Quality Specialist at IQVIA

Shanghai, Shanghai, China

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Not SpecifiedCompensation

Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Life Sciences, Healthcare, Clinical ResearchIndustries

Requirements

Knowledge of good clinical practices (GCP) and relevant regulatory requirements
Ability to work with Clinical Research project managers and service providers
Skills in identifying, documenting, investigating, and tracking deviations and major breaches
Experience in CAPA (Corrective and Preventive Actions) implementation and follow-up
Capability to organize and coordinate meetings, provide minutes, and ensure communication/escalation
Support for audit and inspection preparation, including risk assessment, root cause analysis, and CAPA definition
Ability to review training materials and participate in training sessions as SME
Skills in liaising with process owners, trainers, and vendors for quality oversight

Responsibilities

Act as Clinical Study QA representative for assigned clinical studies, ensuring GCP and regulatory compliance with project managers
Proactively identify and resolve non-compliance issues within lines of business
Ensure timely CAPA implementation by following up with owners and scheduling meetings
Participate in project meetings and provide timely assistance on quality-related topics
Participate in Vendor’s Quality Assurance Meetings and ensure quality oversight
Contribute to Service Providers selection and oversee quality activities
Support management of quality issues/deviations in collaboration with Service Providers
Implement quality agreements with Service Providers
Ensure documentation, investigation, and tracking of major deviations and potential Serious Breaches in GCP
Organize and coordinate deviation assessment meetings, provide minutes, and ensure communication/escalation
Support audit activities: provide information for risk assessment, facilitate investigations, root cause analysis, and CAPA
Assist in preparation and conduct of inspections as required
Support training sessions by reviewing materials or participating in presentations
Liaise with process owners and trainers to ensure appropriate training materials for clinical research activities

Skills

Key technologies and capabilities for this role

GCPCAPAQuality AssuranceRegulatory ComplianceDeviation ManagementAuditsInspectionsRoot Cause AnalysisClinical ResearchTraining

Questions & Answers

Common questions about this position

Is this a full-time position?

Yes, this is a full-time role.

What is the work location or remote policy for this role?

This information is not specified in the job description.

What key responsibilities are required for the Quality Specialist role?

Key responsibilities include working with Clinical Research project managers to ensure GCP and regulatory compliance, identifying and resolving non-compliance issues, ensuring CAPA implementation, supporting audits and inspections, and assisting with training.

What is the company culture like at IQVIA?

This information is not specified in the job description.

What makes a strong candidate for this Quality Specialist position?

Strong candidates will have experience in clinical study QA, knowledge of good clinical practices (GCP), skills in CAPA management, deviation tracking, audit support, and collaboration with project managers and service providers.

IQVIA

Advanced analytics and clinical research services

About IQVIA

IQVIA provides advanced analytics, technology solutions, and clinical research services specifically for the life sciences industry. Their services utilize extensive data resources and technology to create connections within healthcare, allowing clients to gain insights that help speed up the development and marketing of new medical treatments. This process is facilitated by their IQVIA Connected Intelligence™ system, which offers quick and flexible insights. IQVIA stands out from competitors by focusing on patient privacy, employing various technologies to protect individual data. The company's goal is to enhance healthcare outcomes by supporting biotech, pharmaceutical, and medical device companies, as well as researchers and government agencies, in understanding diseases and advancing medical science.

Durham, North CarolinaHeadquarters

1998Year Founded

$3,526MTotal Funding

POST_IPO_EQUITYCompany Stage

Cybersecurity, Biotechnology, HealthcareIndustries

10,001+Employees

Risks

Rapid advancement of cancer vaccines may disrupt traditional clinical research models.

Proliferation of disparate technological solutions causes technology overload in clinical trials.

Generative AI technologies face challenges in adoption due to data privacy concerns.

Differentiation

IQVIA leverages advanced analytics and big data for life sciences solutions.

The company offers privacy-enhancing technologies to protect individual patient data.

IQVIA's AI Assistant provides rapid, actionable insights for healthcare and life sciences.

Upsides

Increased adoption of decentralized clinical trials enhances patient-centric study designs.

AI-driven drug discovery accelerates identification of potential drug candidates.

Expansion of telemedicine facilitates remote patient monitoring and data collection.

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