- Merck & Co. (Rahway, NJ)
- …in alignment with the company's business goals, and quality and regulatory compliance .-Essential Duties and Responsibilities: Strategic Leadership and Project ... Job DescriptionJob Summary: The Director , Combination Product Commercialization is a...of team members, fostering a collaborative and innovative team environment. Regulatory Compliance and Quality Assurance: Ensure that… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionReporting to the leader of Packaging and Combination Product Commercialization, the Director of Sterile Product Packaging Development is ... the sterile development portfolio, and delivering on organizational unit priorities.-- The Director will be responsible for new product packaging development for… more
- Insmed Incorporated (San Diego, CA)
- …strategy, identifying risks, interpreting regulations and providing guidance to ensure global regulatory compliance and the development of assigned programs in ... for Women™, Best Workplaces for Millennials™, and Best Medium Workplaces™ lists.OverviewThe Director , Regulatory Affairs will serve as the regulatory … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the Sr. Director , representing the Quality organization at senior levels. The Director plays a pivotal role in regulatory inspections, external audits, and ... and immune disorders. Job Summary: Reporting to the Sr. Director , Medical Affairs QA, the Director of...high impact projects, fostering s culture of excellence and compliance and working toward building a quality mindset with… more
- Merck & Co. (Rahway, NJ)
- …Medical Devices, Product Commercialization, Quality Management System Improvement, Regulatory Compliance , Regulatory Inspections, Social Collaboration, ... in alignment with the company's business goals, and quality and regulatory compliance .-Essential Duties and Responsibilities:Utilize extensive experience in… more
- Merck & Co. (Rahway, NJ)
- …Asset Regulatory Management Successfully collaborate and lead resolution of Regulatory , Reputational (ie Public Relations), Compliance and other Asset issues ... Job DescriptionThe Global Senior Director of Medical Affairs (GDMA) for Melanoma coordinates...valued co-strategist on the Global Franchise Team and assigned Product Development (Sub-) Teams. Contributes to Life Cycle Management… more
- Merck & Co. (Durham, NC)
- …Interpersonal Relationships, Lean Manufacturing, Management Process, Manufacturing Scale-Up, Regulatory Compliance , Root Cause Analysis (RCA), Strategic ... science and technology for commercial vaccine products including Drug Substance, Drug Product , and Analytics.-We are seeking an Assoc. Director to join… more
- Merck & Co. (North Wales, PA)
- …Budgeting, Project Management, Project Planning, Project Scheduling, Project Strategy, Regulatory Compliance , Results-Oriented, Risk Management, Software Project ... "oversight" is expected at this level. In addition, the Director may be expected to take on one of...in or lead continuous improvement projects that require extensive product development experience and understanding of procedures and policies,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …management processes across the global safety organization. The incumbent will ensure regulatory compliance , promote best practices, foster a culture of ... activities and fosters a culture that seeks to constantly enhance global regulatory compliance to meet signal evaluation timelines.Develop quality systems and… more
- Merck & Co. (Rahway, NJ)
- …lifecycle management, and continuous improvement initiatives to guarantee the robustness and compliance of our company's product portfolio across the internal ... relationships with internal stakeholders, including packaging commercialization, quality, analytical, regulatory , manufacturing, Device Development and Technology, Technical Product… more
- Merck & Co. (Rahway, NJ)
- …and drug product container closure systems including mold qualification and regulatory compliance .- To act as master data stewards and support enterprise ... Job DescriptionReporting into the Executive Director Packaging Technical Operations the Director ...and continuous improvement initiatives to guarantee the robustness and compliance of our company's product portfolio across… more
- Merck & Co. (Millsboro, DE)
- … product release, aseptic operations, formulation and fill/finish activities.Ensure compliance with corporate and regulatory requirements (cGMP/USDA) and lead ... teams, and who works effectively across functional partners.Quality- and compliance -focused with practical experience supporting regulatory inspections,… more
- Merck & Co. (Rahway, NJ)
- …and/or large facility builds or renovations.A thorough understanding of regulatory / compliance expectations across all phases of product development and ... Product Development, Estimation and Planning, Fast-Paced Environments, GMP Compliance , Innovation Processes, Life Science, Manufacturing, Manufacturing Process Improvements,… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionReporting into the Director , Logistics and Distribution Technology the Associate Director , Logistics and Distribution Technology will be ... for distribution and logistics of human health Drug Substance, Drug Product and Finished Goods globally.-The Packaging Technical Operations organization aims to… more
- Merck & Co. (Rahway, NJ)
- …Packaging Shipping Systems (Logistics and Distribution Technology)Reporting into the Director Packaging Distribution, Components and Systems COE the Director ... for distribution and logistics of human health Drug Substance, Drug Product and Finished Goods globally.- The Packaging Technical Operations organization aims… 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
- Merck & Co. (Rahway, NJ)
- …pipeline programs using fed-batch and continuous manufacturing platforms. The Director , Biologics Process Development (BPD) within the Biologics Process Research ... upstream and downstream processes that produce high yields along with superior product quality and allow speedy progression for clinical studies and commercial… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …teams, manage performance, and develop talent. Ability to create an engaged workforce.GMP Compliance & Regulatory Knowledge: Deep understanding of FDA, EMA, and ... in the treatment of multiple myeloma.Legend Biotech is seeking Director of Operations as part of the Technical Operations...within the facility to ensure high quality and compliant product supply and oversee production metrics; these metrics will… more
- Repligen (Waltham, MA)
- …, Quality - Quality Network Leader, Chromatography & Proteins.ResponsibilitiesThe Director , Quality will be responsible for:Maintaining site compliance ... OverviewWe are seeking an experienced Director of Quality candidate to lead Repligen's Waltham,...quality assurance team which includes all day-to-day activities for product manufacture, test and release including deviation support, root… more
- Merck & Co. (Rahway, NJ)
- …into the Director Packaging Platform Technical Leadership the Associate Director Medical Device and Combination Product (MDCP) Platform Packaging and ... lifecycle management, and continuous improvement initiatives to guarantee the robustness and compliance of our company's product portfolio across the internal… more
