Senior Manager/Associate Director, OED Strategic Process Excellence Lead

Role Summary

The Associate Director/Senior Manager, OED Strategic Process Excellence Lead is accountable for continually optimizing the OED Development Operations’ end-to-end business processes, including leading working groups to identify and define process improvement opportunities, ensuring accurate process documentation, appropriate training and delivery mechanisms, content creation, compliance, and system implementation. The role acts as primary contact for iterative continuous process improvement and change management activities and communicates key information to leadership for alignment and endorsement.

Responsibilities

• Serves as Oncology Early Development (OED) Development Operations‚Äô process expert, knowledge leader and owner of process health for high complexity business processes throughout their life cycle; accountable for process performance oversight, decision-making, and maintenance activities.
• Maintains awareness of process health via periodic reviews/audits and listening sessions with stakeholders.
• Collaborates with global process owners to ensure alignment and transparency of OED‚Äôs outsourced operating model.
• Acts as subject matter expert for audits, inspections, and compliance activities.
• Coordinates SOP alignments, health checks, and compliance reviews with key stakeholders.
• Provides strategic input and supports ad hoc processes and initiatives.
• Leads continuous process improvements by identifying pain points and opportunities for efficiency; facilitates cross-functional teams to address issues and implement solutions, including updates to SOPs, functional requirement specifications, and training design.
• Defines, monitors and analyzes operational performance and compliance metrics and KPIs to demonstrate effectiveness and quality, identify improvement opportunities, and recommend solutions.
• Participates in process-aligned initiatives to drive transformational improvements; leverages process improvement tools to implement countermeasures that enhance efficiency, quality, and compliance.
• Establishes and maintains training programs capturing the skills and knowledge required to execute core processes.
• Ensures sustainability of improvements post-implementation by partnering with cross-functional leaders to define performance measurements and track success over time.

Qualifications

• Associate Director: 10-12+ years in Pharmaceutical, Healthcare, or regulated industry; 8+ with Masters, 5+ with PhD (required).
• 5+ years process management and continuous improvement experience preferred.
• Strong project management skills with the ability to adapt to unknowns and drive progress while delivering impactful presentations; experience in the process area of responsibility preferred.
• Experience with metrics to drive risk-based decisions and improvements; ability to analyze complex data and generate robust business cases and impact analysis.
• Recognized leader in standard business procedures, including project and change management practices, with robust understanding of GxP.
• Strong organizational, team-building, and communication skills; ability to navigate a complex matrixed organization and drive transformative change; demonstrated stakeholder management.
• Solid interpersonal and influencing skills to secure buy-in across functions.
• Comfortable with out-of-the-box thinking and challenging status quo.
• Understanding of Lean/Six Sigma; Black Belt and/or BPMP certificate or similar preferred.

Skills

• Process optimization
• Change management
• Stakeholder management
• Data analysis and metrics
• Training design and execution
• GxP compliance
• Cross-functional collaboration

Education

• Master‚Äôs degree required for Associate Director; PhD preferred depending on level; additional certifications in Lean/Six Sigma or BPMP preferred.