 days ago
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Job Overview by Ladders

Qualifications

  • Bachelor's Degree preferred
  • 5 years in pharmaceutical or technical field, with 3 years in Quality Assurance Audits
  • GCP experience
  • Conducted clinical trial Investigator site audits
  • Knowledge of pharmaceutical R&D processes and regulatory environments
  • Strong interpersonal and problem-solving skills
  • Ability to manage multiple projects and work independently

Responsibilities

  • Plan, schedule, and conduct GCP audits across multiple countries
  • Evaluate audit findings and prepare reports for stakeholders
  • Provide consultation on compliance status and interpretations
  • Review and approve CAPA plans and track them until closure
  • Maintain an electronic quality management system for audit lifecycle
  • Lead QA initiatives for quality and process improvements
  • Assist in training new Quality Assurance staff

Benefits

  • Opportunities for travel (30-50%)
  • Engagement in projects for quality and compliance
  • Collaborative work environment with cross-functional teams
  • Possibility of presenting educational programs
Full Job Description

Overview:

Plan and conduct independent clinical (GCP) audits to assess compliance with regulations, guidelines, and operating procedures. Prepare and distribute reports of findings to supervisor, operations staff, management, and customers. Provide consultation in interpretation of regulations, guidelines, policies, and procedures. Support management in promotion and assessment of compliance to regulations, guidelines and corporate policies.


Essential Functions:

  • Plan, schedule, conduct, report and close audit activities in any of the countries involved with IQVIA contracts to assess compliance with applicable regulations/guidelines, customer requirements, IQVIA SOPs and project specific guidelines/instructions
  • Evaluate audit findings and prepare and distribute reports to operations staff, management, and customers
  • Provide interpretation and consultation to project teams on regulations, guidelines, compliance status, and policies and procedures
  • Provide consultation to customers and monitors in interpretation of audit observations and formulation of corrective action plans
  • Review, approve investigations, Root Cause Analysis (RCA), Corrective Action Prevention (CAPA) and Effectiveness Check (EC) plans and track till closure for quality events arising from Audits; and from Quality Issues, Inspections or during similar QA activities as assigned.
  • Evaluate policies and procedures for compliance with applicable regulations/guidelines and provide recommendations to management for continuous process improvements
  • Maintains the electronic quality management system (eQMS) and provides support in relation to the audit lifecycle
  • Lead/collaborate/support in QA initiatives/projects for quality, process improvements
  • Assist in training of new Quality Assurance staff
  • May be required to manage Quality Issues
  • May present educational programs and provide guidance to operational staff on compliance procedures
  • May perform pre-inspection visits at sites, host audits/inspections; ensure proper conduct of customer-initiated audits and mock regulatory inspections, and assist in regulatory facility inspections, as assigned.


Qualifications:

  • Bachelor's Degree Pref
  • Travel 30-50%
  • 5 years experience in pharmaceutical, technical, or related area, of which 3 years in Quality
  • Assurance Audits. GCP experience. Equivalent combination of education, training and experience.
  • Experienced in the conduct of clinical trial Investigator site audits.
  • Experience in the conduct of clinical study report/data management/biostatistics clinical trial audits is preferred.
  • Knowledge of word-processing, spreadsheet, and database applications.
  • Extensive knowledge of pharmaceutical research and development processes and regulatory environments.
  • Knowledge of quality assurance processes and procedures.
  • Strong interpersonal skills.
  • Excellent problem solving, risk analysis and negotiation skills.
  • Strong training capabilities.
  • Effective organization, communication, and team orientation skills.
  • Ability to initiate assigned tasks and to work independently.
  • Ability to manage multiple projects.
  • Ability to establish and maintain effective working relationships with coworkers, managers and clients.

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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