- Responsible for the design of concept/mechanisms/process for the Janssen Japan R&D (JJRD) Quality and Compliance Management scheme.
- Drives strategies for quality processes relevant to pillars in the scope of the JJRD Quality Management System.
- Partners with quality stakeholders as applicable, to verify JJRD’s compliance state against applicable Quality Policies and Standards to ensure sound and sustainable quality state of JJRD. Develops and facilitates mechanisms/processes to identify potential gaps or opportunities for improvement and recommendations to meet Quality Policies and Standards.
- Independently manages projects meetings and activities including but not limited to process improvement, inspection readiness, and remediation in collaboration with direct manager, the department leadership team, and cross-functional business partners.
- Influences stakeholders and determines priorities, checkpoints, and timelines for all aspects of work and projects to achieve adequate progress. Effectively drives projects to completion.
Training & Development:
- Completes assigned training requirements promptly to ensure inspection readiness at all times.
- May be asked to provide mentoring, coaching and development to individuals in the department.
- Coordinates the common operation of Quality & Compliance Management Dept.
- Acts as a quality point of contact for JJRD innovation activity.
- Supervises junior staff and deputizes for Group Manager, as required.
- Performs other duties as assigned by department leadership.
- Minimum of 8 years (5 years for Sr Specialist) of previous Pharmaceutical Industry experience in R&D and/or quality and compliance area
- Thorough knowledge of the drug development process. Good knowledge of GCP/GPSP/GVP compliance regulations, research and development practices, scientific and quality terminology, and company quality standards
- Sound knowledge of the corporate structure and culture (including J&J, HCC, and legal and financial policies)
- Ability to translate data into information and strategies into executable action plans.
- Proactive strategic thinker
- Results and performance driven
- Highly committed to quality
- Flexible and persistent
- Logical thinking and problem-solving skills.
- Good conflict handling/resolution and negotiation skills
- Project management: Ability to independently plan, organize, coordinate, manage, lead and execute projects/assigned tasks
- Excellent presentation skills
- Excellent facilitation skills
- Time management skills
- Ability to operates in a (virtual) team environment.
- Must demonstrate strong personal leadership and competent interfacing with all levels of the organization including senior leaders
- Ability to apply knowledge of the ICH Guidelines; must be familiar with Japanese regulations (not only the Pharmaceutical Affairs Act but other regulations that govern clinical trials), FDA regulations, and the EU Clinical Trial Directive and regulations, as applicable
- Ability to apply advanced knowledge of Microsoft Office and applicable technical training tools (including Audio Response System and LiveMeeting)
- Proficiency in English (both oral and written)
A Bachelor of Science (BSc), Arts (BA), or equivalent degree
Janssen Pharmaceutical K.K. (7195)