Santen

Pharmaceuticals

Sr.Manager/Manager,DITComplianceandRiskManagement

$11000–16500k ~AI est. Osaka, Osaka, Japan FULL TIME
The Brief

“Sr. Manager / Manager, DIT Compliance and Risk Management at Santen. Skills: DIT Compliance, Risk Management, GxP, CSV. Operate and improve IT compliance governance. Maintain and improve policies, standards, and processes”

Industry & Context.

Pharmaceuticals

What They're Looking For.

Must Have

Bachelor's degree in Information Systems, 12+ years of experience in DIT compliance, 5+ years of people management experience, Experience in risk identification, Experience in risk assessment, Experience in risk response, Experience in risk monitoring, Fluent Japanese, Business-level English

Nice to Have

International management experience

What You'll Do.

Operate and improve IT compliance governance

Maintain and improve policies

Clarify appropriate compliance levels

Align with regulatory requirements

Operate DIT compliance governance framework

Implement improvement measures

Maintain and improve maturity and risk metrics

Visualize compliance metrics

Report to DIT and QA management

Advise on inspection readiness

Support inspection readiness

Operate CSV Center of Excellence

Ensure standardized CSV practices

Establish and operate integrated risk management framework

Oversee risk management activities

Provide advice and support for risk management

Ensure risk identification

Ensure risk assessment

Ensure risk prioritization

Ensure risk monitoring

Ensure risk documentation

Clarify risk prioritization

Support management decision-making

Ensure transparency of risk status

Promote information sharing

Provide guidance on DIT compliance

Provide training on DIT compliance

Improve employee knowledge and literacy

Provide consultation on compliance matters

Offer expert advice on compliance

Operate and improve organizational functions

Develop and improve team capabilities

Lead team activity planning

Lead resource allocation

Lead budget management

Effectively utilize external partners

Manage external vendors

Strengthen collaboration with stakeholders

Improve collaborative relationships

How You'll Work.

Team & Collaboration

DIT department; QA department; Related internal departments; External partners; Global collaboration

Communication Scope

Meetings; Document creation; Document review

Process & Methodology

Continuous improvement

Free ATS check

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