Senior Manager for Quality Operations & Compliance

About Abbott

Abbott is a global healthcare leader, creating breakthrough science to improve people's health.
We're always looking towards the future, anticipating changes in medical science and technology.

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life.
You will have access to:

• Career development with an international company where you can grow the career you dream of.
  
• A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
  
• A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.
  

Abbott Rapid Diagnostics Medical

• Abbott Rapid Diagnostics Medical Co., Ltd is part of Abbott's Diagnostics family of businesses, bringing together exceptional teams of experts and industry leading technologies to support diagnostic testing which provides important information for treatment and management of diseases and other conditions.
  
• We supply variety of rapid diagnostics products throughout the world, EU, Asia, Canada and Japan.
  All of the products are designed, manufactured and released by us.
  

The Opportunity

The position of Senior Manager for Quality Operations & Compliance, is within our Abbott Rapid Diagnostics Medical Co., Ltd, located at Matsudo, Chiba (Chiba Plant).
Due to portfolio of our products, Chiba plant is compliant with regulations throughout the world (except US), not just Japanese regulations.

This position provides quality oversight and leadership by proposing and implementing process improvements and maintaining and improving various quality system processes.
Train others and advance the state of each regulatory requirements and compliance knowledge of the organization.

Support projects to be completed within time and in full and in compliance with all relevant regulatory requirements.
Establish plan to meet department goals, compliant with site level policies and procedures, aligned with the quality system and consistent with regulatory requirements and business objectives.

This job function has accountability for complying with the applicable elements of Global Quality and the Quality Management System (QMS).

This job description will be reviewed periodically and is subject to change by management.

What You'll Do

• Work on maintaining and improving the Quality Management System (QMS) to comply with compliance.
  Identify key process indicators, monitor and analyze, and support to report to management.
• Lead Root Cause Investigation, Impact and Risk Assessment for market, CAPA identification and implementation for issues occurred at Chiba site including production and labs.
  Also, act as the process champion for non-conformance and CAPA process.
• Evaluate and monitor the results of external and internal audits.
  Support to report the audit results to management and execution of corrective actions associated with the audit results.
• Work on maintaining and improving the document management system and document change management process, such as building effective document structure, new document issuance, revision and obsoletion, document review, approval, issuance and effective of document in order to comply with applicable standards/requirements.
• Work on maintaining and improving the education and training system to ensure proper product quality and meet applicable standards/requirements.
  This activity includes developing and implementing a continuous training plan to improve awareness of the Quality Management System.
  Assign training programs through the training system as needed and support employees to complete their assigned training programs on time.
• To achieve Quality Goals consistent with each quality system, implement concrete plans with clear milestones and lead the plan.
• Manage performance of quality engineers/specialists towards department and company goals, including feedback on performance, appraisals, coaching, talent management, open communication etc.

Required Qualifications

• Bachelor's degree in areas such as medical, engineering, science and chemistry.
• 10 plus years of experience in the medical device, diagnostic products or pharmaceutical industry.
• Work experience in manufacturing environment such as Quality Assurance, Quality control, Manufacturing, Engineering etc.
• Knowledge, skill and work experience of quality systems specially on CAPA and root cause analysis.
• Skill and work experience establishing quality systems in manufacturing environment, meeting domestic and global requirements, and also managing the same system .
• Knowledge, skills and work experience of improvement process.
• Flexibility to adapt to any changes and ability to effectively prioritize.
• Excellent written and verbal communication skills.
  Japanese and English reading, writing and speaking ability.

PREFERRED QUALIFICATIONS:

• Understanding of ISO 13485, MDSAP, IVDD/IVDR, In-Vitro Diagnostic Drug Manufacturing License, requirements and product development.
• Process Excellence certified (Green Belt / Black Belt).
• Analytical/Problem Solving Skills (e.g.
  DMAIC, statistical techniques, risk analysis).
• Knowledge EU, Asia, Japan regulatory requirements.

COMPETENCIES:

• Language Competencies :
  In addition to Japanese and English, having language proficiency in Korean or Chinese is preferable.
• Drives for Results:
  Leverages resources, tools and technologies in order to progress more effective and efficient.
• Fosters Collaboration:
  Avoids getting stuck in a 'one right way' approach and remains open minded to new ideas.
  Actively develops a network to bring best solutions to the team or customer.
• Provide mentoring in quality, compliance, and technical areas across multiple work groups.

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life.
Abbott is an Equal Opportunity Employer, committed to employee diversity.

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