Assoc Dir., Clinical Quality Mgmt. Lead

EMD Serono, Inc.; Billerica (MA); On-site; USD 122,200 - 202,900; Full time

Benefits offered by this job

Health insurance

Paid time off

Retirement contributions

Job summary

EMD Serono, Inc. is seeking a Clinical Quality Management Lead to drive risk-based quality planning, execution, and oversight of clinical trials.

You will partner with Global Development Operations and cross-functional study teams to ensure robust quality standards and inspection readiness. The role requires 8+ years in clinical development, with deep QbD and risk management experience and strong communication in multinational environments.

Qualifications

• Bachelor's/Master's in Medical or Life Sciences; 8+ years clinical development/operations.
• Expertise in QbD, risk management, and risk-based monitoring (ICH E6 R3).
• Proven ability to lead GCP inspection readiness and health authority inspections.
• Strong analytical mindset to identify trends and drive quality improvements.
• Excellent communication and influencing skills in multinational matrix environments.
• Track record in CRO/vendor management and third-party oversight.
• Strong project and change management; able to work independently in fast-paced settings.

Responsibilities

• Drive risk-based quality planning, execution, and oversight of clinical trials.
• Collaborate with Global Development Operations and cross-functional study teams.
• Strengthen quality standards and inspection readiness.
• Lead GCP inspection readiness and support health authority inspections.

Skills

Deep expertise in QbD, risk management

GCP inspection readiness

Analytical mindset

Communication & influencing

CRO/vendor management

Project & change management

Education

Bachelor's/Master's in Medical or Life Sciences (PhD preferred)

Job description

Work Your Magic with us! Start your next chapter and join EMD Serono.

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\u2019s 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.

This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US.

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\u2019ll 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 Are

Minimum 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.

What we offer: 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!