ACCELERATING YOUR FUTUREThe Head of Learning and Continual Improvement is a unique opportunity. It is a new role on the U.S. Leadership Team - and it is deliberately crafted to empower the incumbent to create extraordinary value for our team and our partners by harnessing the power of collective knowledge to continuously drive improvement.
The incumbent will be responsible for managing and integrating three functions into a single closed loop system that identifies performance gaps and opportunities, reveals root cause and drives improvement. Those functions:
1. Operational Excellence: Identifies and removes barriers to performance through value stream mapping, Gemba, tiered performance management, structured problem-solving, Kaizen events and other tools and tactics
2. Investigations: Identifies structurally effective corrective and preventive actions through excellence in deviation, out of specification, out of trend, out of expectation and environmental monitoring root cause investigations
3. Training: Catalyzes, gathers, pools and diffuses internal and external knowledge across the organization to improve operational performance, decision-making, strategic planning and personnel growth
HOW YOU WILL MAKE AN IMPACT- General Leadership
- Participate in the creation of organizational objectives, goals and strategies
- Participate in monitoring organizational performance against plan
- Participate in identifying and driving action to improve performance and drive organization and partner value creation
- Mentor staff across the organization
- Develop relationships with our partners
- Operational Excellence
- Establish and continually improve operational excellence standards and tools for value stream mapping, Gemba, Kaizen, visual management, structured problem-solving, etc.
- Work with senior leadership to establish short, medium and long-term performance improvement targets, including, but not limited to, manufacturing success rate, yield, end-to-end turnaround time, capacity attainment and COGS
- Perform end-to-end value stream mapping to identify systemic constraints
- Collaborate with the Digital team to identify opportunities to apply digital and AI solutions to drive improvement
- Create and deliver transformation roadmap to achieve desired performance targets
- Identify partner needs; integrate into internal strategies and performance targets
- Build, manage and develop a high-performing operational excellence team
- Investigations
- Establish and continually improve the enterprise strategy, governance, standards, tools and capabilities required to deliver timely, scientifically rigorous and risk-based investigations and identify effective CAPA
- Establish investigation quality standards and effectiveness measures focused on root-cause quality, recurrence, investigation cycle time, CAPA effectiveness and organizational learning
- Define, monitor and improve processes for deviation, out of specification, out of trend, out of expectation, environmental and other investigations
- Convert systemic investigation findings into prioritized improvement initiatives
- Partner with Training to ensure investigation findings are translated into improved training, qualification and behaviors
- Build, manage and develop a high-performing investigations team
- Training
- Establish and continually improve the enterprise strategy and operating model for learning, training, qualification and capability development
- Establish role-based curricula, qualification pathways, proficiency standards and capability matrices for critical manufacturing, quality and support roles
- Proactively identify and translate external best practices, industry benchmarks, regulatory expectations, conferences, thought leadership, books and emerging technologies into actional learning that strengthens organizational capability, challenges ways of working and accelerates continuous improvement and innovation
- Create a "learning organization" in which knowledge generated through investigations, Gemba observations, improvement initiatives, lessons learned and performance trends is systematically captured, shared and incorporated into standards and training
- Build, manage and develop a high-performing training team
- Other duties as assigned
QUALIFICATIONS- Industry and Functional Experience
- 15+ years leadership experience within GMP manufacturing
- Experience working with and/or within a contract development and manufacturing organization
- Experience in cell and gene therapy is a plus
- Cross-functional experience (quality, regulatory, quality control, project management, commercial, etc.) is a plus
- Leadership Experience
- Experience leading operational excellence, investigations and training functions and/or programs
- History of designing, building, managing and growing teams
- History of mentoring individuals within and outside of one's reporting structure
- Experience leading organizational transformation programs is a plus
- Hands-on Experience
- Expertise in personally leading investigations and crafting effective CAPA
- Expertise in personally initiating and leading operational excellence initiatives and events
- Expertise in personally creating training strategies, creating training material and delivering training
- Skills & Training
- Bachelor's degree in Life Sciences, Engineering or related discipline
- Formal training in the Toyota Production System or other lean manufacturing discipline
- Strong understanding of performance management, analytics, digital transformation and emerging AI applications
- Strong problem-solving capabilities
- Strong oral and written communication skills
- Proficiency in Microsoft Office Suite (Excel, Word, PowerPoint)
Final compensation will be based on a variety of factors, including education, experience, technical expertise, specialized skill sets, market demand, internal equity, and business needs.
At RoslinCT, we offer more than just competitive pay. Our comprehensive Total Rewards package is designed to support your health, financial well-being, and professional development throughout your career. Benefits include medical, dental, and vision insurance, educational assistance, a 401(k) program, and a variety of additional resources to help you thrive both personally and professionally. 
