Performs internal audits of systems and manufacturing processes to ensure they are working properly and effectively to maximize the success of a product release. Writes audit reports summarizing findings, issues and recommendations for remediation or improvement, and brings failures to senior quality management for final action and decisions.
Develop and implement strategic goals and lead the efforts for late stage program strategies toward commercialization, including the design, coordination, and execution of process and product characterization and small and large scale validation studies.
The Data Manager III collaborates with various departments on the design, documentation, testing and implementation of clinical data studies. Develops systems for organizing data to analyze, identify and report trends.
Working closely with Clinical Operations Outsourcing team to oversee and coordinate all budgetary activities for assigned programs including project budget creation, forecasting, accruals reporting and invoice approval.
Leads investigations of deviations and develops and implements corrective actions at cGMP manufacturing facilities to enable department(s) to effectively deliver on all commitments while building a culture of Safety and Quality and continuous improvement.
Leads the development of a detailed cross-portfolio project plan, and interface with cross-functional representatives to identify risk mitigation, resource optimization, and acceleration strategies for individual programs.
Manages the team to ensure that priorities for lab scheduling, logistics and flow of activities for testing and review are established and followed and that workload is also prioritized and staffing is maximized to ensure timely and effective performance.
Collaborates with colleagues in clinical development and operations, research, bioPharma development and manufacturing, regulatory affairs, and product safety to participate in protocol development and the design of studies, statistical design, CRO selection and management, site monitoring, safety, clinical support of regulatory interaction, study reporting for new products that will ensure regulatory approval and commercial success.
Develops communication pathways and study specific processes to allow team members to communicate with clinical trial sites regarding all logistics including contract agreements, support materials and training and IRB/EC application process, including review of informed consent / HIPAA forms for conformance to pertinent government regulations.
Collaborate with colleagues in Clinical Development, Research, Product Development and Regulatory Affairs, external experts, and business partners in designing, implementing, conducting, and reporting of clinical trials including protocol development and the design of studies, statistical design, CRO selection and management, site monitoring, safety, and clinical support of regulatory interaction.
Lead early stage pipeline programs, including process development, scale-up, toxicology material production, raw materials strategies, technology transfer, clinical material manufacturing support, platform development and IND submissions, to support development of molecules leading to commercialization.
Perform medical review of safety events to ensure accuracy and completeness of safety information and consistency in medical coding; provide the company case assessment, and generate the analysis of similar events
Collaborate with internal stakeholders and advisors and lead cross-functional teams to successfully complete transactions that will drive significant value creation for the company and its shareholders.