Clinical Quality Operations Manager, Oncology

Job Description Our Clinical Research and Pharmacovigilance team push the boundaries of global healthcare through research and innovation. Through clinical trials and surveillance, we ensure the safety and efficacy of our existing and pipeline products to produce safe, effective, innovative medicine. Overarching Tasks It is business critical that our Company receives consistent, accurate, high‑quality data from clinical trials conducted worldwide. In partnership with the Clinical Quality Operations Lead (CQOL) and Head of CQO, the CQOM is accountable for the execution of operational quality activities within the assigned therapeutic area. This includes operational quality management and inspection management activities. The CQOM will oversee headquarters clinical quality operations and support clinical trial teams within the assigned therapeutic area, to proactively embed quality into our Company's sponsored trials, ensure adequate vendor oversight and address any quality issues as needed. The incumbent will be accountable for the development of quality plans to implement quality by design within clinical development programs, using a risk‑based approach. The incumbent will be accountable for the overall strategy for maintaining ongoing inspection readiness as well as preparing for, managing and following up on regulatory inspections. Operational Quality Management The Clinical Quality Operations Manager is accountable for overseeing the strategic implementation of quality by design principles in assigned clinical trials. The CQOM will develop Risk Assessment and Categorization Tools and Quality Plans in partnership with the CTT. The CQOMs within a specific therapy area will collectively and periodically perform a TA‑level review of quality plans and risk mitigation approaches to identify emerging signals or trends and provide relevant feedback to the CQOL and Head of CQO. The CQOM will facilitate and oversee the responses to audit and inspection observations. In addition, the CQOM will work with peers to analyze data across therapy areas to identify signals and trends and then develop and implement appropriate process improvement strategies. In partnership with the CQOL, the CQOM will develop skillsets to recognize and appropriately respond to new and emerging risks through the use of technology, especially with respect to Good Clinical Practice in digital data management. The CQOM will build and enable effective working relationships with key stakeholders to ensure role clarity and business effectiveness, including ongoing partnership with our research division QA and acting as the link between Clinical Development, study teams, global business functions and regional study management. The CQOM, in partnership with peers, will contribute to the standardization of Clinical Quality Operations procedures, tools and templates to ensure consistency and seamless progression through the study lifecycle. The CQOM is accountable for ensuring comprehensive oversight of all activities delegated to third parties. Facilitating and monitoring CTT oversight of vendors. Development, review and revision of quality agreements with business partners. Ensuring that essential elements of the quality management system are in place for studies conducted with non‑commercial partners. Inspection Preparation and Management The CQOM is responsible for maintaining current regulatory inspection knowledge as it relates to Good Clinical Practice inspections by regulatory agencies worldwide, especially those conducted by key authorities such as the USA Food and Drug Administration, European Medicines Agency, UK Medicines and Healthcare products Regulatory Agency, and other authorities. Work with other therapeutically aligned CQOM to provide comprehensive oversight of the TA, maintain awareness of filing schedules, potential future inspections and ongoing preparation activity. Develops, updates, and maintains GCP inspection procedures and guidelines. Contributes to the development and/or revision of Company policies, SOPs and training materials. Develops the strategy for managing GCP inspections to ensure consistency and professionalism and achieve compliance outcomes. Ensures a cross‑functional team is fully informed and prepared to support any regulatory inspection worldwide. In collaboration with the Global Inspection Coordinator and Head of CQO, maintain a global inspection tracking system that records findings, responses and CAPAs. Acts as the subject‑matter expert and primary point of contact for relevant functional areas on inspection management. Escalates significant inspection findings or compliance risks to Company Senior Management. Develops the inspection management plan for each assigned inspection with the applicable cross‑functional team. CAPA Management Support Ensures that all actions and commitments related to audits and inspections are implemented in a timely manner and tracks CAPA and regulatory commitments. Maintains a repository of evidence of CAPA and commitment completion for all regulatory inspections. Provides guidance and support for CCQMs regarding country‑level inspection sites requiring HQ input. Other activities Provides input into the GCP Quality and Compliance Council regarding QMS, RACT, quality plans and regulatory inspection status and results. Assesses and provides input to strengthen company programs and strategies to increase Inspection Readiness. Leads, drives, facilitates and/or supports remediation, prevention activities as process improvement and training initiatives. Education B.A./B.S. or M.A./M.S. Degree or equivalent in a relevant health care area. Further formal education in quality management or business management is preferred. Prerequisites Minimum of 6 years in clinical research, including at least 2 years developing and managing clinical quality systems and managing regulatory inspections. Profound knowledge of clinical development programs, clinical trial processes and quality management systems and quality control tools. Expert knowledge of GCP/ICH and worldwide regulatory requirements. Experience delivering effective CAPA management solutions. Experience with risk management tools and processes within the clinical quality framework. Skills Superior oral and written communication skills in an international environment. Ability to manage and develop others, including formal performance management. Excellent project management and organizational skills. Excellent teamwork and leadership skills, including conflict resolution and discretion. Ability to lead cross‑functional teams of business professionals within and outside the Research division. Able to act urgently for worldwide health authority inspection matters. Ability to analyze, interpret and solve complex problems. Strategic and creative thinking. Ability to interact with all levels of specialists and management and exert influence to achieve results. Ability to summarize key issues from audits and inspections and develop and deliver lessons learned. Required Skills Adaptability, Clinical Quality Management, Clinical Study Design, Clinical Trial Planning, Clinical Trials Monitoring, Data Analysis, ICH GCP Guidelines, Medical Writing, Process Improvements, Regulatory Compliance, Risk Management, Strategic Planning, Strategic Thinking, Team Leadership, Training and Development US and Puerto Rico Residents Only Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. If you need an accommodation during the application or hiring process, please use the provided resource.

EQUAL EMPLOYMENT OPPORTUNITY STATEMENT

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. San Francisco Residents Only We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance. Los Angeles Residents Only We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance. Salary The salary range for this role is $142,400.00 - $224,100.00. The position within this range will be based on education, qualifications, certifications, experience, skills, geographic location, government requirements, and business needs. Benefits We offer a comprehensive package of benefits, including medical, dental, vision healthcare, other insurance benefits (for employee and family), retirement benefits, 401(k), paid holidays, vacation, and compassionate and sick days. Job Posting End Date 06/5/2026 Requisition ID

R397953

#J-18808-Ljbffr Merck