Senior Manager, Business Process Office, Global Regulatory Affairs (GRA)
Takeda
3 days ago
Remote
United States
$137,000 - $215,270 USD yearly
Corporate Functions
How you will contribute
- Support planning and execution of continuous improvement and process optimization activities.
- Coordinate cross-functional efforts to support successful project delivery.
- Coordinate and monitor regulatory operational support from internal and/or external resources.
- Identify and track project risks, issues, and budget considerations.
Business Process Owner Network (BPON) Leadership
- Support standardized documentation, governance artifacts, and performance measures.
- Assist process owners with current-state assessments; identify inefficiencies, risks, and variability; develop scalable, compliant future-state improvements.
- Provide subject matter expertise in process design, operational execution, and regulatory excellence.
- Support learning and awareness of continuous improvement principles and methodologies.
Continuous Improvement Leadership
- Apply Lean, Six Sigma, and continuous improvement methodologies (DMAIC, value stream mapping, root cause analysis) to identify improvement opportunities across regulatory processes.
- Support cross-functional process improvement initiatives.
- Ensure initiatives have defined scope, deliverables, timelines, and success metrics.
- Support change management for adoption of improved processes, tools, and ways of working.
Governance, Metrics & Reporting
- Define and track KPIs to monitor effectiveness, efficiency, and compliance.
- Prepare data-driven reporting on initiatives, risks, and progress.
- Support alignment with GRA governance models, quality standards, and regulatory expectations.
Minimum Requirements/Qualifications
- Bachelor’s degree (Life Sciences/Business Administration or related); advanced degree preferred.
- 5+ years in pharma/biotech.
- 3+ years in Regulatory Affairs or drug development project management.
- Knowledge of Lean/Six Sigma/continuous improvement and KPI/metrics.
- Experience supporting regulatory operations/business process management/continuous improvement in a regulated industry.
- Experience leading complex cross-functional transformation.
- Ability to collaborate in cross-functional matrix environments.
- Familiarity with regulatory systems, compliance frameworks, and quality control.
- Strong analytical, problem-solving, communication, and stakeholder engagement skills.
Preferred
- Lean Six Sigma Green Belt (or equivalent).
- Experience in Business Process Office/CoE/PMO-like structures.
- Familiarity with regulatory systems, data, and digital tools for process optimization.
- Support planning and execution of continuous improvement and process optimization activities.
- Coordinate cross-functional efforts to support successful project delivery.
- Coordinate and monitor regulatory operational support from internal and/or external resources.
- Identify and track project risks, issues, and budget considerations.
Business Process Owner Network (BPON) Leadership
- Support standardized documentation, governance artifacts, and performance measures.
- Assist process owners with current-state assessments; identify inefficiencies, risks, and variability; develop scalable, compliant future-state improvements.
- Provide subject matter expertise in process design, operational execution, and regulatory excellence.
- Support learning and awareness of continuous improvement principles and methodologies.
Continuous Improvement Leadership
- Apply Lean, Six Sigma, and continuous improvement methodologies (DMAIC, value stream mapping, root cause analysis) to identify improvement opportunities across regulatory processes.
- Support cross-functional process improvement initiatives.
- Ensure initiatives have defined scope, deliverables, timelines, and success metrics.
- Support change management for adoption of improved processes, tools, and ways of working.
Governance, Metrics & Reporting
- Define and track KPIs to monitor effectiveness, efficiency, and compliance.
- Prepare data-driven reporting on initiatives, risks, and progress.
- Support alignment with GRA governance models, quality standards, and regulatory expectations.
Minimum Requirements/Qualifications
- Bachelor’s degree (Life Sciences/Business Administration or related); advanced degree preferred.
- 5+ years in pharma/biotech.
- 3+ years in Regulatory Affairs or drug development project management.
- Knowledge of Lean/Six Sigma/continuous improvement and KPI/metrics.
- Experience supporting regulatory operations/business process management/continuous improvement in a regulated industry.
- Experience leading complex cross-functional transformation.
- Ability to collaborate in cross-functional matrix environments.
- Familiarity with regulatory systems, compliance frameworks, and quality control.
- Strong analytical, problem-solving, communication, and stakeholder engagement skills.
Preferred
- Lean Six Sigma Green Belt (or equivalent).
- Experience in Business Process Office/CoE/PMO-like structures.
- Familiarity with regulatory systems, data, and digital tools for process optimization.