Senior Manager, Criticality Analysis and Pqm Support
il y a 1 jour
The Senior Manager Criticality Analysis and PQM Support position provides Quality Assurance & Quality Engineering leadership for Criticality Analysis processes at Janssen. The role is responsible for the oversight to ensure the use of quality principles and tools to optimize and to drive operational and quality excellence across Janssen.
**Main Duties/Additional Duties/Sphere of authority**:
Principal Duties:
Leads the deployment of Criticality Analysis processes within Janssen. This role sets the strategic direction to seamlessly embed and continuously improve effectiveness and efficiency for the Criticality Analysis process into the Janssen GMP processes (e.g. process validation, technical transfers, quality investigations, equipment purchases, filing preparations). As process owner, provide education, mentor and training programs and serve as Qualified Trainer and any other applicable training programs.
Sets strategic direction and act as a SME on the execution of efficient processes ensuring compliance and consistency with ICH Q8, ICH Q9, ICHQ12 and ISO 14971 risk management principles. Remains current in knowledge, skills and industry trends and trains on new regulations, guidelines, procedures, and processes.
Partners to identify, lead and participate in improvement opportunities within Janssen by analyzing data and reports and managing and tracking project activities.
**Qualifications**:
**Analytics & Problem Solving and Innovation**:
Uses in-depth knowledge of analysis and problem-solving techniques to study reports, identify underlying issues or trends, and assess broader implications of the findings, based upon the interpretation of quantifiable data, to recommend appropriate solutions and seek strategic insights.
Optimally integrates with process partners (both internal and external) to evaluate and implement against innovation opportunities across a broad-sphere of responsibilities
**Performance Metrics and Continuous Improvement**:
Improve understanding of critical metric usage to own the development of achievable improvement goals to close identified gaps
Initiates to coordinate and guide others in implementing continuous improvement tools and approaches to large projects.
**Project Management and Organizational Change**:
Influences through others to make the case for change relevant and build support for proposed solutions.
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
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