Compliance and Quality Specialist

Petaling Jaya, Malaysia | Full time | Hybrid | R1512933

The Local Compliance Specialist ensures an integrated and comprehensive quality and compliance approach for clinical trials in close collaboration with the sponsor's local and global quality functions, and ensures clinical trials are performed in compliance with local laws and regulations, industry standards and sponsor's 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 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.