The Associate Director, Clinical Quality Management is responsible for the development and maintenance of quality programs, systems, processes and procedures that ensure compliance with policies and that the performance and quality of services conform to established standards and agency guidelines. Incumbent will provide expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and agency guidelines to assure compliance. Works directly with operating entities to provide process analyses oversight on a continuing basis to enforce requirements and meet guidelines. Leads audit and inspection preparation, resolution of audit and inspection findings and liaises with auditing groups and inspectors through all stages of the audits. Coordinates legal requests in support of government investigations or litigations. Ensures the quality assurance programs and policies are maintained and modified regularly. Facilitates uniform standards worldwide and enables best practice sharing, thereby fostering the achievement of company s mission globally.
Oversee clinical quality management within the oncology business group supporting the clinical trials teams to proactively manage quality for Eisai trials, ensure adequate vendor oversight and address any quality issues as needed.
Support cross-functional colleagues in the development of responses for internal system audits and regulatory inspections that address identification of actual root cause and improvements needed to support preventing finding in future
Lead a group of process and system owners in reviewing quality oversight data related to critical processes to identify gaps in standards, procedures and technologies that are a risk to clinical trial quality
Work with cross-functional teams to develop, prioritize and implement quality plans based on the prospective data to reduce/mitigate risk to clinical trial quality
Participate in and/or lead forums and process improvement/system initiatives related to critical to quality processes such as essential document management, data management, trial management, investigational product management, etc.
Bachelor s Degree in relevant health care area; Master s Degree preferred
Minimum 8 years in the pharmaceutical or biotech industry and at least 5 years of direct experience in GCP auditing and inspections and 3 years in Clinical Development or Operations managing or supporting clinical trials
Prior experience in root cause analysis, risk assessment, and prospective indicators of quality issues is desired
Knowledge and understanding of Clinical Development Programs, Clinical Trial processes as well as quality management and control tools is required.
Experience in Oncology Therapeutic Area, specifically related to design of trials and therapeutic area knowledge.
Experience developing and delivering effective CAPA management solutions.
Strong communication and presentation skills and experience working in a global role required
Project management and organizational skills.
Excellent teamwork and leadership skills
Ability to lead cross-functional teams of business professionals.
Ability to analyze, interpret, and solve complex problems.
Ability to think strategically and objectively and with creativity and innovation
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