Quality & Compliance
The CIA is responsible for the development and maintenance of the QCI dashboard. They will
collaborate with Functional Area Heads within QCI and partner areas within Global Clinical
Trial Operations (GCTO) to collect and report key quality metrics. The CIA responsibilities are
The CIA will collaborate with GCD Lead Subject Matter Experts (SMEs), MRL Quality
Assurance (QA), RCQMs and Clinical Quality Management staff. Work with HQ functional
areas and regional roles to evaluate and improve global and regional processes, compliance, and
quality-related performance and metrics.
Process & Performance Metrics
Responsible for tracking, analyzing and/or developing process, compliance, and quality-related
metrics (eg., Quality Control Visits, Country/Headquarters QC Plan, audits and inspection
findings) for Senior Management and regions. Liaise and lead with HQ functions and RCQMs
for development of global tools to enable prompt review data and self-checks as needed. Run
and develop analyses and reports for key stakeholders. Ensure global (plus regional and country
as appropriate) data are available and accurate across databases and tools.
Liaise and collaborate with Continuous Improvement function internally, GCD Lead SMEs, HQ
Functional areas, GCQM, HQ CQM, MRL QA, and GCTO regions throughout issue resolution
and/or risk mitigation on topics related to compliance, quality, audits, and inspections. Look for
opportunities to improve quality without jeopardizing operational efficiency in trial execution in
all levels with key stakeholders. Detect improvement needs, including training and improvement
in process design and execution.
Contribute to the design of company long-term Global Quality Management strategy together
with QCI colleagues, GCTO Senior Leadership Team (SLT), and other key stakeholders.
Support GCTO SLT and QCI in strategy planning by providing a data-driven overview of
current performance and known issues and risks.
Bachelor Degree or above is required in relevant area (e.g, life science, healthcare, or medicine)
with extensive experience in clinical research.
Minimum of 10 years of relevant experience in pharmaceutical industry, preferable direct field
monitoring and clinical trial execution. Certified Lean Six Sigma Green Belt (or with the
intention to be certified during the first few years in the position.) Knowledge and understanding
of clinical development and clinical trial processes as well as quality and understanding of
clinical development and clinical trial processes as well as quality management and control tools.
Experience in project management, business process improvement and innovation, with
demonstrated record of accomplishments. Direct experience in quality management, GCP
auditing and/or supporting GCP inspections.
Superior oral and written communication skills (in English) in an international environment.
Excellent teamwork, leadership and influential skills. Excellent analytical skill and meticulous
mind set to solve complex problems. Excellent consultative/facilitation skills with working
knowledge of operational excellence tools and methodologies. Ability to think strategically and
objectively and with creativity and innovation. Ability to work effectively in a culturally
diverse, remote environment.
Actively collaborate with Quality Improvement and Process Leads (QIPL) and MPI (Merck
Polytechnic Institute) for the development and implementation of clinical quality management
training programs for GCTO and Therapeutic Area staff.
Communication and Oversight
Collaborates to create clinical quality management tools and procedures for conducting Clinical
Trials at Merck investigative sites worldwide.
Clinical Trial Process Improvement
Collaborates with QIPL and Global Process Owners to initiate global clinical trial process
improvement projects and liaise with RCQM/CCQM for successful execution of these projects.