Director -Quality応募 後で応募 求人ID R0009809 掲載日 07/24/2019 Location:Singapore, Singapore
ACCOUNTABILITIES (Describe the primary duties and responsibilities of the job. Include only the essential functions of the job. Approximately 5 – 10 bulleted task statements should be identified).
- Quality Management System (QMS)- feedback / implementation of Standards / Procedures / etc.
- Quality Risk Management –(governance / program oversight)
- Metric and Performance Reporting
- Quality Management Reviews / Councils
- Product Quality Reports – (APQR)
- Inspection Readiness Governance
- Quality Compliance Governance (Continuous Improvements / Changing regulations)
- GxP Learning and Training Governance
- Digitization System Implementation Governance
- Data Integrity Governance
- Change Control processes( artwork/labeling as needed)
- External Awareness – changing regulations/competitive intelligence
- Self Assessment / inspection processes
DIMENSIONS AND ASPECTS
Technical/Functional (Line) Expertise(Breadth and depth of knowledge, application and complexity of technical knowledge)
- Knowledge and experience of Bio-Pharmaceutical Research, Development, and Manufacturing
- Deep knowledge and understanding of relevant regulations (FDA, EMA,SFDA,etc.) enabling effective partnerships across the network
- Knowledge and understanding of global and local Quality and Regulatory concepts and requirements (e.g. ICH, EUGMP, Annex 1, Compendia, etc.)
- Knowledge and understanding of relevant technologies and digital solutions desired
- Knowledge and understanding of Local Operating Companies (LOC’s,)
Leadership(Vision, strategy and business alignment, people management, communication, influencing others, managing change)
- Effective communicator
- Ability to lead effectively through directing change as well as driving change by influence
- Ability to lead and engage in complex investigations and propose sound, scientific, and compliant resolutions
- Ability to act locally as well as engaging to support global activities
Decision-making and Autonomy(The capacity and authority to make organizational decisions, autonomy in decision-making, complexity of decisions, impact of decisions, problem-soliving)
- An active member of Operating Unit / Regional Quality Leadership teams.
- Responsible for decision making that balances progress on global initiatives with local/R&D priorities
- Responsible for Region / Op. Unit Quality governance (Quality Councils / Management reviews)
- Responsible for active and timely Incident notifications and associated escalation activities
Interaction(The span and nature of one’s engagement with others when performing one’s job, internal and external relationships)
- Key interactions with all Region / Op Unit / R&D /Quality Head and with Manufacturing and Quality regional and operating unit teams
- Key interface with Global and Site based Quality units (as needed)
- Responsible for supporting sites and Regional / Op. Unit / Quality leads with BOH inspection responses and timely completion of related commitments and CAPA
Innovation(The required level of scientific knowledge, knowledge sharing, innovation and risk taking)
- A firm grasp of industry, scientific and regulatory trends, understanding market conditions and leverages innovation to evolve Takeda to become a model for industry
- Drives innovative electronic solutions in alignment with strategic priorities
Complexity(Products managed, mix of businesses, internal and/or external business environment, cultural considerations)
- This role reports globally but engages locally( Region / OP Unit / R&D, etc) to drive significant progress and sustainable performance of the One QMS in support of both global and local prodcuts.
- The output of this role needs to be appropriately applied to all stages of the product lifecycle.
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:(List the essential and desirable education and competency requirements to perform the primary responsibilities of the job. Any minimum requirements should be noted.)
- Scientific or engineering graduate (BSc, MSc, PhD), preferably complemented by economic education ( MBA) and IT education
- Steadily increasing managerial experience and responsibility > 12+ years combined with strong technical operations background.
- Experience must include successful examples of managing global change by influence – without direct resource control;
- Experience in global pharmaceutical operations, supply chain management, Quality, project management and global environment
- Strong focus on delivering global results as well as building site capability to demonstrate effective governance
- Extensive global pharmaceutical industry knowledge
- Fluent in written and spoken English.