Quality Specialist, Sponsor Dedicated at IQVIA

Seoul, South Korea, South Korea

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Not SpecifiedCompensation

Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, Clinical ResearchIndustries

Requirements

Bachelor's Degree
A minimum of 1 year of experience in quality assurance or regulatory compliance in the CRO or pharmaceutical industry
At least 5 years of prior experience as a CRA
Preferred experience in internal/external audits and quality management
Strong communication and documentation skills
Excellent problem solving skills
Ability to check compliance with GCP and relevant regulatory requirements
Excellent knowledge of spoken and written English

Responsibilities

Adopt and implement the global Quality Management Plan within the scope of the assignment, including planning and executing Quality Management activities, risk identification and assessment through data review and quality control processes, providing support in risk mitigation, planning corrective/preventive actions, and guidance for improvement
Support the assigned business line management and staff to enhance effectiveness
Cooperate closely with relevant business and other stakeholders to maintain focus on quality in project delivery
Contribute to the development and implementation of a Delivery Unit/Sponsor specific Quality Management Plan and Risk Management Program, and monitor the implementation and delivery
Provide advice and support to teams within the assigned business line and other key stakeholders on all aspects of Good Clinical Practice (GCP) compliance
Work in close cooperation with teams to manage non-compliance and quality issues, and assist in planning corrective/preventive actions according to SOPs
Inform the assigned business line and Quality Assurance of quality issues according to SOPs
Work closely with Quality Assurance and assigned business staff in case of suspected misconduct, as required by applicable SOPs
Provide assistance during audits and regulatory inspections to operational teams, as agreed with Quality Management and required by applicable SOPs
Prepare periodic reports to stakeholders on quality related matters, risk assessments, and specific quality improvement initiatives
Upon agreement with the Line Manager, perform any other reasonable tasks as required by the role

Skills

Key technologies and capabilities for this role

GCPICHSOPsRisk AssessmentRisk ManagementCAPAQuality ManagementKPIsQuality ControlData Review

Questions & Answers

Common questions about this position

What is the salary for this Quality Specialist position?

This information is not specified in the job description.

Is this Quality Specialist role remote or office-based?

This information is not specified in the job description.

What qualifications and experience are required for this role?

A Bachelor's Degree is required, along with a minimum of 1 year of experience in quality assurance or regulatory compliance in the CRO or pharmaceutical industry, and at least 5 years of prior experience as a CRA.

What does the team structure look like for this position?

The role is assigned to designated Delivery Unit(s), sponsor(s), business line(s) and/or specific tasks as defined by the line manager, involving close cooperation with relevant business stakeholders, Quality Assurance, and operational teams.

What makes a strong candidate for this Quality Specialist role?

Strong candidates will have a Bachelor's Degree, at least 1 year in quality assurance or regulatory compliance in CRO/pharma, and 5+ years as a CRA, with preferred experience as noted.

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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