- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition Description:The Vice President, Regulatory Affairs, General Medicine, will contribute to the mission and vision of the Global Regulatory ... strategy with US FDA and global health authorities to advocate advanced regulatory strategies for novel medicines.Contributing to the continuous improvement of the… more
- Merck & Co. (Rahway, NJ)
- …design and development, manufacturing process development, qualification, validation, and design control and risk management techniques to positively support and ... Development, Product Development, Product Lifecycle Management (PLM), Project Management, Regulatory Interactions, Regulatory Oversight, Risk Management,… more
- Merck & Co. (Rahway, NJ)
- …Process Characterization, Process Control , Process Design, Process Optimization, Regulatory Submissions, Risk Consulting, Risk Management, Science ... and documentation of all stages of cell culture process commercialization. Risk assessment, control strategies, process comparability reports, Process… more
- Merck & Co. (Rahway, NJ)
- …management, FMEA, design verification, design validation, statistical sampling, and control strategyExperience with regulatory fillingsWorking knowledge of ISO ... from early design concept definition through commercialization to support regulatory filing, product launch, and post-market surveillance.This position will interact… more
- Merck & Co. (Rahway, NJ)
- …the disposition of API materials to ensure conformance to appropriate regulatory and company requirements for clinical supply manufacture and/or regulatory ... our Company procedures.- The Senior Specialist will become knowledgeable in regulatory requirements, cGMPs and our company's procedures to assure API manufacturing… more
- Aequor (East Syracuse, NY)
- …experience in the biopharmaceutical development process, GMP, PAT, CMC and regulatory guidance, ICH guidelines, and compendial requirements is desired. Experience ... and coordinating timely transfer of test methods with and to Quality Control laboratories is desired. Specific Knowledge, Skills, Abilities, etc. Strong written,… more
- Merck & Co. (Durham, NC)
- …goals through a risk -based approach (Safety Regulations, Quality Assurance, Risk Management, Deviation Management, Product Release, Change Control ).- Supply ... provide Operations input into Supply and Quality Agreements.- Launch Supply Risk Mitigation:-Ensure External Partner Site Readiness, Assist with Technology Transfer,… more
- Aequor (Thousand Oaks, CA)
- …of DP technical process, manufacturing operations, scientific method, basic regulatory compliance expectations, and quantitative / analytical troubleshooting skills. ... and implement the NPI project plan(s), being accountable for NPI scope, schedule, risk management, and leading matrixed teams through influence to meet NPI project… more
- Merck & Co. (Rahway, NJ)
- …expertise to optimize and fully characterize the enzyme manufacturing process control strategy across different scales.The successful candidate will play a pivotal ... candidate will provide scientific expertise by learning and utilizing Quality Risk Management methodologies and tools for statistical design of experiments. This… more
- Merck & Co. (Rahway, NJ)
- …of clinical development, as well as process characterization and regulatory filings for successful commercialization.Improve upstream processes by increasing ... prioritization, and problem-solving skills.Stay updated on the scientific and regulatory landscape; contribute scientifically and build your reputation through… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and QMS records.Build the Site Readiness of MES for FDA and/or Other Regulatory Audits / Inspections.This individual is responsible for the training of Manufacturing ... cGMP manufacturing and project planning experience preferred.Provide technical expertise of Change Control process as well as oversight of the MES team to ensure… more
- Wells Fargo (Phoenix, AZ)
- **About this role** **: Wells** Fargo is seeking talent to join the Business Risk Control and Regulatory Oversight team under the Chief Operating Office ... business at wellsfargojobs.com (https://www.wellsfargojobs.com/career-areas/) . **Business** **Overview:** The Business Risk Control and Regulatory Oversight… more
- Navy Federal Credit Union (Vienna, VA)
- …multi-faceted projects with cross-departmental impact + Advanced knowledge of operational and regulatory risk control concepts and practices + Proven ... and present to management and/or affected business unit summaries, operational and regulatory risk assessment reports, trending, and remedial or mitigation… more
- System One (Ashburn, VA)
- …projects simultaneously that have cross-departmental impact *Advanced knowledge of operational and regulatory risk control concepts and practices *Proven ... and present to management and/or affected business unit summaries, operational and regulatory risk assessment reports, trending, and remedial or mitigation… more
- Navy Federal Credit Union (Vienna, VA)
- …simultaneously that have cross-departmental impact + Significant knowledge of operational and regulatory risk control concepts and practices + Proven ... and present to management and/or affected business unit summaries, operational and regulatory third-party risk assessment reports, trending, and remedial or… more
- Shuvel Digital (Pensacola, FL)
- …projects simultaneously that have cross-departmental impact + Advanced knowledge of operational and regulatory risk control concepts and practices + Proven ... and present to management and/or affected business unit summaries, operational and regulatory risk assessment reports, trending, and remedial or mitigation… more
- HSBC (Buffalo, NY)
- …drive completion of control testing assignments to support operational, conduct and regulatory risk & control management + Effectively Delegate work ... in any discipline with strong academic background + Experience in control testing and risk management, internal control , or internal audit preferably within… more
- Deloitte (Morristown, NJ)
- …processes + Developing and implementing regulatory reporting policies, including risk and control assessments, operational and data controls, and data ... FR Y-15, FFIEC 009, or FFIEC 101 + Understanding of business processes, regulatory requirements, risk management, internal control management, process, data… more
- PNC (Pittsburgh, PA)
- …Reporting, Customer Risk , Decision Making, Regulatory Requirements, Risk Assessments, Risk Control , Strategic Objectives **Competencies** Decision ... opportunity to contribute to the company's success. As a Risk & Control Specialist - Conduct ...or governance role with exposure to conduct or operational risk issues. * Knowledge of regulatory expectations… more
- PNC (Pittsburgh, PA)
- …Reporting, Customer Risk , Decision Making, Regulatory Requirements, Risk Assessments, Risk Control , Strategic Objectives **Competencies** Decision ... opportunity to contribute to the company's success. As a Risk & Control Advisor within PNC's 2nd...challenge compliance with programs. + Coordinates and implements the risk management program to meet regulatory expectations.… more
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