Senior Manager/Associate Director, OED Strategic Process Excellence Lead

Role Summary

Senior Manager/Associate Director, OED Strategic Process Excellence Lead. Responsible for continually optimizing the OED Development Operations’ end-to-end business processes, leading working groups to identify and define process improvement opportunities, and ensuring accurate process documentation, training, delivery mechanisms, content creation, compliance, and system implementation. Acts as the primary contact for iterative continuous process improvement and change management, communicating updates to senior 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.
• Maintains awareness of process health by performing periodic reviews/audits and facilitating stakeholder listening sessions.
• Collaborates with global process owners to ensure alignment and transparency of OED‚Äôs outsourced operating model.
• Serves 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 and delivers continuous process improvements by identifying pain points and opportunities for efficiency; leads cross-functional teams to implement solutions, including updates to SOPs, requirements specifications, and training design.
• Defines, monitors and analyzes operational performance and compliance metrics to demonstrate process effectiveness and identify areas for improvement.
• Participates in process-aligned initiatives to drive transformational improvements and makes strategic decisions with cross-functional stakeholders; uses process tools to improve efficiency, quality, and compliance.
• Establishes and maintains training programs to capture skills and knowledge required to execute core processes.
• Ensures sustainability of improvements post-implementation by defining performance measurements and tracking 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 drive progress and deliver 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 insights and robust business cases.
• Recognized leader in standard business procedures, including project and change management; robust understanding of GxP.
• Strong organizational, team-building, and communication skills; ability to operate in a complex matrixed organization with a track record of transformative change.
• Solid interpersonal and influencing skills to collaborate across functions and drive outcomes.
• Comfortable with out-of-the-box thinking and challenging status quo.
• Understanding of Lean/Six Sigma principles; BPMP or similar certification preferred.

• Senior Manager: 8-10+ years in Pharmaceutical, Healthcare, or regulated industry; 6+ with Masters, 4+ with PhD (required).
• 5+ years process management and continuous improvement experience preferred.
• Strong project management skills with the ability to drive progress and deliver impactful presentations; experience in the process area of responsibility (preferred).
• Experience with metrics to drive risk-based decisions and improvements; ability to analyze data and generate insights and robust business cases.
• Recognized leader in standard business procedures, including project and change management; robust understanding of GxP.
• Strong organizational, team-building, and communication skills; ability to operate in a complex matrixed organization with a track record of transformative change (required).
• Demonstrated stakeholder management through communication and leadership with broad business orientation.
• Solid interpersonal and influencing skills to collaborate across functions and drive outcomes.
• Comfortable with out-of-the-box thinking and challenging status quo.
• Understanding of Lean/Six Sigma principles; BPMP or similar certification preferred.

Skills

• Process management and continuous improvement
• Project management
• Change management
• Data analysis and business case development
• GxP knowledge
• Cross-functional collaboration
• Training design and implementation