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ASSOCIATE DIRECTOR, QUALITY ASSURANCE
West Point, PA Job # QUA008174
With guidance from the vendor quality lead, contributes to the development of the vendor audit plan pertaining to quality oversight of clinical trial-based vendor services. Communicates the overall quality strategy to research business areas including the identification and assessment of risk as it pertains to ongoing vendor compliance to operational standards and regulatory requirements. Formal risk assessment criteria are employed to aid in the selection of vendors for the annual audit plan and requires frequent consultation with the various research business areas as well as assimilating data on the vendor's history of issues, current performance, and criticality of support provided to clinical trials. In addition, pro-active quality support is required through engagement on issues as part of vendor governance operational activities, serious quality issues investigations, and other venues where systemic trends may be identified. Suggestions for improved quality are communicated to both the research business areas and the supporting vendors. Collaborates on quality issues information sharing and tasks with other research business quality functions to enable achievement of quality goals at the clinical trial program level. A detailed understanding of applicable regulations and guidance is required along with the ability to rapidly assess a vendor's policies/procedures during audits. Vendor oversight methods and processes are employed to minimize and mitigate both operational and regulatory risks.
Primary activities include but are not limited to:
* Under the guidance of the vendor quality lead, provide support in the development of the MRL QA vendor audit plan pertaining to vendor services using formal risk assessment criteria aligned with MRL standards and regulatory requirements. Engage with the research business areas to obtain appropriate input to the plan and ensure that research business areas understand the strategy. * Independently implement the audit plan through execution of audit processes including audit scoping, audit conduct at vendor sites, and reporting of audit issues to MRL QA management and appropriate research business areas. * Engage in follow up activities related to audit outcomes including additional audit reviews/assessments, meetings with the research business areas and/or vendors, and identification of audit outcome metrics to be reported to the MRL vendor management function. * Requires subject matter expertise (SME) in the application of GCPs to vendors providing functional and/or centralized services in the clinical trials. Vendors may include functional service providers (FSP) for various clinical trial services (e.g. site monitoring, data management, biostatistics), Interactive Response Technologies (IRT) services, and electronic clinical outcome assessments (eCOA). * Involves engagement with research business areas as part of formal operational governance forums, input on vendor quality agreements, consultation on quality by design (QbD) processes and other ad hoc issues related to quality, and investigative interactions with other quality organizations in the research business areas. * Ability to evaluate vendor services for quality management systems, end-to-end operational data flow including data acquisition, data management, analysis, reporting, data transfers, and data reconciliation activities. * Build effective working relationships with key research business areas and vendor quality representatives. * Engages with business quality groups to assimilate program and/or protocol level events and activities impacted by vendor performance as part of serious quality investigations, quality trending, and quality oversight. * Conducts appropriate work in accordance with applicable and established Standard Operating Procedures (SOPs), applicable regulations, safety guidelines and company policies and procedures. * Contribute to the ongoing development of MRL QA operating standards, work instructions, and training materials to further develop competencies within the MRL QA Vendor group and any other MRL QA areas assisting in support of the vendor quality program.
Education Minimum Requirement:
* BS/BA Degree in relevant area with 10+ years of experience in the pharmaceutical industry
Required Experience and Skills:
* Extensive experience in clinical trial activities * Expertise in the GCPs with a focus on data management work flow * Fundamental understanding of technology used in support of clinical trials
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