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Familiarity with risk adjustment regulations and policies, including HCC/diagnosis code accuracy, diagnosis code submission, and Risk Adjustment Data Validation (RADV) Audit. We are looking for a Compliance Director with at least twelve years’ prior experience working in a leadership role in the health care industry, and strong familiarity with regulatory laws and compliance, including fraud, waste and abuse.
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Iridium is seeking a self-motivated Senior Mechanical Engineer to join the Iridium Product Engineering Team. As a member of the Product Development Team, you'll be responsible for technical product ownership to include product design, design support, product manufacturability, product sustainability, partner design integration, design validation, and product regulatory compliance.
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Be a Subject Matter Expert who provides high level technical direction in the following areas: Project Management Cell and Gene Therapy Capital Projects Facility Builds Tech Transfers Validation Life Cycle Commissioning and Qualification Quality, Regulatory, and Compliance Engineering Automation and Serialization Reliability, Maintenance, and Asset Management.
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Since integrating into Lundbeck in October 2019, Lu-SBP has supported commercial launch of Lundbeck’s first biologic product (Vyepti) and advancement of a growing biologics pipeline in collaboration with our Copenhagen-based Process Science & Validation Team. The Lu-SBP team leads and supports the development of new product candidates from cell line development through commercial validation of Drug Substance and Drug Product manufacturing processes.
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As a Validation Engineer at PSC Biotech, you will play a critical role in driving project success, while supporting validation planning, development, documentation, and execution, and ensuring regulatory standards and quality requirements are met.
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Prepares and analyzes detailed documents for validation and regulatory compliance, using applicable templates. Preferred SkillsAnalytical Thinking, Credit Risks, Data Analytics, Financial Analysis, Model Development, Operational Risks, Quantitative Models, Risk AppetiteCompetenciesBank Quantitative Analysis, Consulting, Data Gathering and Reporting, Effective Communications, Predictive Analytics, Quantitative Techniques, Regulatory Environment - Financial Services, TestingWork ExperienceRoles at this level typically require a university / college degree, with 5+ years of industry-relevant experience.
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2+ years experience in quality, quality systems or regulatory affairs in a regulated manufacturing industry or equivalent combination of education and experience. You will directly support and contribute to actions for the Change Management Board, Validation Review Board, Material Review Board, training program, Management Review, product release, FDA surveillance and site quality initiatives.
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The ideal candidate will possess a deep understanding of ESG rating systems, regulatory compliance frameworks such as the CSRD, and possess strong data management, communication, and reporting skills.
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Will be assigned and qualified in at least one of the following functions: Instructor Pilot, Check Pilot, Crewmember Training Program Administrator, Flight Safety Office, Regulatory Compliance and Voluntary Programs (FOQA, ASAP, VDRP), Limited Flight Inspection Qualification or Flight Validation.
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Act as the primary Quality reviewer on software verification and validation (V&V) documents for accuracy, clarity, consistency, completeness and compliance to applicable regulations and industry standards.
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Manage model governance activities and coordinate with Model Risk Management to ensure validation frameworks and controls comply with Navy Federal and regulatory standards. Support quarterly CECL process, managing data improvement and validation, and assisting CECL reserve determination preparation.
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We were founded in 2014, and since then, we've become the largest network of independent primary care in the country - helping practices, health centers and clinics deliver better care to their patients and thrive in value-based care.
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Monitor performance of quantitative models and support independent model validation efforts in accordance with the model risk management policy. Establish and document model implementation controls that satisfy model risk management, audit, and regulatory requirements.
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Maintaining documentation for key processes and model components across the team with a focus on standardization of processes that satisfy model risk management, audit, and regulatory requirements.
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Manage and supervise the execution of credit specialist component of external audit engagements of various clients, including Securities and Exchange Commission (SEC) registrants, in accordance with relevant regulatory and professional auditing and assurance standards.
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validation regulatory jobs in Mclean, VA
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