Gdp Quality

**_ OBJECTIVES/PURPOSE _**
- Act as primary point of contact for the Quality Enterprise Systems used within TEC including but not limited to the DMS and LMS systems
- to develop and maintain robust effective training content.
- Monitor TEC quality compliance & governance performance
- This role performs the operational quality oversight of and provides guidance to Regional Distribution Centers (RDCs) in Asia/Japan, the responsibilities cover quality aspects of warehousing, distribution and transportation as well as the management of quality and compliance issues of RDCs

**_ ACCOUNTABILITIES_**

Ensure compliance with:

- Write, review and approve new or revised procedures, coordinate the gap assessment process for the TEC team
- Build and manage the Training Curriculum requirements for the team, supported by management
- Monitor key performance indicators, evaluates and highlights any significant trends and identifies actions prepare metrics for the Management Review of Quality Systems.
- Coordination and execution of local Quality Council / Management Review.
- Maintain the local quality risk register. Engage TEC stakeholders to proactively identify quality risk areas, and establish appropriate risk mitigations and risk monitoring program
- Supports internal and external audits and regulatory inspections as needed, and maintains supportive documentation for the QMS Documentation
- Participate in continuous improvement (Agile) initiatives and quality culture activities
- Maintain expertise in quality systems and quality processes
- Execute daily activities associated with implementation and maintainance of the QMS supporting activities of the trading entity team.
- Support operational quality oversight of and provides guidance to Regional Distribution Centers (RDCs)/ Global Distribution Centres (GDCs) as required.
- Evaluate the level of GMP/GDP compliance and risks for products managed by RDCs in the region through key performance indicators/quality performance indicators and drives the implementation of improvement activities
- Maintain strong collaboration with Supply Chain, Site Quality Organization, RDC related LOC Quality and Takeda project teams

**_ DIMENSIONS AND ASPECTS _**

**Technical/Functional**
- Experience in leading learning projects and/or programs for a large and diverse audience
- Knowledge and experience working in a regulated environment

**Leadership**
- Ability to lead effectively through directing change as well as driving change by influence
- Ability to lead and engage across the globe, with both internal and external stakeholders
- Ability to lead and implement communication, training, performance support strategies and tactics
- Strong attention to details, ability to review & managing documentation

**Decision-making and Autonomy**
- Ability to make decisions on GxP/pharmaceutical activities

**Interaction**
- Key interactions with global and regional stakeholders including Supply Chain, Legal, Tax, BU’s, Quality. Strong partnerships and collaborations to ensure clear definition of requirements and com-pliance to the respective trading licenses.
- Key interactions with numerous stakeholders in Quality (TE RP, OpU quality, Plant and Regional Quality, External Supply Quality)

**Innovation**
- A strong understanding of industry and business, applicable legislation and regulatory compliance requirements.

**Complexity**
- Multiple countries and business units, complex mix of supply & distribution models, multiple regulatory frameworks and a wide diversity of products

**_ EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:_**

**Critical Skills and Competencies**
- Scientific Degree (BSc, MSc)
- 8+ years of pharmaceutical industry experience, Experience must include managing Quality Systems in a pharmaceutical or bio-technical field including DMS/LMS, QMS documentation and training, regulatory intelligence, combined with a good knowledge of regulations pertaining to pharmaceutical manufacturing and distribution in the region (e.g. familiar with cGMP/GDP, ISO and ICH requirements)
- Prior experience managing external GMP/GDP suppliers
- Ability to demonstrate Operational Excellence/Digital and Project Management capabilities
- Solid knowledge of Pharmaceutical manufacturing, quality, manufacturing operations, cGMPs, global regulatory or product development required
- Excellent written and verbal communication skills and fluent in written and spoken English
- Ability to think and act strategically and creatively
- Ability to work successfully in multi-functional and multi-cultural teams
- Demonstrate unquestionable integrity and professionalism
- Customer and patient orientes mindset
- Commitment to Takeda’s values and standards

**Locations**:
Singapore, Singapore

**Worker Type**:
Employee

**Worker Sub-Type**:
Regular

**Time Type**:
Full time