Director Regulatory Affairs Process Excellence
North Chicago, IL
Location: United States - Illinois - Lake County
Industry: Pharmaceutical / Biotech
Director Regulatory Affairs Process Excellence Position Description:
The Director of Regulatory Affairs Process Excellence (DRA-PE) will champion and advance the implementation of a continuous improvement culture within the Regulatory Affairs (RA) department. The ideal candidate will utilize their knowledge of scientific, regulatory and business issues to enable products that are developed, manufactured or distributed to meet required law and regulation. The DRA-PE will report to the Senior Director of Regulatory Affairs Business Planning & Solutions to drive functional and cross-functional projects that embed lean six sigma and other continuous improvement principles across the organization. Candidates must be able to demonstrate the ability to drive the RA Business Process Owner model, and manage teams proactively to ensure alignment and consistency with business strategy while driving measurable process improvements throughout the organization.
Director Regulatory Affairs Process Excellence Major Responsibilities:
1.Manages a portfolio of process improvement projects across Regulatory Affairs (RA) and related functions.
2.Drives the process of identifying, defining, and prioritizing functional and cross-functional initiatives.
3.Effectively manages across projects in the portfolio to ensure alignment and consistency with business strategy and to drive measurable process improvements for the organization.
4.Identifies opportunities to improve quality, reduce cycle time, and increase operational efficiency.
5.Leads the planning and execution of high-impact process improvement projects.
6.Drives the Business Process Owner (BPO) effort to identify mechanisms to improve overall operational efficiency.
7.Develops, implements, and continuously refines a framework by which these SMEs can positive contribute to process excellence across Regulatory Affairs and related functions by proactively gathering and analyzing process-related metrics.
8.Identifies, prepares, and facilitates kaizen events and/or workshops to drive the identification and execution of process improvement initiatives.
9.Works alongside project managers from across Regulatory Affairs to drive additional process or capital initiatives that stem from the initial process improvement workshops.
10.Drives knowledge of process modeling and design across the organization.
11.Develops compelling value propositions and business cases for proposed initiatives.
12.Collaborates effectively with management, Subject Matter Experts (SMEs), Quality Systems, and peers to design cross-functional solutions.
13.Enables global regulatory compliance by defining and executing metrics and reporting protocols to monitor RA process effectiveness and compliance across the globe; directs staff in the collection and reporting of process performance metrics for new and ongoing initiatives.
14.Works independently in a role that demonstrates organizational influence within or across RA sub-functions and related functions.
15.Transforms concepts into executable initiatives, and drives definition of project scope, timelines and deliverables.
16.Seeks input from and forges agreements among sponsors regarding initiative goals and objectives.
17.Leads project teams effectively.
18.Escalates and drives resolution of project issues.
19.Demonstrates effective group facilitation skills and ability to drive consensus among team members regarding process changes.
20.May manage and/or mentor more junior team members/project managers.
Director Regulatory Affairs Process Excellence Requirements:
1.Education: Bachelor's degree in business management, information systems, engineering, math, science (e.g., biology, chemistry, pharmacy, medical), or related field
2.Preferred Education: Advanced degree in technical- o