- Eisai, Inc (Baltimore, MD)
- …consistent application of global procedures and standards, and proactively assessing process performance for necessary optimizations. The Associate Director ... this is your profile, we want to hear from you. The Associate Director of Global Submission Management (GSM) is responsible for leading, managing, strategizing, and… more
- Merck & Co. (Rahway, NJ)
- …DescriptionAssociate Principal Scientist - Device Technical and Engineering Lead (Associate Director Equivalent) Our company's Device Product & Process ... expected to apply his/her knowledge of product design and development; manufacturing process development, qualification, and validation ; and design control and… more
- Insmed Incorporated (NJ)
- …and develop mitigation strategies CSV Program Oversight: Oversee the CSV team, validation strategy and continuous process improvementEnsure compliance with GxP ... to oversee cybersecurity operations, enterprise risk management, and Computer Systems Validation (CSV) program. This role will manage cross-functional teams and… more
- Merck & Co. (Rahway, NJ)
- …and Experience: Experience in drug development or manufacturing, including process or analytical development, characterization, technology transfer, validation ... Job Description Position Description: Associate Director , DSCS Digital Implementation Project ManagerWithin the Development Sciences and Clinical Supply (DSCS)… more
- Merck & Co. (South San Francisco, CA)
- Job DescriptionThe Executive Director of Metabolism & Obesity will be responsible for overseeing and facilitating the research in metabolic diseases & obesity and ... and retain a talented team that delivers on target identification & validation and advances CMD pipeline.Education Requirement:PhD, MD, or MD/PhD degree in metabolic… more
- Merck & Co. (Rahway, NJ)
- …timelines for site, filing, and launch readinessImproved access to product and process dataStreamlined transfer of process and product knowledge with reduced ... analytical development or commercialization, with knowledge of method development, validation , specification setting and justification. Practical knowledge of content… more
- Merck & Co. (Rahway, NJ)
- … process , and equipment, as well as qualification and validation .Demonstrated experience in a leadership role; managing technical teams supporting packaging ... Job DescriptionReporting into the Executive Director Packaging Technical Operations the Director ...Centers of Excellence including technical guidance to component or process changes, supporting tech transfers and investigations.- Develop and… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionReporting into the Director , Logistics and Distribution Technology the Associate Director , Logistics and Distribution Technology will be ... products for the benefit of patients. The Logistics and Distribution Technology Director is integral to this mission. The successful candidate will possess deep… more
- Merck & Co. (Rahway, NJ)
- …Packaging Shipping Systems (Logistics and Distribution Technology)Reporting into the Director Packaging Distribution, Components and Systems COE, the Director ... products for the benefit of patients. The Logistics and Distribution Technology Director is integral to this mission. The successful candidate will possess deep… more
- Insmed Incorporated (NJ)
- …and Electronic SignaturesExperience with GAMP 5 guidelines and validation lifecycle processesIT System Project managementExperience managing vendor relationships ... To request reasonable accommodation to participate in the job application or interview process , please contact us by email at ###@insmed.com and let us know the… more
- Insmed Incorporated (NJ)
- …future of science, we're in. Are you?About the Role:The Associate Director , Programming provides technical leadership and ensures adequate programming support for ... requirements, corporate and departmental SOPs and Work Instructions Leads process improvement initiatives Provides technical guidance to Insmed programmers,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Finance, IT, and operational teams. Relationships This individual will report to a Director in Finance & Supply Chain. Daily, the individual in this position will ... Finance organization with frequent interaction at the manager, senior manager and director level. Moreover, the job regularly interacts with IT and data management… more
- Repligen (Rancho Dominguez, CA)
- …growing Quality team. You will play a key role in oversight of validation activities, management of changes, and investigations/root cause analysis. This is an ... Rancho Dominguez, CA site and will report to the Sr. Director of Quality.ResponsibilitiesUse/application of investigative tools to perform investigations and root… more
- Insmed Incorporated (NJ)
- …possible for patients with serious diseases. Reporting to the Executive Director , Regulatory Operations, you'll be responsible for the publishing, management, and ... document authoring, review, approval, and publishing workflows.Conduct technical checks ( validation , bookmarking, hyperlinking) to ensure submissions pass regulatory agency… more
- Insmed Incorporated (NJ)
- …patients with serious diseases. In this role, you'll be reporting to the Director , Procurement Operations & SRM.The Insmed Summer Internship Program is designed to ... to support Insmed's Procure-to-Pay (P2P) transformation by assisting with data integrity, process analysis, and system readiness efforts as we prepare for the… more
- Fresenius Medical Care (Georgetown, KY)
- …schedules and goals. An individual contributor will have significant project/ process responsibilities. Program or project responsibility generally within the ... efficiency. Is aware of and develops a mechanism or process for knowing the specific situation of each patient,...for unexcused and missed treatments in collaboration with the Director . Plans, coordinates and acts as the liaison for… more
- SOFIE (Totowa, NJ)
- …a Product Development Specialist to lead the development, implementation, and validation of manufacturing and analytical methods for innovative diagnostic and ... pharmaceutical partners to bring new products from concept to reality-ensuring every process meets the highest standards of quality and regulatory compliance (21 CFR… more
- SOFIE (Somerset, KY)
- …Department | Radiopharmaceutical Contract Manufacturing (RCM) Reports To | Director , Radiopharmaceutical Contract Manufacturing (RCM) Pay | $75,000-$85,000( based on ... analytical methods on existing or new equipment. Author/Review/Execute qualification and/or validation protocols as needed. Author and manage change control related… more
- Fujifilm (Holly Springs, NC)
- **Position Overview** The Director , Process Validation plays a pivotal role in providing technical leadership and strategic vision within the Manufacturing ... collaboration to drive continuous improvement and adherence to regulatory standards. The Director , Process Validation is crucial in enhancing the site's … more
- Lilly (Indianapolis, IN)
- …expectations and business objectives. **The Senior Advisor/ Director , MSAT Global Process Owner for Sterilization Validation QMS is responsible for these ... Assurance function and capability to provide increased technical sterilization validation capacity across the network. **Position Brand Description:** + The… more
