Assoc Dir., Clinical Quality Mgmt. Lead

Biopharma Careers; Billerica (MA); On-site; USD 122,000 - 203,000; Full time

Benefits offered by this job

Health insurance

Paid time off

Retirement contributions

Job summary

Merck KGaA in Billerica, MA is seeking a Clinical Quality Management Lead to drive risk-based quality planning, execution, and oversight of our clinical trials.

You will strengthen quality standards, support inspection readiness, and collaborate with Global Development Operations and cross-functional study teams to shape a best-in-class quality culture.

Qualifications

• Bachelor's or Master's in Medical or Life Sciences; PhD preferred.
• 8+ years of clinical development/operations experience.
• Proven ability to lead GCP inspection readiness and support health authority inspections.
• Experience in CRO/vendor management and 3rd party oversight.

Responsibilities

• Drive risk-based quality planning, execution, and oversight of clinical trials.
• Strengthen quality standards and inspection readiness.
• Collaborate with Global Development Operations and cross-functional study teams to ensure quality and compliance.

Skills

Quality management

GCP/ICH

Risk-based monitoring

CRO/vendor management

Cross-functional collaboration

Education

Bachelor's/Master's in Medical or Life Sciences

PhD preferred

Job description

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 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.

• Benefits offered by the Company include health insurance, paid time off (PTO), retirement contributions, and other perquisites.
• Position may be eligible for sales or performance-based bonuses.

For more information.

The Company is an Equal Employment Opportunity employer.

No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law.

This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment.

Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately.

The Company will not retaliate against any individual because they made a good faith report of discrimination.