Quality Operational Excellence Lead

The businesses of Merck KGaA, Darmstadt, Germany•Billerica, MA

About The Position

Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us. United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe. 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.

Nice To Haves

Experience in training and change management during process implementation.
Familiarity with establishing process metrics for performance monitoring.
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.