Clinical Quality Operations Manager, Oncology

Job Summary Our Clinical Research and Pharmacovigilance team pushes 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. Responsibilities Operational Quality Management: Oversee the strategic implementation of "quality by design" principles in assigned clinical trials. Develop Risk Assessment and Categorization Tools and Quality Plans in partnership with the Clinical Trial Team (CTT). Perform quarterly therapeutic area‑level reviews of quality plans and risk mitigation approaches to identify signals or trends and provide feedback to the Clinical Quality Operations Lead (CQOL) and Head of CQO. Facilitate and oversee responses to audit and inspection observations. Analyze data across therapy areas to identify signals and trends, and implement process improvement strategies. Partner with CQOL to develop skillsets for recognizing and responding to new and emerging risks through technology. Maintain a profound knowledge of Good Clinical Practice (GCP) with respect to digital data management. Build and nurture effective working relationships with key stakeholders, linking Clinical Development, study teams, global business functions, and regional study management. Contribute to the standardization of Clinical Quality Operations procedures, tools, and templates to ensure consistency and seamless progression through the study lifecycle. Ensure comprehensive oversight of all activities delegated to third parties, including facilitating and monitoring CTT oversight of vendor development, reviewing and revising quality agreements with business partners, and ensuring essential elements of the quality management system are in place for studies conducted with non‑commercial organizations. Inspection Preparation and Management: Maintain current regulatory inspection knowledge related to GCP inspections worldwide, particularly from US FDA, EMA, UK MHRA, and emerging authorities. Lead and support GCP inspections worldwide, serving as Point of Contact for specific regulatory areas (e.g., FDA, EMA, NMPA). Monitor, interpret, and communicate key regulatory developments. Maintain awareness of filing schedules, potential future inspections, and ongoing inspection preparation activities. Develop, update, and maintain GCP inspection procedures and guidelines. Contribute to the development or revision of company policies, SOPs, and training materials. Manage strategies for GCP inspections across all phases of regulatory health authority inspections, ensuring consistent, professional, proactive outcomes. Coordinate a cross‑functional team (Quality & Continuous Improvement, GCTO Country Operations, PV, GRACS, IT) to support regulatory health authority inspections worldwide. Maintain and QC the global inspection tracking system that records all GCP inspections, findings, responses, and CAPAs. Serve as the subject matter expert and primary point of contact for inspection management, providing real‑time, proactive advice and guidance. Escalate significant inspection findings or compliance risks to senior management. Develop inspection management plans for each assigned inspection in collaboration with the applicable cross‑functional team. CAPA Management Support: Ensure timely implementation of actions related to audits and inspections. Track all inspection CAPA and regulatory commitments and verify evidence of completion. Maintain a repository of evidence for all regulatory health authority inspections. Provide guidance and support for country‑level sites requiring headquarters input. Other Activities: Provide input into GCP Quality and Compliance Council regarding the QMS, RACT, quality plans, and regulatory health authority inspection status and results. Escalate overdue CAPA commitments. Strengthen company programs/strategies (e.g., QCV) to increase inspection readiness. Lead, drive, facilitate, or support remediation, prevention activities as process improvement and training as needed. Education and Experience 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. Minimum of 6 years in clinical research, including at least 2 years developing and managing clinical quality systems and regulatory inspection management. Profound knowledge of clinical development programs, clinical trial processes, quality management systems, and quality control tools. Expert knowledge of GCP/ICH and worldwide regulatory health authority requirements. Demonstrated CAPA management solutions. Experience with risk management tools and processes within the clinical quality framework. Required Skills Superior oral and written communication skills in an international environment. Ability to manage and develop others, including formal performance management. Excellent project management, organizational, teamwork, and leadership skills with conflict resolution expertise. Ability to lead cross‑functional teams of business professionals within and outside the research division. Urgency for worldwide health authority inspection matters. Analytical, interpretive, and problem‑solving skills. Strategic, objective, creative, and innovative thinking. Proficient interaction with all levels of specialists and management, exerting influence to achieve results. Summarize key audit and inspection issues and deliver lessons learned. Preferred 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 Salary and Benefits Salary range: $142,400.00 - $224,100.00. Compensation may also include annual bonus and long‑term incentive, if applicable. Benefits include medical, dental, vision, insurance for employee and family, retirement benefits including 401(k), paid holidays, vacation, and compassionate and sick days. For more information, visit EEO Statement Our company is 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. For more information about personal rights under U.S. Equal Opportunity Employment laws, visit EEOC Know Your Rights, EEOC GINA Supplement. We are proud to embrace diversity and inclusion, encouraging respectful challenging of ideas and collective problem‑solving. #J-18808-Ljbffr MSD Malaysia