Senior Specialist Quality Assurance

About the role

Job Description Senior Specialist, Quality Assurance: Principal Quality Auditor The mission of Quality Assurance is to: safeguard the rights and well-being of patients; the welfare of animals; comply with applicable global regulatory requirements through sound processes and procedures, and to provide independent assurance that delivers high quality data and clinical supplies. This position reports to the Director, Global Clinical Supplies Quality and is critical to maintaining the global clinical supply chain via disposition activities for clinical finished goods provided by our Company for worldwide clinical trials. Specifically, this includes batch documentation review ensuring our clinical supplies are in compliance with current Good Manufacturing Practices (cGMPs) regulations and relevant regulatory filing submissions. Areas of focus of this position revolve around the detailed workings of clinical packaging, labeling and distribution activities and associated regulatory submissions for Investigational New Drug applications and Clinical Trial Applications in relation to complex/niche supply chains and supply types for clinical protocols as well as Managed Access Programs, Joint Ventures/Collaborations, Independent Investigator-Initiated Studies, etc. Responsibilities may include, but are not limited to: Evaluation and disposition of clinical supply materials with the assurance that the materials were produced in conformance to all applicable policies/procedures of our Company and compliance with all governing regulations. Coordinate and/or support the preparation of procedures, processes and quality improvements. Leading projects to improve the performance of our processes, including continuous process improvements, investigation Corrective/Preventative Actions (CAPAs), and value capture projects that seek to improve outcomes, reduce cost, or lower our processing cycle times. Collaboration across cross-functional and business areas to ensure robust processing, continuous improvement and cross-functional team building. Assists in the coordination of significant quality events including fact finding, investigation, coordination of clinical quarantine and recovery actions. Providing on-the-floor coaching/guidance of operational and technical issues; providing immediate resolution on the shop floor to deviations and potential deviations. Managing investigations, change requests and project timelines to ensure key compliance and customer due dates are met; escalating any potential misses and develop remediation plans when possible. Education: Minimum of a Bachelor's degree with a technical emphasis in an appropriate scientific or engineering field. Required Experience and Skills: Minimum of 5-years' experience in the pharmaceutical or equivalent industry Good Manufacturing Practice (GMP) related field including Technical, Regulatory, Quality or Operations. Familiarity with clinical supply batch disposition (release), clinical supply operations, or regulatory filing activities. Prior experience authoring, reviewing or approving investigations, deviation management support, and Corrective/Preventative Actions (CAPAs). Background in quality control, quality assurance, auditing or regulatory affairs. Attention to detail, flexibility and an awareness of production and quality control problems. Effectiveness and creativity in approaching and solving quality and supply chain challenges. In-depth working knowledge of cGMPs and of regulatory requirements as they apply to the pharmaceutical field or a related area. Experience utilizing AI Tools for routine tasks and project work. Evidence of leadership skills coupled with highly developed oral and written communication skills, i.e., effective presentation of concepts and ideas, as well as interpersonal and conflict resolution skills. Demonstrated teamwork skills including ownership and accountability. Ability to experiment, learn, and adapt; pilot new concepts; demonstrated change management. Preferred Skills: Ability to independently manage multiple priorities and projects. Ability to lead and support teams of a cross-functional and multi-level nature, including senior management representatives. Demonstrated analytical and problem-solving skills. Knowledge of Lean Six Sigma and Project Management. Knowledge and competency in ERP/MES, Document management systems, SAP, PowerPoint, Excel, and Word. Required Skills: Adaptability, Adaptability, Animal Welfare, Audits Compliance, Clinical Trials, Continuous Process Improvement, Data Analysis, Detail-Oriented, Deviation Management, Employee Training Programs, GMP Auditing, International Regulatory Compliance, Interpersonal Relationships, Joint Ventures, Manufacturing Processes, Manufacturing Quality Control, Medical Supply Management, Preventive Action, Process Improvements, Quality Assurance (QA), Quality Assurance Systems, Quality Control Management, Quality Risk Management, Regulatory Affairs

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Company Intel

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