Assoc Dir., Clinical Quality Mgmt. Lead

<p> </p><p><span style="font-size:12.0px"><span style="font-family:Verdana, Geneva, sans-serif">Work Location: Billerica, Massachusetts<br>Shift: <br>Department: HC-RD-DQ Clinical Quality Management<br>Recruiter: Leah S Westley</span></span></p><p><br><span style="font-size:12.0px"><span style="font-family:Verdana, Geneva, sans-serif"><strong>This information is for internals only. Please do not share outside of the organization.</strong></span></span></p><p> </p><br><p style="margin: 0.0cm 0.0cm 8.0pt; line-height: 115%; font-size: 12.0pt; font-family: Aptos, sans-serif;"><strong><span style="font-family: Verdana, sans-serif;">Your Role:</span></strong></p><p style="margin: 0.0cm 0.0cm 8.0pt; line-height: 115%; font-size: 12.0pt; font-family: Aptos, sans-serif;"><span style="font-family: Verdana, sans-serif;">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.</span></p><p style="margin: 0.0cm 0.0cm 8.0pt; line-height: 115%; font-size: 12.0pt; font-family: Aptos, sans-serif;"> </p><p style="margin: 0.0cm 0.0cm 8.0pt; line-height: 115%; font-size: 12.0pt; font-family: Aptos, sans-serif;"><strong><span style="font-family: Verdana, sans-serif;">Who You Are</span></strong></p><p style="margin: 0.0cm 0.0cm 8.0pt; line-height: 115%; font-size: 12.0pt; font-family: Aptos, sans-serif;"><strong><span style="font-family: Verdana, sans-serif;">Minimum Qualifications:</span></strong></p><ul style="margin-top: 0.0cm; margin-bottom: 0.0cm;" type="disc"><li style="margin-top: 0.0cm; margin-right: 0.0cm; margin-bottom: 8.0pt; line-height: 115%; font-size: 12.0pt; font-family: Aptos, sans-serif;"><span style="font-family: Verdana, sans-serif;">Bachelor's/Master's in Medical or Life Sciences (PhD preferred), 8+ years of clinical development/operations experience</span></li></ul><p style="margin: 0.0cm 0.0cm 8.0pt; line-height: 115%; font-size: 12.0pt; font-family: Aptos, sans-serif;"> </p><p style="margin: 0.0cm 0.0cm 8.0pt; line-height: 115%; font-size: 12.0pt; font-family: Aptos, sans-serif;"><strong><span style="font-family: Verdana, sans-serif;">Preferred Qualifications:</span></strong></p><ul style="margin-top: 0.0cm; margin-bottom: 0.0cm;" type="disc"><li style="margin-top: 0.0cm; margin-right: 0.0cm; margin-bottom: 8.0pt; line-height: 115%; font-size: 12.0pt; font-family: Aptos, sans-serif;"><span style="font-family: Verdana, sans-serif;">Deep expertise in QbD, clinical quality risk management & risk-based monitoring (ICH E6 R3)</span></li><li style="margin-top: 0.0cm; margin-right: 0.0cm; margin-bottom: 8.0pt; line-height: 115%; font-size: 12.0pt; font-family: Aptos, sans-serif;"><span style="font-family: Verdana, sans-serif;">Proven ability to lead GCP inspection readiness & support health authority inspections</span></li><li style="margin-top: 0.0cm; margin-right: 0.0cm; margin-bottom: 8.0pt; line-height: 115%; font-size: 12.0pt; font-family: Aptos, sans-serif;"><span style="font-family: Verdana, sans-serif;">Strong analytical mindset to identify trends and drive quality/process improvements</span></li><li style="margin-top: 0.0cm; margin-right: 0.0cm; margin-bottom: 8.0pt; line-height: 115%; font-size: 12.0pt; font-family: Aptos, sans-serif;"><span style="font-family: Verdana, sans-serif;">Excellent communication & influencing skills in complex, multinational matrix environments</span></li><li style="margin-top: 0.0cm; margin-right: 0.0cm; margin-bottom: 8.0pt; line-height: 115%; font-size: 12.0pt; font-family: Aptos, sans-serif;"><span style="font-family: Verdana, sans-serif;">Track record of successful CRO/vendor management and 3rd party oversight</span></li><li style="margin-top: 0.0cm; margin-right: 0.0cm; margin-bottom: 8.0pt; line-height: 115%; font-size: 12.0pt; font-family: Aptos, sans-serif;"><span style="font-family: Verdana, sans-serif;">Strong project & change management skills, ability to work independently in fast-paced settings</span></li></ul><p style="margin-top: 0cm;margin-right: 0cm;margin-bottom: 8pt;line-height: 115%;font-size: 12pt;font-family: Aptos, sans-serif;"> </p><div id="tor__fextListingLayout_readOnlyDiv"><div id="tor__fextListingLayout_content"><div><div><div><p>Pay Range for this position: $122,200- $202,900</p><p> </p><p>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 <a href="https://careers.emdgroup.com/us/en/benefits" data-di-id="di-id-dcf68244-6999bb1d"><strong>here</strong></a>.</p></div></div></div></div></div><br><p style="text-align:justify"> </p><p style="text-align:justify"><span style="font-size:12.0px"><span style="font-family:Verdana, Geneva, sans-serif">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.</span></span></p><p style="text-align:justify"> </p>