- Catalent (Manassas, VA)
- …cross-functional areas in regulatory requirements. The Associate Director , Regulatory Affairs will review change control for potential impact on client ... Associate Director , Regulatory Affairs Position Summary: Catalent...committed to a Patient First culture through excellence in quality and compliance, and to the safety of every… more
- Creative Financial Staffing (Columbus, OH)
- …and reporting systems ensuring compliance with appropriate GAAP standards and regulatory requirements. Maintains internal financial control and auditing ... in place to support effective program implementation and ensure the quality of financial reporting both internally and externally. Position Responsibilities:… more
- Catalent (Harman, WV)
- … regulatory SOP and cGMP guidelines.Manages processes to optimize quality performance and on-time delivery to insure customer satisfaction.Establishes annual ... Senior Director , Supply Chain Position Summary: The Senior ...limited to, purchasing, sourcing, logistics, warehousing, inventory management and control , material forecasting, functional capacity planning and sourcing, S&OP… more
- Catalent (Philadelphia, PA)
- Position: Director QualityLocation: Philadelphia, PAPosition Summary: The Quality function is to build, monitor, and sustain a robust and effective quality ... that delivers reliable, high- quality products that meet all customer and regulatory agency requirements and expectations. Components of the quality system… more
- Merck & Co. (Rahway, NJ)
- …will ensure products and processes are developed in accordance with applicable regulatory , quality , company, and customer requirements.-This position will lead ... management, FMEA, design verification, design validation, statistical sampling, and control strategyExperience with regulatory fillingsWorking knowledge of ISO… more
- Insmed Incorporated (Bridgewater, NJ)
- …in New York™, and Best Workplaces for Millennials™ lists.OverviewReporting to the Executive Director Quality GMP Compliance, the Director , Quality ... years relevant experience requiredExtensive knowledge of cGMPs and pharmaceutical manufacturing, Quality Control and Quality Assurance.Commercial drug… more
- Merck & Co. (Millsboro, DE)
- …state regulatory requirements for animal welfare, management of controlled substances, quality control testing according to GMP standards, and emissions ... DNREC, etc.) of animal facilities and program reviews is required.PurposeThe Associate Director /Attending Veterinarian will report to the Site Quality Head/… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- Position Summary The Director of Quality Operations provides direct support for all Manufacturing and Quality activities. This position supports the ... Investigations, Change Control , and CAPA(s)Work with Area Management to drive Quality Culture Providing Quality Assurance oversight in the Sterile production… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …around rare diseases and immune disorders.Summary Lead the implementation of the quality strategy closely aligned with the business strategy within one or more ... R&D QA. Within assigned GPTs, facilitate the implementation of a risk-based quality management process fully embedded through trial design, execution and submission… more
- Merck & Co. (Rahway, NJ)
- …seamless access to relevant information across multiple systems and platforms.Establish data quality control processes to ensure data accuracy, completeness, and ... disease-specific databases (eg, Cancer Genome Atlas).Stay informed about the availability, quality , and limitations of various data sources and their relevance to… more
- Aequor (Seattle, WA)
- …independent, great communication Experience working cross-functionally Position Summary: The Quality Assurance Document Control (QADC) Associate Specialist ... expressing Quality principles Position Reports to Jenna Walker - Associate Director , QA Training & Document Control Education: Bachelor's degree or… more
- Merck & Co. (Rahway, NJ)
- …and overall role administration. This role reports to Executive Director , SAP Platform Team. Primary Responsibilities: Leadership and StrategyProvide strategic ... practices.SAP Development DEV/OPSLead the SAP development team in delivering high- quality and efficient solutions.Define and enforce coding standards, development… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- Position Summary The Engineering Director is directly responsible for leading the Engineering team in the successful design, construction, and commissioning of ... strategies and policies and represent the company with customers and regulatory agencies.Directly responsible for the management of external professional Engineering… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and/or in collaboration with global colleagues. Relationships Reports to the Associate Director Product Quality . Regularly interfaces with multiple NN Quality ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...find better and more innovative ways to improve their quality of life. We're changing lives for a living.… more
- Merck & Co. (Durham, NC)
- …or review and approval of system commissioning and qualification documents, change control , automation incidents, Quality Notifications (QNs), and other key ... embrace an empowered team culture including significant interaction with manufacturing, quality , IT, and engineering groups. - The Senior Specialist for… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of data at Daiichi Sankyo including: the stewardship organization, data quality , metadata management, lineage capabilities and the data governance processes ... including advocating for good data governance, stewardship, data identification, and data quality to enable business outcomes. This role will consist of these… more
- Novo Nordisk Inc. (Boulder, CO)
- …Experience in project team collaboration & support. Experience with working with Quality Control & tracking testing requirements preferred Beginning knowledge of ... to support analytical and process development, the CMC team works alongside Quality , Regulatory , Technical Operations and RNAi Early Development professionals at… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …onsite based role with relocation assistance eligible for selected candidate.Relationships Reports to: Director of MSAT & Quality Control Number of ... to a better tomorrow for our patients. Ethics and quality are held in the highest regard, and a...report contains the technical merit and completeness according to regulatory expectations. This position will be responsible for operating… more
- Truliant Federal Credit Union (Winston-Salem, NC)
- …Credit Union. Responsible for vendor management and oversight, including execution of quality control plans and annual reviews.Develops and ensures budgetary ... and rewarded for all that they do. Purpose of the JobThe Director , Credit Administration is responsible for the overall leadership, performance, and administration… more
