Work Location: Billerica, Massachusetts
Shift:
Department: HC-RD-DQ Clinical Quality Management
Recruiter: Leah S Westley
This information is for internals only. Please do not share outside of the organization.Your Role: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.
Who You AreMinimum Qualifications:- Bachelor's/Master's in Medical or Life Sciences (PhD preferred), 8+ years of clinical development/operations experience
Preferred Qualifications:- 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
Pay Range for this position: $122,200- $202,900
The offer range represents the anticipated low and high end of the base pay compensation for this position. The actual compensation offered will be determined by factors such as location, level of experience, education, skills, and other job-related factors. Position may be eligible for sales or performance-based bonuses. Benefits offered by the Company include health insurance, paid time off (PTO), retirement contributions, and other perquisites. For more information click
here.
