MAIN PURPOSE OF ROLE

To oversees the effective implementation and maintenance of Quality System within Abbott Japan and ensuring awareness and continual improvement across the local organization.

MAIN RESPONSIBILITIES

• Ensure compliance of commercial site to local and relevant Division quality and regulatory requirements specifically Japan GQP requirements for drug products.

• Monitor and ensure release for sale of all products which conform to Abbott and local regulatory requirements and specifications.

• Develop and maintain Quality Agreements and records for all Third Party Manufacturer (TPM) sites. Approve or reject products over-labeled by TPMs by reviewing and auditing of batch relevant documentations.

• Manage and support raw material suppliers used by TPM together with respective Division/TPM functions. Ensure suppliers are acceptable to both Abbott and regulatory requirements including Japan GQP.

• Management of product complaint processes. Liaise with business and manufacturing plants for complaint investigation and relevant CAPA implementation.

• Coordinate and implement product field actions (recalls, safety alerts etc.).

• Ensure Quality Systems are in place that meet the requirements for business needs, local regulatory authorities and Abbott Quality Assurance.

• Provide guidance and advice, as requested, on the development and implementation of quality systems in the relevant departments in Abbott Japan.

• Develop, review, release, and maintain Quality System related SOPs.

• Coordinating, organizing, and/or executing/ supervising all internal and external audits of Abbott Japan

• Coordinate with business teams for all post auditing activities and lead, drive the execution of corrective actions and preventive actions, ensuring the timely closure of CAPA actions.

• Perform Management Review and propose initiatives for quality performance improvement.

• Facilitate to ensure Quality management of Distributors per request.

• Provide or coordinate trainings on Quality Assurance requirements.

• Support and implement Division Quality projects for local site.

QUALIFICATIONS

Education

Minimum Bachelor degree in Life Science, Pharmacy or Nutrition/Food related discipline.

Background

• Prefer 3 or more years working in the quality management or related filed or positions.

• Experienced in roles/requirements supporting marketing authorization holder (MAH) or as Marketing Manager General specified in Japan GQP requirements.

Required Functional Competencies

• Business awareness

• Analysis/problem solving

• Teamwork

• Communication

• Research and investigating

• Result /Quality orientation

An Equal Opportunity Employer

Abbot welcomes and encourages diversity in our workforce.

We provide reasonable accommodation to qualified individuals with disabilities.

To request accommodation, please call 224-667-4913 or email corpjat@abbott.com