Associate Clinical Quality Operations Manager, Oncology III

Job description

Job Description The Associate Clinical Quality Operations Manager (ACQOM) plays a key role in ensuring our company receives consistent, accurate, and high-quality clinical trial data worldwide. Working closely with the Clinical Quality Operations Lead (CQOL) and Head of CQO, the ACQOM supports operational quality management, risk management, inspection readiness, supplier oversight, and continuous quality improvement within assigned therapeutic areas. Key Responsibilities Clinical Trial Quality Support Support Clinical Trial Teams embedding Quality by Design (QbD) principles throughout clinical development programs. Conduct quality control activities to identify emerging study risks, process gaps, and quality issues. Review quality documentation and trial quality folders for completeness and accuracy. Assist with mergers, acquisitions, and integration activities to ensure knowledge transfer, risk mitigation, and inspection readiness. Risk Management Develop expertise in risk management tools and processes Review critical data and processes throughout the clinical trial lifecycle to ensure risks are identified, monitored, and mitigated. Regulatory Inspection Readiness Support sponsor and investigator-site inspections and help maintain ongoing inspection readiness. Participate in Inspection Support Teams (ISTs). Manage and track Corrective and Preventive Actions and regulatory commitments through completion. Perform quality reviews of inspection documentation repositories and support inspection response development. Analyze inspection outcomes for trends and lessons learned. Quality Assurance Audits Assist with audit preparation, facilitation, root cause analysis, response development, and CAPA management. Provide project management support for audit-related activities and CAPA implementation. Third-Party Supplier Oversight Support oversight of clinical research vendors and suppliers to ensure compliance and quality performance. Assist with quality agreements, audits, inspections, performance monitoring, issue resolution, risk management, and CAPA development. CQO Infrastructure and Continuous Improvement Contribute to process innovation and improvement initiatives. Develop advanced knowledge of global Good Clinical Practice (GCP) requirements, including ICH, FDA regulations, and EMA Clinical Trial Regulations. Education Bachelor's or Master's degree (or equivalent) in a relevant healthcare, life sciences, or related field. Additional formal education or certification in Quality Management or Business Management is preferred. Experience Minimum 4 years of experience in the pharmaceutical industry and/or clinical research. Knowledge of quality management and risk management methodologies is desirable. Understanding of clinical development programs and clinical trial processes. Experience with Quality Management Systems (QMS). Strong knowledge of Good Clinical Practice (GCP), ICH guidelines, and global regulatory health authority requirements. Prior experience conducting root cause analysis and managing Corrective and Preventive Actions (CAPAs). Key Skills & Competencies Communication & Collaboration Excellent verbal and written communication skills in a global environment. Strong teamwork and leadership abilities. Skilled in conflict resolution and handling sensitive matters with discretion. Ability to influence stakeholders and collaborate effectively across all organizational levels. Leadership & Project Management Strong project management and organizational skills. Ability to lead cross-functional teams within and outside the organization. Capable of driving initiatives and achieving results through collaboration and influence. Analytical & Strategic Thinking Ability to analyze, interpret, and resolve complex issues. Strong strategic thinking, creativity, and innovation skills. Ability to identify trends, risks, and key findings from audits and inspections. Inspection & Compliance Management Ability to act with urgency and effectiveness during global regulatory inspections. Skilled in summarizing audit and inspection findings and translating them into actionable lessons learned. Experience supporting compliance, quality oversight, and continuous improvement initiatives. Required Skills: Adaptability, Adaptability, Clinical Development, Clinical Research, Clinical Trial Development, Clinical Trials, Clinical Trials Monitoring, Clinical Trials Operations, Conflict Resolution, Data Analysis, Dedication to Patient Care, Ethical Standards, FDA Regulations, Good Clinical Practice (GCP), ICH GCP Guidelines, Inspection Readiness, Leadership Mentoring, Life Science, Mergers and Acquisitions (M&A), Project Leadership, Quality Assurance Processes, Quality Management, Quality Process Development, Regulatory Compliance, Regulatory Submissions {+ 1 more} Preferred Skills: Current Employees apply HERE Current Contingent Workers apply HERE Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: No relocation VISA Sponsorship: No Travel Requirements: No Travel Required Flexible Work Arrangements: Remote Shift: Not Indicated Valid Driving License: No Hazardous Material(s): NA Job Posting End Date: 08/20/2026*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.