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 JapanCoordinate 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 awarenessAnalysis/problem solvingTeamworkCommunicationResearch and investigatingResult /Quality orientation