Assoc Dir., Clinical Quality Mgmt. Lead
Local Work Rights Required
This employer does not provide visa sponsorship. Applicants must already have the legal right to work in the job location.
This opportunity may still be relevant if you already have work authorization, are a permanent resident, citizen, student or dependant with work rights, or are seeking jobs within Africa.
Role Summary
Join EMD Serono as the Associate Director of Clinical Quality Management in Billerica, MA. Lead quality planning and oversight for clinical trials without sponsorship.
Key Responsibilities
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.
Minimum Requirements
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
- 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
Working Conditions
We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!
Apply now and become a part of a team that is dedicated to Sparking Discovery and Elevating Humanity!
Eligibility Criteria
Applicants must be eligible to work in the US. Sponsorship is not available.
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