IQVIA · 4 days ago
Quality Assurance Manager
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AnalyticsHealth Care
Insider Connection @IQVIA
Responsibilities
Host customer audits, mock regulatory inspections, and regulatory facility inspections as needed
Provide guidance, interpretation, support, training, and key input to development groups for consultation and interpretation of regulations, guidelines, corporate standards, and policies.
Oversee and participate in the documentation, reporting, and closure of compliance issues.
Organize and deliver training to other IQVIA departments concerning the activities of Quality services, results of activities, quality initiatives, GXP etc.
Ensure the follow-up of major and critical audit findings to ensure that appropriate actions have been taken and have adequately resolved the issues identified.
Evaluate policies and procedures for compliance with applicable regulations/guidelines and provide recommendations to management for continuous process improvements.
Serve as author of Quality Assurance Standard Operating Procedures ( SOPs) as assigned.
Advise Quality Assurance management on system audit needs.
Ensure 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
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Required
Bachelor's Degree Preferred
7 years Quality Assurance experience in pharmaceutical, technical, or related area. Equivalent combination of education, training and experience.
Experience in GCP Quality Assurance.
Experience hosting audits onsite and remotely.
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.
Strong interpersonal skills.
Excellent problem solving, risk analysis and negotiation skills.
Exceptional training capabilities.
Effective organization, communication, team orientation, and leadership skills.
Ability to work independently with initiative.
Ability to manage multiple projects.
Ability to establish and maintain effective working relationships with coworkers, managers and clients.
Benefits
Health and welfare benefits
Possibility of incentive plans, bonuses, and other forms of compensation
Company
IQVIA
IQVIA provides analytics, compliance, and management solutions to the life sciences industry.
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
Trends of Total Sponsorships
2023 (218)
2022 (199)
2021 (286)
2020 (197)
Funding
Current Stage
Public CompanyTotal Funding
$1.5B2023-11-14Post Ipo Debt· $500M
2023-05-18Post Ipo Debt· $1B
2019-08-08Post Ipo Equity· Undisclosed
Leadership Team
Recent News
The Pharma Letter
2024-05-29
2024-05-05
2024-05-05
Company data provided by crunchbase