**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