Assoc Dir., Clinical Quality Mgmt. Lead

Merck Group$122K — $202K *
Healthcare
8 - 10 years of experience
Job Overview by Ladders

Qualifications

  • 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

Responsibilities

  • Drive risk-based quality planning and execution for clinical trials
  • Strengthen quality standards and ensure inspection readiness
  • Collaborate with Global Development Operations and cross-functional study teams
  • Develop and implement quality management strategies
  • Identify trends for quality/process improvements
  • Contribute to a risk-based quality culture at the organization
  • Prepare for and support health authority inspections

Benefits

  • Health insurance
  • Paid time off (PTO)
  • Retirement contributions
  • Additional perquisites
Full Job Description
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. 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.

About Merck Group

Merck Group Careers

There has never been a more opportune time to join Merck Group, a leading science and technology company in healthcare, life science, and performance materials. Merck Group offers a plethora of job opportunities that cater to a variety of skills and professional aspirations, making it an ideal environment for both seasoned experts and those at the start of their career journey.

Work You’ll Do

At Merck Group, every team member contributes to breakthrough innovations in healthcare, life sciences, and electronics. The company's commitment to diversity and innovation fuels its leadership in various sectors, driving growth and transformation globally. Merck Group’s career paths are diverse, offering positions that challenge individuals to use their skills in new ways every day, supported by robust training programs and development opportunities.

Explore Job Opportunities and Growth

Merck Group is not just about jobs; it's about building a career. With a vast array of positions, from research and development to marketing and sales, the company is keen on hiring and nurturing talent to lead industry transformation. Merck Group’s dedication to professional growth is evident in its comprehensive benefits package and performance management processes that aim to maximize individual potential.

Internship Programs

Starting with an internship at Merck Group can be a pivotal step in securing a prosperous career. Interns gain invaluable industry experience, working alongside seasoned professionals and engaging in projects that offer real-world applications of their studies. Internships often lead to full-time employment opportunities, providing a seamless transition from education to professional employment.

Inclusive Culture and Leadership

Merck Group is proud of its inclusive culture that embraces diversity and fosters an environment where all employees can thrive. The company’s leadership is committed to creating a workplace where diverse ideas lead to innovative outcomes. Merck Group also offers diversity training to ensure all team members are equipped to contribute to the company’s inclusive goals.

Networking and Professional Development

Employees at Merck Group are encouraged to engage in networking and professional development activities that enhance their career trajectories. The company hosts various networking events, workshops, and seminars that are designed to hone skills and foster connections within the industry. Leadership development programs are also a cornerstone, preparing employees for future roles of increased responsibility.

Stay Connected with Merck Group Careers

Interested candidates can explore open positions that match their skills and interests through the Merck Group careers page. The company values curious, creative, and solution-driven team players who are eager to make an impact.

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Merck Group is continuously looking for individuals who are ready to drive innovation and lead in the global marketplace. Whether through full-time positions, internships, or leadership roles, Merck Group offers a career path filled with opportunities for growth, learning, and leadership.
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