Position Overview — Basic Functions & Responsibility
The Global Clinical Supply (GCS) organization is within the Research & Development Division and is accountable for managing the 'end-to-end' integrated clinical supply chain across the Research & Development Division's portfolio to enable the execution of any clinical trial using the Company's assets. GCS supports more than 300 Phase I-IV clinical trials run in-house, 400+ outsourced or run by partners, as well as the Company's ISS clinical trials (300+). GCS is accountable for the planning, sourcing, labeling, packaging and delivery of clinical supplies to clinical sites across more than 60+ countries, all in accordance with US and WW regulations, company policies and Standard Operating Procedures.
The Director, Continuous Improvement, will lead Continuous Improvement activities across the organization supporting a CI culture. The role will oversee both strategic and tactical improvement initiatives, kaizen workshops, and cultural activities and will support the roll out of significant metrics as key performance indicators (KPIs), contributing to the overall governance of the performance oversight in GCS. The role will ensure the education of the organization in continuous improvement and lean methodology, project management, change management, knowledge management, quality by design, and appropriate risk management in processes through coaching and mentoring belt candidates and trainees for the community of practice.
The leader will play a key role in talent development within his/her team but also the overall GCS organization.
Primary Activities
The Director, GCS Continuous Improvement, will be accountable for identification, prioritization, and execution of continuous improvement activities in GCS and across partner organizations, including, but not limited to, process improvement, change management efforts, and After-Action Reviews (AARs).
Additionally, the incumbent will engage a client group within GCS and be responsible for the implementation of continuous improvement culture, tools, and education across the organization. The Head, CI will closely collaborate across GCS, Global Clinical Trial Operations (GCTO), Global Development Quality (GDQ), Preclinical Development Sciences and Clinical Supply (PSCS), Procurement, Subject Matter Experts (SMEs), Data Management, Translational Medicine, and the Research & Development Division (including the Division's Quality Assurance/QA and IT).
Primary activities include, but are not limited to:
•Actively create a culture in which Continuous Improvement becomes the organizational norm.
•Process design/improvement projects/strategic initiatives across the organization.
•Continuously identifies opportunities to improve, simplify, standardize, and optimize processes in collaboration with functional areas.
•Analytics & Metrics - Develops and maintains performance, quality, and compliance related analytics and metrics (reports, dashboards, Key Performance Indicators/KPIs).
•Seeks ways to innovate and/or further automate the use of data and new capabilities.
•Identify, train and coach in lean concepts.
•Continuously evaluate opportunities for creating additional connectivity, and share learnings, between partner organizations.
Education & Experience
•Bachelor's degree or equivalent experience required.
•A graduate degree in a scientific discipline would be beneficial.
•A LSS black belt certification or equivalent experience is required.
•Extensive experience in facilitating kaizen workshops and leading complex projects.
•Understanding of clinical supply chain and clinical trials, including GCP & GMP.
Skills Include but Not Limited To
•A dedication to solving complex and challenging problems with a creative mind and imaginative strategies.
•Strong influencing and negotiation skills.
•Ability to lead, create future state, and deliver results.
•Over five years in the implementation of a variety of lean six sigma tools to evaluate and improve business processes with at least five years coaching and leading process improvement teams.
•Demonstrated ability to develop strong, trust-based, collaborative relationships to drive change and execute on priorities with a diverse group of stakeholders.
•Strategic thinking and independent decision-making abilities.
•Demonstrated ability to communicate clearly, effectively and tactfully to interact with different global professional levels and external stakeholders.
•Proven track record of successful deployment of continuous improvement projects, across different modalities and business units.
•Must have strong understanding of GMP, GCP, and data integrity expectations from regulatory agencies.
•Excellent written and verbal communication.
Required Skills: Business Process Improvements, Continuous Improvement, Continuous Improvement Activities, Data Analysis, Data Gathering Analysis (Inactive), Lean Methodologies, Lean Six Sigma (LSS), Lean Six Sigma Continuous Improvement, Lean Six Sigma Management, Statistical Data Analysis
Preferred Skills: Continuous Improvement Projects, Key Performance Indicators (KPI), Process Optimization
Location & Logistics
The primary location for this posting is: USA - Pennsylvania - West Point
The salary range for the primary location of this role is: $173,200.00 - $272,600.00. This range reflects the Company's reasonable expectation of the base salary applicable to this role at the time of posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.
Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days.
•Employee Status: Regular
•Relocation: Domestic
•VISA Sponsorship: No
•Travel Requirements: 10%
•Flexible Work Arrangements: Not Applicable
•Shift: Not Indicated
•Valid Driving License: No
•Hazardous Material(s): n/a
