Quality Operational Excellence Lead

Merck Healthcare KGaA•Billerica, MA

About The Position

We believe that effective processes are the backbone of our success, and we are looking for a talented Operational Excellence Quality Lead to join our team. In this role, you will be responsible for analyzing, and optimizing GLP, GCP, and GVP related processes across the organization in close collaboration with Business Process Owners and cross-functional stakeholders. Evaluating current processes to identify inefficiencies and eliminate complexity will be a critical part of your responsibilities, along with creating detailed process maps and documentation to provide clarity for all involved parties. Collaboration will be essential as you engage with various teams to incorporate diverse perspectives into your designs. Additionally, you will establish process metrics to monitor process performance and drive continuous improvement in partnership with Business Process Owners and stakeholders. You will report to the Head of Central Quality Systems at R&D Quality and Risk Management (RDQRM).

Requirements

B.S. in a Life Science-related with 5+ years professional experience and expertise.
A minimum of 3 years of working knowledge of Good Clinical Practice (GCP), Good Vigilance Practice (GVP), and Good Laboratory Practice (GLP).
A comprehensive understanding of the drug development process and the regulatory environment, particularly in areas relevant to our Healthcare business.
Strong expertise in process design and optimization methodologies.
Excellent analytical skills with the ability to identify inefficiencies and propose effective improvements.
Proficiency in creating process maps and flow charts.
Strong collaboration and communication skills to work effectively with Business Process Owners and cross-functional teams.
Experience in training and change management during process implementation.
Familiarity with establishing process metrics for performance monitoring.

Nice To Haves

Professional experience in multiple international pharmaceutical organizations is a plus.

Responsibilities

Analyzing, and optimizing GLP, GCP, and GVP related processes across the organization in close collaboration with Business Process Owners and cross-functional stakeholders.
Evaluating current processes to identify inefficiencies and eliminate complexity.
Creating detailed process maps and documentation to provide clarity for all involved parties.
Engage with various teams to incorporate diverse perspectives into your designs.
Establish process metrics to monitor process performance and drive continuous improvement in partnership with Business Process Owners and stakeholders.