- Daiichi Sankyo, Inc. (Bernards, NJ)
- …s culture of excellence and compliance and working toward building a quality mindset with Medical Affairs.Support the Sr. Director 's Medical Affairs ... Affairs programs. This role involves deputizing for the Sr. Director , representing the Quality organization at senior...of the Quality Manual into an annual Quality Plan, including quality risk … more
- Merck & Co. (Rahway, NJ)
- …to the leader of Packaging and Combination Product Commercialization, the Director of Sterile Product Packaging Development is responsible and accountable for ... sterile development portfolio, and delivering on organizational unit priorities.-- The Director will be responsible for new product packaging development for vaccine… more
- Merck & Co. (Rahway, NJ)
- …sustained launch in alignment with the company's business goals, and quality and regulatory compliance .-Essential Duties and Responsibilities:Utilize extensive ... compliance with relevant regulatory standards.Ensure robust technical plans, risk communication, drive technical and programs decisions through the development… more
- Merck & Co. (Rahway, NJ)
- …sustained launch in alignment with the company's business goals, and quality and regulatory compliance .-Essential Duties and Responsibilities: Strategic ... compliance with relevant regulatory standards.Ensure robust technical plans, risk communication, drive technical and programs decisions through the development… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and fosters a culture that seeks to constantly enhance global regulatory compliance to meet signal evaluation timelines.Develop quality systems and procedures ... global role that will cover signal activity across all DS regions. The Associate Director of the Signal Management Center of Excellence (CoE) will lead the daily… more
- Insmed Incorporated (San Diego, CA)
- …Workplaces for Millennials™, and Best Medium Workplaces™ lists.OverviewReporting to the Executive Director of Clinical Quality Assurance, the Director of ... Clinical Quality Assurance (CQA) serves as a strategic leader managing quality and regulatory compliance related to GCPs, acts as quality lead on the… more
- Merck & Co. (Durham, NC)
- …is seeking a highly motivated individual for the role of Assoc. Director , Engineering.- This role will provide end-to-end support of manufacturing science and ... products including Drug Substance, Drug Product, and Analytics.-We are seeking an Assoc. Director to join our Live Virus Vaccine (LVV) team. The successful candidate… more
- Merck & Co. (Rahway, NJ)
- …all platforms (eg syringes, auto injectors, bottles, blisters) meet safety, efficacy, quality , and robust supply standards. Drive proactive risk management ... Job DescriptionDir, Engineering - Director , Assembly and Packaging Platform Technical LeadershipReporting into the Executive Director Packaging Technical… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionReporting into the Executive Director Packaging Technical Operations the Director Packaging Distribution, Components and Systems Center of ... compliant supply of commercialized products for the benefit of patients. The Director of Packaging Distribution, Components and Systems COE is integral to this… more
- Repligen (Waltham, MA)
- …Assurance.Maintain internal and external audit schedules; serve as host for site auditsMaintain risk -based strategy for overall Quality compliance across the ... OverviewWe are seeking an experienced Director of Quality candidate to lead... Network Leader, Chromatography & Proteins.ResponsibilitiesThe Director , Quality will be responsible for:Maintaining site compliance … more
- Merck & Co. (Rahway, NJ)
- …administrative processes.Support the development of GMP Documentation such as:- Risk Assessments, Batch Records, Sampling Plans, Qualification Documents, and ... with key stakeholders.Training skills: Ability to train employees in technical, compliance , safety, and environmental procedures; ability to write SOPs and technical… 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
- 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. SummaryThe Senior Director of Clinical Operations will manage clinical operations staff to ensure ... ongoing collaboration and communication with internal stakeholders. Detailing The Senior Director will ensure a robust communication plan including status and timing… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Management related topics and establishes the oversight model for timely and quality delivery and regulatory compliance of outsourced activities.- Ensures ... to database release, data review and cleaning, database lock), to ensure data quality /integrity and regulatory compliance - Ensures that Data Management Plans are… more
- Merck & Co. (North Wales, PA)
- …supply of commercialized products for the benefit of patients. The Associate Director of Equipment Engineering is integral to this mission. The successful candidate ... packaging process and equipment issues, optimizing processes, and ensuring compliance . Effective collaboration with site-based and above-site based functional teams… more
- Insmed Incorporated (San Diego, CA)
- …Women™, Best Workplaces for Millennials™, and Best Medium Workplaces™ lists.OverviewThe Director , Regulatory Affairs will serve as the regulatory leader on ... risks, interpreting regulations and providing guidance to ensure global regulatory compliance and the development of assigned programs in alignment with Insmed's… 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
- Merck & Co. (Rahway, NJ)
- …Estimation and Planning, Maintenance Supervision, Management Process, Manufacturing Quality Control, Manufacturing Scale-Up, Manufacturing Systems, Regulatory ... enhance data monitoring capabilities, and drive excellence in safety, compliance , supply, and productivity.Global Impact:Collaborate with colleagues across the US… 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
