Janssen Pharmaceutical K.K is recruiting for a Manager in Audit Group, Quality & Compliance Management Department, located in Tokyo.The main job is to lead the end to end process of routine and non-routine audits/assessments of Janssen Japan R&D independently. This role is also expected to collaborate with BioResearch QA which is a global Quality Assurance Group and support them actively.
•Independently leads the planning, conduct and reporting of routine and non-routine audits of activities, Non-routine audits include for cause audits, as defined by the scope. Manages complex or business critical audits/issues in a supporting or leading role.
•Supports other auditors in planning, conduct and reporting of each audit.
•Ensures the relevant procedures, diagnostic tools, and audit plans are fully understood and applied in audit activities.
•Supports the CAPA process following the audit as needed.
•Encourages and supports others to properly manage and document the risk-based approach in the audit planning and conduct.
•Actively Supports BioResearch QA routine and non-routine audits/assessments.
•Participates in regulatory inspections as a member of Preparation Team and Core Inspection Team.
Training & Development
•Supports the Group Manager activity (e.g. developing the team training plan and team training) and provides training.
•Independently advises and coaches other auditors.
•Completes training requirements in a timely manner to ensure inspection readiness at all times.
•Able to supervise junior auditors/contractors.
•Deputizes for Team Lead, as required.
•Leads initiatives and actively participates in key projects across the organization or company. Interacts with key stakeholders and can influence and effectively drive projects to completion.
Subject Mater Expert/ Point of Contact
•Actively shares business area and regulatory knowledge/ expertise. May act as a primary contact for internal and/or external stakeholders.
•Independently provides consultation and advice to Business Partners on quality and compliance processes/procedures.
•Interprets and applies regulations/ policies to issues of moderate complexity, when required.
•Conducts impact assessment on regulatory changes and relevant procedural documents
•A Bachelor of Science (BSc), Arts (BA), or equivalent degree is required.
Experience and Skills:
•Preferably 8 years in an R&D and/or quality and compliance
•Expertise in GPSP and GVP
•Thorough knowledge of the drug development process
•Business level English
•Excellent communication skills
•Logical thinking and problem-solving skills
•Good conflict handling/resolution and negotiation skills
•Flexible and persistent
•Highly committed to quality
•Ability to leading audit skills
•Knowledge of auditing techniques
•Knowledge of CAPA management process
•Organized and detail oriented
•Proficient in Microsoft Office applications