IQVIA · 20 hours ago
Manager Quality Assurance, Bioanalysis
Indianapolis, IN
Full-time
Onsite
Mid, Senior Level
$75K/yr - $189K/yr
7+ years expIQVIA is a leading global provider of clinical research services, commercial insights, and healthcare intelligence to the life sciences and healthcare industries. They are seeking a Manager, Quality Assurance - Bioanalysis to oversee QA programs, support compliance with regulations, and manage QA staff development.
AnalyticsHealth CareLife Science
Responsibilities
Providing guidance, interpretation, support, training, and key input to development groups for consultation and interpretation of regulations, guidelines, corporate standards, and policies
Overseeing and participating in the documentation, reporting, and closure of compliance issues
Organizing and delivering training to other IQVIA departments concerning the activities of Quality services, results of activities, quality initiatives, GXP, etc
Ensuring the follow-up of major and critical audit findings to ensure that appropriate actions have been taken and have adequately resolved the issues identified
Evaluating policies and procedures for compliance with applicable regulations/guidelines and provide recommendations to management for continuous process improvements
Serving as author of Quality Assurance Standard Operating Procedures (SOPs) as assigned
Advising Quality Assurance management on system audit needs
Ensuring the Quality Assurance database is maintained and up to date to reflect the status of audits being scheduled, auditor assignment, and audit reporting and/or follow-up status
Qualification
Required
Bachelor's Degree Preferred
7 years of Quality Assurance experience in pharmaceutical, technical, or related areas, including GCP Quality Assurance experience
5 years of management experience
Or other equivalent combination of education, training, and experience may be accepted in lieu of degree
An excellent knowledge of current GXP regulations and guidelines, and associated regulatory requirements
Knowledge of word-processing, spreadsheet, and database applications
Extensive knowledge of pharmaceutical research and development processes and regulatory environments
Considerable knowledge of quality assurance processes and procedures
Benefits
Health and welfare and/or other benefits
Company
IQVIA
IQVIA provides analytics, compliance, and management solutions to the life sciences industry.
10001+ employees
H1B Sponsorship
IQVIA has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (167)
2024 (294)
2023 (261)
2022 (229)
2021 (208)
2020 (180)
Funding
Current Stage
Public CompanyTotal Funding
$3.5B2025-06-02Post Ipo Debt· $2B
2023-11-14Post Ipo Debt· $500M
2023-05-18Post Ipo Debt· $1B
Leadership Team
Chris Colapietro
Vice President, Customer Engagement
Jonathan Morris
VP & GM US Healthcare
Recent News
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