Compliance and Quality Specialist

Kuala Lumpur - Malaysia

Monthly Salary: Not Disclosed

Posted on: 22 hours ago

Vacancies: 1 Vacancy

Job Summary

The Local Compliance Specialist ensures an integrated and comprehensive quality and compliance approach for clinical trials in close collaboration with the sponsors local and global quality functions and ensures clinical trials are performed in compliance with local laws and regulations industry standards and sponsors processes and procedures. Key responsibilities may include execution of various QC checks Quarterly Quality Reviews (QQR) audit and inspection support CAPA support local SOP management new hire onboarding/training SOP/GCP consultation country regulatory intelligence local vendor management and support of Local Operating Company (LOC) Management Reviews.

Key Responsibilities:

Quality and Compliance Oversight:

Monitor compliance risk and ensure mitigation/remediation actions are defined.
Monitor progress and confirm effectiveness of remediation plans e.g. by performing QC checks or special investigations.
Participate in Quarterly Quality Reviews with local GCO management addressing compliance issues and risk signals.
Collaborate with local and central business partners to facilitate inspections and office audits as needed.
Collaborate with local and central business partners in timely CAPA setting and implementation. Provide Quality Event Management (QEM) CAPA Champion support and/or regional lead responsibilities such as training account management etc.
Develop and manage local procedural documents.
Execute Trial Master File (TMF) QC checks and On-Site Compliance Monitoring Visits (OSCMVs).
Support operational projects for GCO Compliance

Local Onboarding and Consultation:

Support onboarding of new hires (degree of support varies by region/country needs).
Manage local workshops to support QMS and compliance awareness Lessons Learned etc.
Provide subject matter expertise and advice regarding SOP system and GCP questions.
Provide guidance and expertise for managing risk at the country level including assessing root causes and developing effective actions to mitigate risk.

Local regulatory intelligence:

Perform impact assessments of new/revised local regulations guidance and standards.
Ensure local intelligence is up to date (e.g. RIACS T-Race IRON) to support central functions.

Collaborate with Business Quality to support LOC Management Review and local supplier assessments as appropriate.

Keeps oneself inspection ready and knowledgeable for current work by complying with relevant training requirements.

Full utilization by timely and accurate time reporting.

Requirements:

BA/BS degree in a health or science related field
3 years of previous Pharmaceutical Industry experience with 2 years of experience within clinical research and development and/or quality assurance.
Knowledge of the overall drug development process.
Experience in quality assurance activities including audits of clinical investigative sites systems and vendors and audits of regulatory submissions is an asset.
Conflict resolution/management and negotiation skills.
Excellent working knowledge of FDA/ICH and country-specific regulations and guidelines related to clinical development.
Experience with regulatory submissions is an asset.
Experience in R&D process requirements to successfully drive Compliance productivity strategy optimization process improvements and efficiencies including development and management of CAPA and facilitation of Root Cause Analysis.
Demonstrated project leadership skills.
Problem solver strategic thinker leader and collaborator.
Highly committed to quality and compliance.
Possess excellent written oral communication interpersonal skills diplomacy and presentation skills and outstanding customer service.

IQVIA is a leading global provider of clinical research services commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at

Required Experience:

Key Responsibilities:

Quality and Compliance Oversight:

Monitor compliance risk and ensure mitigation/remediation actions are defined.
Monitor progress and confirm effectiveness of remediation plans e.g. by performing QC checks or special investigations.
Participate in Quarterly Quality Reviews with local GCO management addressing compliance issues and risk signals.
Collaborate with local and central business partners to facilitate inspections and office audits as needed.
Collaborate with local and central business partners in timely CAPA setting and implementation. Provide Quality Event Management (QEM) CAPA Champion support and/or regional lead responsibilities such as training account management etc.
Develop and manage local procedural documents.
Execute Trial Master File (TMF) QC checks and On-Site Compliance Monitoring Visits (OSCMVs).
Support operational projects for GCO Compliance

Local Onboarding and Consultation:

Support onboarding of new hires (degree of support varies by region/country needs).
Manage local workshops to support QMS and compliance awareness Lessons Learned etc.
Provide subject matter expertise and advice regarding SOP system and GCP questions.
Provide guidance and expertise for managing risk at the country level including assessing root causes and developing effective actions to mitigate risk.

Local regulatory intelligence:

Perform impact assessments of new/revised local regulations guidance and standards.
Ensure local intelligence is up to date (e.g. RIACS T-Race IRON) to support central functions.

Collaborate with Business Quality to support LOC Management Review and local supplier assessments as appropriate.

Keeps oneself inspection ready and knowledgeable for current work by complying with relevant training requirements.

Full utilization by timely and accurate time reporting.

Requirements:

BA/BS degree in a health or science related field
3 years of previous Pharmaceutical Industry experience with 2 years of experience within clinical research and development and/or quality assurance.
Knowledge of the overall drug development process.
Experience in quality assurance activities including audits of clinical investigative sites systems and vendors and audits of regulatory submissions is an asset.
Conflict resolution/management and negotiation skills.
Excellent working knowledge of FDA/ICH and country-specific regulations and guidelines related to clinical development.
Experience with regulatory submissions is an asset.
Experience in R&D process requirements to successfully drive Compliance productivity strategy optimization process improvements and efficiencies including development and management of CAPA and facilitation of Root Cause Analysis.
Demonstrated project leadership skills.
Problem solver strategic thinker leader and collaborator.
Highly committed to quality and compliance.
Possess excellent written oral communication interpersonal skills diplomacy and presentation skills and outstanding customer service.

Required Experience:

Key Skills

Quality Assurance
FDA Regulations
Data Collection
Food Safety Experience
ISO 9001
Mobile Devices
Root cause Analysis
Quality Systems
OSHA
Food Processing
Quality Management
cGMP

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About Company

IQVIA

IQVIA is the Human Data Science Company™. We are inspired by the industry we serve and provide solutions that enable life sciences companies to innovate with confidence, maximize opportunities and ultimately drive human health outcomes forward. Our approach is Human Data Science – a d ... View more

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