49 applicants

Company

Original Job Post

IQVIA · 2 days ago

Quality Assurance Manager

Durham, NC

Full-time

Hybrid

Senior Level

$91K/yr - $152K/yr

7+ years exp

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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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Quality AssuranceGCPAuditingWord ProcessingSpreadsheetDatabase ApplicationsPharmaceutical ResearchRegulatory EnvironmentsQA ProcessesRisk AnalysisProject ManagementRelationship BuildingInterpersonal SkillsProblem SolvingNegotiation SkillsTraining CapabilitiesTeam OrientationLeadership Skills

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

Glassdoor

3.9

IQVIA provides analytics, compliance, and management solutions to the life sciences industry.

Founded in 1982

Danbury, Connecticut, USA

10,001+ employees

https://www.iqvia.com

H1B Sponsorship

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Trends of Total Sponsorships

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2020 (197)