- Daiichi Sankyo, Inc. (Bernards, NJ)
- …rare diseases and immune disorders. Summary The Non-Regulated Implementation Services Lead is responsible for the strategic oversight, planning, and execution of ... services are developed, implemented, tested, and integrated efficiently and effectively. The Lead will define and drive the methodology, approach, and best practices… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …requirements), including conduct of impact assessments and implementation of changes as required. Lead development and maintenance of RBQM standards such as ... other key drivers of enhanced quality.Aligns with the RBQM Risk Management Lead on critical-to-quality factors and study-level critical variables and processes, as a… more
- BAXTER (Round Lake, IL)
- …being top of the line regarding cleanliness and safety.What you'll be doingOversee and lead a maintenance team that could include mechanics and technicians to ... order, and maintaining clear communication channels. As a Facilities Maintenance Supervisor, you are a leader who is willing...with ability to interface well with other departments and lead effectively and efficiently in a team environment. Solid… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …organization to ensure smooth transition from system implementation to maintenance . Identify, assess, and mitigate technical, regulatory, and operational risks ... while ensuring these systems are inspection and audit ready. Overall accountability, ensuring higher quality project outcomes with optimal use of resources.- Provide such reports that are required to update both management and the business on the progress and… more
- Merck & Co. (Durham, NC)
- Job Description GENERAL SUMMARY The Engineering, Maintenance and Site Services (EMSS) organization continuously improve the reliability of the Durham Site operations ... the network.EMSS has an Associate Director opening for the Bulk Facility (GBF) maintenance team. The selected candidate will manage the engineering, maintenance … more
- Merck & Co. (Rahway, NJ)
- …Subject Matter Expert on all power generation equipment and processes. Lead power generation compliance program including continuous emissions monitoring.Supports ... capital project development, operational and maintenance planning, design, and commissioning. Establishes operational performance measurements, monitoring, and… more
- Genmab (Plainsboro, NJ)
- …this role, you will work in close collaboration with the Global Regulatory Lead (s) on a compound in late-stage development to implement the US regulatory strategy ... of the time. You will report to the Global Regulatory Strategy Team Lead .ResponsibilitiesThe responsibilities of the role will include, but is not limited to: Act… more
- Aequor (Devers, TX)
- …When applicable, lead the material dual sourcing strategy and Vendor Maintenance . Approved Supplier List and Material Qualification Support: Lead discussion ... Cell Therapy SAP Sourcing Migration Lead Devens, MA site Work Schedule: Monday -...Hybrid role Description The Cell Therapy SAP Sourcing Migration Lead is located in Devens, Massachusetts. This role will… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …Engineer (Clean Utilities), you will provide cross-functional support to operations, maintenance , quality and project teams for site GMP utilities. You will ... pneumatic improvements or changes that impact utilities or utilities maintenance .Support clean-black utilities equipment installation, qualification, start-up, PMs and… more
- Merck & Co. (Rahway, NJ)
- …Associate Director brings forward strong subject matter expertise to lead studies and evaluations, determine suitability, establish direction, conduct risk ... Project Management, Technology, our Research & Development Division Scientists, Maintenance , Automation, Plant Operations, and Safety), Engineering Firms, and… more
- Merck & Co. (Rahway, NJ)
- …and enhance the efficiency of our clinical research operations.Key Responsibilities:- Lead Data Management Initiatives:-Direct the development and maintenance of ... seeking a highly qualified and experienced Associate Director in Data Management to lead our data management team in supporting the pharm and vaccine veterinary… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …HCM Platforms and processes. This position will act as the functional lead with technical and operational expertise across multiple HRMS applications, possessing ... functional expert and advisor for implementation and ongoing management and maintenance of the Company's global HRIS system (ie, SAP SuccessFactors). Lead… more
- Merck & Co. (Durham, NC)
- …approach to problem solving, and be self-motivated to identify and lead process improvement projects. - Position Responsibilities Could Include: Reporting to ... batch records. Perform Quality retain sample management activities, if applicable. Lead Shopfloor audits to identify and address housekeeping and/or compliance gaps.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …partners with GRLs and Clinical Safety Pharmacovigilance (CSPV) leads in the maintenance of Company Core Data Sheets (CCDS) for assigned products. This position ... drives/leads the maintenance of global labeling and associated documents (including cartons...on timelines or resources, may assist another Global Labeling Lead by managing labeling development or approval for either… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …relationships with the QA team, Quality Control, Information Technology, Maintenance , Manufacturing personnel, Technical Operations personnel, Human Resources, Site ... Leadership Team members, and peers.Independently makes appropriate and compliant GMP decisions. Lead the establishment and improvement of QA practices to ensure… more
- Lovelace Biomedical Research Institute (Albuquerque, NM)
- …manage the daily operations of all campuses including coordinating building maintenance /preventative maintenance , directing repairs of equipment and systems, ... other related duties and tasks as required or assigned.The Manager will also lead and manage the Facilities Department staff to include identifying staffing needs… more
- Genmab (Plainsboro, NJ)
- …60% of the time per our hybrid policy.ResponsibilitiesReporting to the Team Lead of Regulatory Strategy, Global Regulatory Affairs, the key responsibilities include ... assigned project(s) and be responsible for the development, implementation and maintenance of US/global regulatory strategies (in line with Target Product Profile).… more
- Merck & Co. (Rahway, NJ)
- …and associated processes for growth opportunitiesThe Vocabulary Specialist may lead or participate in:Internal clinical data standards forumsStandards development ... associated with questionnaires.Understanding of lab values and the importance and maintenance of unit of measure conversions.Knowledge of versioning and … more
- Aequor (South San Francisco, CA)
- …monitoring tools and analysis, including but not limited to the development and maintenance of reports for study specific Key Risk Indicators (KRIs) and Quality ... Leads and study teams in selection, set up and maintenance of reports for Key Risk Indicators (KRIs), Quality...and dashboards, ensuring consistency by adopting applicable global standards. Lead and perform peer reviews and QC of the… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …products. Lead the validation team in the establishment and maintenance of validated systems. Coordinate technology transfer activities in support of ... Position Summary:Oversee and lead the validation program for production equipment and...methodically manage projects in a fast-paced manufacturing environmentAbility to lead a team of validation associates to prioritize and… more
