- Merck & Co. (Upper Gwynedd, PA)
- …milestones through product development including assessment of the probability of regulatory success together with risk mitigation measures.-Lead development and ... Scientist, CMC, R4 - Pharm Pre-approval Reporting to the Sr Director / Director /Principal Scientist/Sr Principal Scientist in Pre-approval Pharmaceutical CMC is… more
- Insmed Incorporated (San Diego, CA)
- …Role Responsibilities):Establish and maintain a risk -based and scientific-based quality system to support GCP.Oversee regulatory agency inspections and ... Millennials™, and Best Medium Workplaces™ lists.OverviewReporting to the Executive Director of Clinical Quality Assurance, the ... Assurance (CQA) serves as a strategic leader managing quality and regulatory compliance related to GCPs,… more
- Merck & Co. (Rahway, NJ)
- …( our Manufacturing Division / our Research & Development Division ) such as Quality , Regulatory CMC, and technical functions, to ensure timebound progression of ... of integration and partnering for Pharmaceutical development/ CMC with Quality , Regulatory , Operations, Non-clinical, Clinical, and other functional… more
- Merck & Co. (Rahway, NJ)
- …Development Associate Principal Scientist - Development Strategy, Design Controls(Associate Director Equivalent) Our company's Device Development & Technology (DD&T) ... from early design concept definition through commercialization to support regulatory filing, product launch, and post-market surveillance.This position will interact… more
- Repligen (Waltham, MA)
- OverviewWe are seeking an experienced Director of Quality candidate to lead Repligen's Waltham, MA facility which has proven experience in the biotechnology ... deviation support, root cause analysis, customer complaint management, hosting customer/ regulatory audits and Certificate of Quality generation...in Waltham, MA and will report to the Sr. Director , Quality - Quality Network… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Director of Operations as part of the Technical Operations team based in Raritan, ... NJ. Role OverviewThe Director of Operations is an exempt level position working...multiple work centers within the facility to ensure high quality and compliant product supply and oversee production metrics;… more
- Merck & Co. (Rahway, NJ)
- …launch in alignment with the company's business goals, and quality and regulatory compliance.-Essential Duties and Responsibilities:Strategic Leadership ... collaboratively with receiving sites, drug product partners, and Technical Product Leaders, regulatory and quality .Provide Voice of Manufacturing input to early… more
- Merck & Co. (Rahway, NJ)
- …CMC and Regulatory in aspects of control strategy and filings, Quality and our partners in the commercialization and manufacturing is essential.The successful ... and retaining diverse talent.Extensive knowledge of and hands-on work in applying regulatory guidance and quality standards related to product release and… more
- Merck & Co. (Rahway, NJ)
- …( as a lead GCS Planning program representative ) such as clinical development, regulatory , quality and other supply chain areas to negotiate timelines ,- ... Optimization, Project Management, Project Portfolio Management (PPM), Publications Management, Regulatory Compliance, Risk Management, Sourcing and Procurement,… more
- Formation Bio (New York, NY)
- …bring new treatments to patients faster and more efficiently.About the roleThe Director , Procurement will be responsible for establishing and managing a strategic ... company. Monitor vendor performance and enforce contractual obligations to maximize service quality and efficiency. Partner with Legal, Quality Assurance and… more
- Merck & Co. (Durham, NC)
- …Review Meetings (with External Partner).-- Compliance:-Achieve compliance goals through a risk -based approach (Safety Regulations, Quality Assurance, Risk ... investment requirements, and provide Operations input into Supply and Quality Agreements.- Launch Supply Risk Mitigation:-Ensure External Partner… more
- Merck & Co. (Rahway, NJ)
- …pipeline programs using fed-batch and continuous manufacturing platforms. The Director , Biologics Process Development (BPD) within the Biologics Process Research ... and downstream processes that produce high yields along with superior product quality and allow speedy progression for clinical studies and commercial launch. The… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …rare diseases and immune disorders. Summary: The Senior Director , Head of RBQM ( Risk Based Quality Monitoring) sets the vision and strategy for the RBQM ... source data review. Lead the team to develop and implement metrics including Quality Tolerance Intervals, Key Risk Indicators, Key Performance Indicators, and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and propel data-driven decision-making.Promotes a culture of creativity and risk -taking, alongside developing processes that encourage experimentation and innovative ... but not limited to - Commercial, Patient Services, CMR (Clinical, Medical, Regulatory ), Finance, and Novo Nordisk global colleagues, to deliver data-driven insights… more
- USAA (Phoenix, AZ)
- …initiatives including but not limited to: oversight of procedures/process, accurate regulatory reporting and filing, document governance, risk control ... of what truly makes us special and impactful. The Opportunity As a dedicated Director , Underwriting Research , you will be responsible for Managing a team of staff… more
- Olema Oncology (San Francisco, CA)
- …feel better, longer. For more information, visit us at www.olema.com. About the Role Director , Regulatory Labeling As the Director , Regulatory Labeling, ... reporting to the Vice President, Regulatory Affairs and Quality Assurance you will lead the development of labeling for clinical supplies as well as development… more
- USAA (Phoenix, AZ)
- …area of responsibility. Develops and executes training plans tied to fraud risk management through understanding of regulatory and industry trends. Ensures ... the Bank Fraud Prevention organization, reporting directly to the Director , Fraud Intelligence. This role focuses on leveraging fraud...data analysis and/or AML. 4 years of fraud, compliance, risk , audit, or regulatory related experience with… more
- Mattel (El Segundo, CA)
- …brands, partners, and suppliers. The Team: The Global Quality , Safety, Regulatory Compliance, Governance & Risk , Consumer Services, and Sustainability & ... decision-making and supporting strategic end-to-end change management. In addition to supporting quality and regulatory compliance, this role will help foster… more
- RIT Solutions, Inc. (Wayne, NJ)
- Title: Program Director of Regulatory Reporting - Must have current Investment Banking experience Job Description: The Program Director will be leading large ... limited to FR-Y 15 and FR 2052A. The Program Director should have experience in managing large regulatory...Regulatory Reporting solutions with a focus on data quality , controls, and overall governance of the production of… more
- Wells Fargo (New York, NY)
- …risk calculations including full-revaluation VaR, and capital calculations for internal risk management and regulatory requirements such as FRTB-SA. The ... customers and company. They are accountable for execution of all applicable risk programs (Credit, Market, Financial Crimes, Operational, Regulatory Compliance),… more
