Our Biotech client is seeking an Operational Excellence Director (OpEx) who will act as the organization’s leader for OpEx deployment and business process improvement for the company. Incumbent is a change agent responsible for leading the organization into a data driven, team-oriented culture that embraces continuous improvement, and ensures the implementation of an OpEx methodology and mindset across the organization. Primary focus on the following areas: development of an OpEx culture, facilitate critical projects, oversight and governance of OpEx projects; Coaching/Training/Knowledge Management; and, Performance and Change Management. 

• Drive the regional implementation of the Minaris OpEx Program
• Embed an OpEx mindset across the organization and share best practices
• Build out a plan for skill development across the organization in alignment with projects
• Lead the Operational Excellence program to drive completion of critical projects/initiatives that add value to our business
• Partner with functional managers, Site Leadership Teams, and project stakeholders in driving select projects to meet business targets aligned with the site/regional objectives
• Enable teams through mentoring and coaching
• Develop content and conduct OpEx training sessions
• Owner of the OpEx Project portfolio and lead the OpEx Steering Committee meetings facilitating the OpEx program governance
• Lead change management initiatives
• Develop a mechanism to capture and track benefits/savings associated with operational improvement initiatives
• Monitor business and project activity to assure organizational improvement efficiency gains and cost savings
• Supervise non-direct reports project leads in executing continuous improvement projects; Associate Project Managers (entry level), Project Managers/Quality Engineers

REQUIREMENTS 

• Bachelor’s or advanced degree
• 5+ years in an OpEx or Business Excellence role within a regulated environment preferably in bio/pharmaceutical, biotechnology or life science industry; GMP environment; Commercial experience preferred
• Strong understanding of OpEx methodologies and/or Lean manufacturing principles
• Six Sigma, Lean, PMP or similar certification is highly desirable
• The ability to assist in developing, implementing and supporting lifecycle management on OpEx tools such as: Six Sigma (DMAIC), 7 Wastes/Value Stream Mapping, 5S, Visual Controls, Root Cause Analysis, Kanban, Kaizen events, including the following methodologies/tools: Value Stream Mapping, Control Plans, Mistake Proofing, Root Cause and Corrective Action.
• A record of accomplishments in continuous improvement initiatives/projects, team leadership and problem-solving; Experienced in change management methodology and deployment
• Demonstrated success initiating change and influencing at all levels
• Experience in strategic planning, process improvement, project execution, and data/business analytics
• Excellent oral and written communication skills including proven track record in meeting facilitation, training and presentation
• Experience in strategic planning, process improvement, project execution, and data/business analytics
• A proven record of accomplishments in continuous improvement events/projects, team leadership and problem-solving, demonstrated success initiating change and influencing at all levels. 
• Experience in change management and organizational transformation
• Strong data analytics capability
• Excellent oral and written communication skills including proven track record in facilitation, training, and presentation

Competencies

•  Demonstrated leadership abilities, and the ability to work in a matrixed and collaborative environment; Ability to lead through influence
• Strong interpersonal, communication, and analytical skills, capable of producing executive-ready presentations with little guidance
• An innovative, motivated, and independent leader with proven ability to work cross-functionally and drive accountability, proactive problem-solving skills
• Comfortable translating ambiguous direction and high-level goals into actionable projects/initiatives
• Bias for action and solutions; Ability to partner with leadership, managers, and process owners to execute on cross-functional goals
• Strong communication and presentation skills; deep experience of Lean, Six Sigma and/or equivalent OpEx methodologies
• Ability to manage and prioritize multiple tasks and deliverables
• Extensive project management experience
• Proficient as a facilitator for workshops & process improvements using continuous improvement methodologies  
• Must have the ability to work in a team-oriented environment and with clients
• Ability to be comfortable in a clean room environment
• Must utilize proper personal protective equipment (PPE)
• Some extended hours as required to meet deadlines and other team commitments.

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

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