Assoc Dir., Clinical Quality Mgmt. Lead

Merck•Billerica, MA

About The Position

In your role as Clinical Quality Management Lead, you drive risk-based quality planning, execution, and oversight — and contribute directly to the integrity and success of our clinical trials. You'll play a key part in strengthening quality standards and inspection readiness, working closely with Global Development Operations and cross-functional study teams to make a real difference. This is your chance to bring your expertise, passion, and ideas to the table and help shape a best-in-class, risk-based quality culture at Merck KGaA, Darmstadt, Germany.

Requirements

Bachelor's/Master's in Medical or Life Sciences (PhD preferred)
8+ years of clinical development/operations experience
Deep expertise in QbD, clinical quality risk management & risk-based monitoring (ICH E6 R3)
Proven ability to lead GCP inspection readiness & support health authority inspections
Strong analytical mindset to identify trends and drive quality/process improvements
Excellent communication & influencing skills in complex, multinational matrix environments
Track record of successful CRO/vendor management and 3rd party oversight
Strong project & change management skills
Ability to work independently in fast-paced settings
External applicants must be eligible to work in the US.

Responsibilities

Drive risk-based quality planning, execution, and oversight for clinical trials.
Contribute directly to the integrity and success of clinical trials.
Strengthen quality standards and inspection readiness.
Work closely with Global Development Operations and cross-functional study teams.
Shape a best-in-class, risk-based quality culture.