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The Senior Analyst will work in Ally's Model Risk Management function under the direction of the Model Validation Director responsible for Qualified Analytical Tool (QAT) Validation. Interact with IT and other matrix partners to improve Model Risk Management and QAT Validation capabilities.
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Process Controls and Validation Engineers provide technical support to manufacturing, quality and CMC Regulatory for manufacturing processes from technology transfer and/or design transfer to post-commercial lifecycle management activities.
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Collaborate with cross-functional teams (process R&D, analytical development, supply chain, quality, clinical, regulatory, DMPK, and tox) to meet CMC and program goals. Extensive experience in late-phase drug product development and commercial development with CMC regulatory filings for the US (NDA), Europe (MAA), Japan, and China.
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Review audits and ongoing monitoring of DEA compliance, FDA compliance, PDMP compliance, OSHA compliance, HIPAA and HITECH compliance, and Boards of Pharmacy regulatory compliance, and compliance with client KPIs.
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Experience with cell and gene therapy tech transfer, scale-up, validation, and commercialization. Strong understanding of regulatory requirements and guidelines for cell and gene therapy manufacturing (e.g., cGMP, FDA regulations.
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Demonstrates knowledge of post-educational, private sector work in the financial services or bank regulatory areas required, including: Prepayment, credit risk, fair lending, default, Basel or fair lending modeling/modeling validation, advanced statistical and/or econometric modeling techniques and complex Excel-based spreadsheet models Statistical modeling assessing strengths and weaknesses.
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Demonstrates experience with macroeconomic and regulatory environment as they relate to financial institutions; A career in our Balance Sheet Management practice, within Financial Risk and Regulatory services, will provide you with the opportunity to help business leaders embed a proactive and dynamic risk management capability and mind set into their corporate business practices.
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Performs advanced blood banking (antibody titers, elutions), advanced microbiology (Mycobacterium (Acid Fast Bacillus) Identification and Sensitivities, Mycology Identification, Virology, Anaerobic Culture, Polymerase Chain Reaction testing), molecular testing, high complexity testing, recording workload statistics, quality management projects and obtaining data for validation studies.
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7 or more years of relevant experience in AML / BSA regulatory compliance, data analytics, data validation, risk management Experience working with KYC and AML data. 7 or more years of relevant experience in AML / BSA regulatory compliance, data analytics, data validation, risk management Experience working with KYC and AML data.
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As an Associate Director in the Integrated Bioanalysis team you will be delivering bioanalytical strategies, solutions and data for AstraZeneca biologics including new modalities subject to preclinical and clinical studies with focus on cell-based bioanalytical strategy, immunogenicity assessment, method development and validation, GxP Bioanalysis and Regulatory submission.
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The EFCC Financial Intelligence Unit (FIU) is responsible for the collection, analysis and surveillance of data sources relevant to the identification and investigation of unusual financial transaction activities.
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Strong experience in data research using SQL/SAS/R/Python for data analysis. Conduct data exploration, quantitative research and data mining to uncover money laundering patterns. Write SAS/SQL/VBA/Python code to extract data to perform data analysis and research for data integrity.
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Valuation modeling for price verification and model validation purposes: Value exotic products, e.g., weather derivatives and construct/validate valuation inputs for structured products, e.g., full-requirements/load following deals, long-dated deals.
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The Manager / Senior Manager, GMP Quality Control will work closely with cross-functional teams to assess, monitor, and enhance quality systems, ensuring that all GMP data adhere to relevant regulatory requirements.
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Ensure alignment of SOPs, policies, validation plans, and other internal documentation with industry and regulatory expectations such as ICH guidelines. Liaison with other departments including Manufacturing, Quality Control, Quality Assurance and CMC regulatory to support management of the process lifecycle.
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