JOB DESCRIPTION:

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 Diabetes Care (ADC)

We’re focused on helping people with diabetes manage their health with life-changing products that provide accurate data to drive better-informed decisions. We’re revolutionizing the way people monitor their glucose levels with our new sensing technology.

MAIN RESPONSIBILITIES:

• Responsible as Quality Management Representative for Japan.
• Manage Marketing Authorization Holder by leading Quality Controller and Safety Controller under legal requirements. Collaborate with Marketing Authorization Holders of other divisions in Abbott in Japan upon necessity.
• Establish and aggressively drive the Quality Assurance strategy for Japan by taking ownership and aligning with key Global ADC Quality strategies and direction.
• Ensure consistent application of relevant Quality Assurance policies, programs, and systems by clearly defining specific Abbott and Abbott Diabetes Care SOPs and locally developed procedures that govern critical to success business functions. Recognition that some degree of flexibility to execute activities appropriate to local requirements and market needs is also required.
• Elevates issues or significant events (product performance issues) to the appropriate facility with relevant facts and details sufficient to allow Subject Matter Experts responsible for the product quality and performance to analyze, investigate and provide feedback and corrective actions appropriate to the issue.
• When quality gaps are identified, Corrective and Preventive Actions (CAPA) are required, formulate detailed action plans that integrate identified stakeholders, the actions necessary and the required methods and timelines to successfully correct the problem and prevent the issue from recurring / occurring. Ensure CAPAs identified during audits or other means are successfully resolved prior to committed due dates.
• Work within Japan to assist affiliates in audit responses and appropriate corrective actions. Review affiliate audits and respond to assure any similar deficiencies are also addressed.
• Establish effective partnerships within the business locations to ensure QA needs are identified and successfully met. Respond to manufacturing site requests (e.g. quality holds, reworks, complaint product returns).
• Organize and develop timely action plans in close coordination with the local/Area Customer Service Manager ensuring a seamless execution of successful QA strategies for Japan.
• Develop and maintain a QA status report covering routine department functions and providing updates on key problem resolution initiatives. Examples may include status of safety alerts, quality holds, field actions (recalls), and CAPAs. The status report will include current projected completion dates and will be updated and published as required / when status changes. Periodic review of Japan documents and procedures.
• Strong knowledge, interpretation and practice of Japan MHLW and PMDA regulations as this position requires the incumbent to build effective relationships with local regulators, agencies, and trade organizations to influence direction of regulations, requirements, and performance expectations.
• Perform local assessments for new partners (e.g. distributors) and help ensure processes are in place at those partners to maintain product and process quality.
• Perform Gap Analysis to help drive consistency between affiliates and manufacturing facilities. Evaluate and interpret industry regulations and division policies and develop strategies for ensuring affiliates are compliant.
• Expected approximate 15% of travels to international locations

BACKGROUND:

• Medical device, Pharmaceutical or related industry experience (10+ years) in a QA Role.
• Global cross-functional working experiences required.
• ISO13485:2015 certification.
• Strong knowledge of ISO13485, ISO9001, 21CFRpart820 and ISO14971
• Experience in distribution warehouse set-up, qualification and audit.
• Experience in process and documentation audit
• Knowledge and experience in product development, commercialization and manufacturing process in IVD medical device preferred.
• Native in Japanese, and ability to communicate fluently/effectively in spoken and written English is a must.
• Ability to develop problem resolution plans that consider both project variables and potential intangible events so that critical to success deadlines are routinely achieved.
• Must possess a high degree of responsibility and deep sense of ownership for ensuring the highest level for QA standards. Position will require the ability to rapidly retrieve existing standard operating procedures (SOPs), deploy them as required to facilitate commercial business operations and in some cases develop procedural solutions to appropriately resolve quality and compliance challenges.
• Pharmacist License preferrable
• Desired skills/experiences include:Familiarity with regulations such as ISO 9000/13485, QSR
• Change management
• Experience in working with matrixed organizations
• Program/project management
• Cross-functional/cross-divisional experiences
• Applicable technical knowledge/experience
• Audit evaluations and CAPA resolution planning
• Ability to develop procedures and policies that clearly define efficient and effective processes needed to ensure compliance and resolve identified problems.
• Experience in leading and participating in cross-functional teams tasked with QA problem resolution
• Experience in training curriculum development
• Experienced user of Microsoft Office software: Word, Excel, and PowerPoint

MINIMUM SKILLS REQUIRED:

• Prevent problems from occurring to the greatest extent possible by anticipating issues and proactively seeking solutions.
• Provide guidance and assistance to affiliates to meet business and compliance needs.
• The guidance, recommendations, feedback, actions and decisions made by the incumbent are critical to assuring compliance with applicable regulatory standards and successfully meeting the business needs and objectives of the division.
• The impact of such guidance, recommendations and decisions can have a direct effect on the company’s ability to distribute existing products.
• The incumbent is also responsible for assuring distribution partners have adequate systems in place to store, distribute and/or take customer calls.
• The incumbent must effectively communicate, prepare and negotiate both internally and externally; failure to do so will have a direct impact on market presence.

KNOWLEDGE/EDUCATION REQUIRED:

Bachelor's degree minimum, Bioengineering, Engineering or Business-related discipline

EXPERIENCE REQUIRED:

• 10–15 years of Quality Assurance experience in the medical device industry with management experience leading QA teams.
• Strong working knowledge of Japan QMS Ordinance (MHLW 169), PMD Act, and relevant JIS standards, ISO 13485, ISO 14971, and global quality systems.
• Proven ability to lead regulatory inspections (PMDA/MHLW) and internal audits.

The base pay for this position is

N/A
In specific locations, the pay range may vary from the range posted.

JOB FAMILY:

Operations Quality

DIVISION:

ADC Diabetes Care:

LOCATION:

Japan > Tokyo : Mita South Tower, Minato-ku

ADDITIONAL LOCATIONS:

WORK SHIFT:

Standard

TRAVEL:

No

MEDICAL SURVEILLANCE:

Not Applicable

SIGNIFICANT WORK ACTIVITIES:

Not Applicable