[innovative Medicine] Senior Supervisor, Operational Quality Group, Quality Operations Dept., Manufacturing And Supply Div. (fuji Plant)

Quality Assurance People Leader

Supervise members responsible for checking production records, determining shipments, and handling complaints. We will secure and provide the necessary support for the reliable execution of each process, and promote continuous improvement of each process.

Regulatory Compliance Responsibilities:

Quality Operations G Supervisors shall comply with laws and regulations related to ensuring the quality, efficacy, and safety of pharmaceuticals, medical devices, GMP Ministerial Ordinances, GCTP Ministerial Ordinances, Narcotics and Psychotropic Substances Control Act, and corporate policies and procedures.

Major Job Duties and Responsibilities:

• Supervision and support of manufacturing record inspection and shipment judgment process
• Ensure the quality of the records while achieving the completion of the shipment decision on time and on the pre-planned date.
• Assign or support the person in charge of the manufacturing record
• Coordination and support with relevant departments and personnel
• Reporting on various KPIs
• Proposal for improvement of processes, etc., or support for promoting improvement

• Overseeing and supporting the complaint handling process. Ensure that complaints reported to the Fuji Plant are addressed in a timely manner and promptly escalated to the SLT (Senior Leadership Team) as needed.
• Review and approve complaint-related records
• Reporting support for reporting events and various KPIs
• Proposal for improvement of processes, etc., or support for promoting improvement

Job Requirements

• Experience working in GxP regulated industries
• Preferably a degree in pharmacy, science, or engineering

Knowledge, Qualification and Skills:

• Sufficient knowledge of quality management systems (including record checking, shipment judgment, and complaint handling)
• Communication and negotiation skills
• Critical Thinking
• Investigation and causal analysis capabilities
• Business Conversation Level English/Japanese

Core Competencies:

• Collaboration, teamwork
• Solid Credo Values
• Customer Focus
• Emphasis on EHS Rules/Procedures Compliance
• Undelayed reporting of incidents, near misses, etc.

Required Skills:

Business Savvy, Compliance Management, Corrective and Preventive Action (CAPA), Cross-Functional Collaboration, Developing Others, Fact-Based Decision Making, Give Feedback, Human-Centered Design, Inclusive Leadership, ISO 9001, Leadership, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Risk Assessments, Standard Operating Procedure (SOP), Team Management