RODRIGO HIRAMATSU GOMES
Bloomington
Summary
Dynamic Associate Director at Novo Nordisk Pharmaceuticals with a proven track record in stakeholder management and quality assurance. Expert in leading cross-functional teams to drive innovative strategies and ensure regulatory compliance. Adept at enhancing operational performance through continuous improvement and effective project leadership. Committed to maintaining high standards in quality management systems.
Overview
10
10
years of professional experience
Work History
Associate Director
Novo Nordisk Pharmaceuticals
Bloomington
11.2025 - Current
- Led cross-functional teams to develop innovative pharmaceutical strategies.
- Collaborated with stakeholders to align project goals and objectives.
- Managed regulatory compliance activities for new product launches.
- Facilitated training sessions for staff on best practices and procedures.
- Developed project timelines to ensure timely execution of key deliverables.
- Maintained positive relationships with stakeholders by responding promptly to inquiries, requests and complaints.
Maintenance Supervisor
Novo Nordisk
01.2024 - 11.2025
- Managed MTTR and MTBF metrics to enhance operational performance.
- Oversaw preventive maintenance initiatives to ensure equipment reliability.
- Acted as station owner, coordinating resources for efficient operations.
- Maintained line stability through rigorous monitoring and adjustments.
Process Supervisor
Novo Nordisk
06.2022 - 12.2023
- Managed deviation handling processes to ensure compliance with standards.
- Oversaw change control procedures to minimize risks and streamline operations.
- Directed DCC initiatives to optimize project outcomes and maintain quality assurance.
- Led area project responsibilities, coordinating resources and timelines effectively.
- Administered production management tasks to enhance efficiency and productivity.
Quality Professional
Novo Nordisk
01.2016 - 06.2022
- Approved deviations to ensure compliance with established standards.
- Managed change control processes to facilitate effective project progression.
- Oversaw DCC approvals to maintain quality and regulatory adherence.
- Evaluated potential recalls to mitigate risks and ensure product safety.
- Provided validation expertise to enhance process reliability and accuracy.
- Directed process group responsibilities to streamline operational efficiency.
- Administered QMS initiatives to uphold quality management system integrity.
Education
Bachelor of Science - Mechanical Engineering
Faculdades Integradas Pitagoras
Montes Claros - Brazil12-2017
Skills
- Quality mindset and GMP
- Stakeholder management
- People management
- Maintenance strategies
- Quality management systems
- Lean and Six Sigma methodologies
- Quality assurance (QA)
- Process supervision
- Continuous improvement
- Aseptic processes
- Validation expertise
- MTTR accountability
- MTBF accountability
- Preventive maintenance practices
- Station ownership responsibilities
- Line stability oversight
- Deviation handling expertise
- Change control management
- DCC oversight
- Area project leadership
- Production management strategies
- Deviation handling approval
- Change control approval
- DCC approval authority
- Potential recall approval authority
Focus Skills Strengths
- GMP: Quality Mindset
- Stakeholder Management
- People Management
- Maintenance
- Quality Management System
Timeline
Associate Director
Novo Nordisk Pharmaceuticals
11.2025 - Current
Maintenance Supervisor
Novo Nordisk
01.2024 - 11.2025
Process Supervisor
Novo Nordisk
06.2022 - 12.2023
Quality Professional
Novo Nordisk
01.2016 - 06.2022
Bachelor of Science - Mechanical Engineering
Faculdades Integradas Pitagoras