- Repligen (Waltham, MA)
- …of 10 years of experience in a cGMP, ISO 9001, or ISO 13485 Quality Management System environment required.Minimum 5-8 years of experience mentoring and ... OverviewWe are seeking an experienced Director of Quality candidate to lead...release including deviation support, root cause analysis, customer complaint management , hosting customer/regulatory audits and Certificate of Quality… more
- Merck & Co. (Rahway, NJ)
- …or design controls areaKnowledge of US and global medical device and healthcare regulations, including FDA combination products cGMP, Quality System Regulation, ... Development Associate Principal Scientist - Development Strategy, Design Controls(Associate Director Equivalent) Our company's Device Development & Technology (DD&T)… more
- Merck & Co. (Rahway, NJ)
- …momentum, and an inspiring mission to achieve new milestones in global healthcare . The Biologics and Biopharmaceutics team is responsible for the research and ... portfolio. Within Biologics and Biopharmaceutics, the large molecule product development Director will influence the strategy, lead activities, and develop a team… more
- Merck & Co. (Durham, NC)
- …across a wide range of business activities.- Reporting directly to the Director , Supply Chain Management , the successful candidate's primary responsibilities ... Overview Our company in the United States and Canada, is a global healthcare leader with a diversified portfolio of prescription medicines, vaccines, and animal… more
- Eisai, Inc (Nutley, NJ)
- …(CQA) strategy including audit and inspection management and oversight of the Quality management system. This role is responsible for Good Clinical Practice ... Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is...is your profile, we want to hear from you. Director , Clinical Quality Assurance The Director… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …the most diverse and collaborative groups within the organization. From healthcare provider interactions and developing and implementing regulatory strategies with ... find better and more innovative ways to improve their quality of life. We're changing lives for a living....difference? The Position Position provides field coaching, mentorship and management to the field-based Medical Liaisons, and develops and… more
- Merck & Co. (Rahway, NJ)
- …proficiency in ISO 13485, ISO 14971-2019, and other relevant quality management systems.Qualifications:Bachelor's degree in Mechanical Engineering, Biomedical ... Job DescriptionJob Summary: -The Director , Combination Product Commercialization is a key leadership...testing, and process validation, with a strong understanding of quality management systems and regulatory compliance.Exceptional project… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …actionable insights to guide the business. Relationships Reports to the Director , Commercial Insights & Analytics. Internal relationships include close interactions ... staff that will assist in the project execution and management of specific research projects. May supervise junior market...channels Leadership And Development Capable of assuming role of Director CI&A when needed, such as representation on CI&A… more
- Merck & Co. (San Francisco, CA)
- Job Description Position Description: Associate Director , DSCS Digital Implementation Project ManagerWithin the Development Sciences and Clinical Supply (DSCS) ... with the DSCS Digital Leadership Team to drive the execution and management of DSCS Digital initiatives.Development Sciences and Clinical Supply (DSCS) enables Drug… more
- Merck & Co. (Upper Gwynedd, PA)
- …Scientist, CMC, R4 - Pharm Pre-approval Reporting to the Sr Director / Director /Principal Scientist/Sr Principal Scientist in Pre-approval Pharmaceutical CMC is ... acceptability and identification of potential risks.Lead the development, communication, lifecycle management and review of the CMC Regulatory Strategy Document for… more
- Merck & Co. (Rahway, NJ)
- …a lead GCS Planning program representative ) such as clinical development, regulatory, quality and other supply chain areas to negotiate timelines ,- strategies and ... program(s) ( ie Bulk Drug Product).- - Oversees all bulk drug supply management and ensures proper allocation of drug product as needed across studies within… more
- Merck & Co. (Rahway, NJ)
- …accelerate process and product development and manufacturing and ensure safety and quality of our products. The successful candidate will be accountable for ... cross-functional development teams to enable pipeline decisions. -The Executive Director , Biologics Analytical Research and Development (B-AR&D) is responsible for… more
- Merck & Co. (Rahway, NJ)
- …formulation and process development through process tech transfer, scale-up activities, quality investigations, change management , and authoring GMP standard ... product aseptic processing, equipment, and sterile technique.Experience in leading quality investigations and change management .Familiarity with United States… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionUnder the direction of a HEDS Executive Director , the Senior Principal Scientist, Health Economics leads a team of health economists and outcomes ... economists and outcomes researchers.Accountable for team prioritization and development of high- quality health economic models and tools to support market access,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …pull you in? Are you ready to experiment with us? The Position The Associate Director of Nephrology Key Opinion Leader Marketing will be a pivotal driver in shaping ... with brand/therapy area vision and message. Relationships Reports to Senior Director of Cardio Renal Marketing Responsible for providing interface with key… more
- Eisai, Inc (Exton, PA)
- …Quality Assurance, Quality Control, Regulatory, and CMC Program Management departments.The Associate Director of Biologics Operations maintains knowledge ... At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care… more
- Eisai, Inc (Nutley, NJ)
- …business decisions. Can apply financial analysis to build business cases that drive quality decision making and management processes.Travel is estimated at 30% ... Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is...your profile, we want to hear from you. The Director , HCP Marketing, Alzheimer's Disease will lead several core… more
- Insmed Incorporated (Los Angeles, CA)
- …Workplaces for Millennials™, and Best Medium Workplaces™ lists.OverviewThe Associate Director Medical Science Liaison will develop and maintain professional ... relationships with external healthcare practitioners to provide comprehensive medical and scientific support for the therapeutic area of PAH/PH-ILD. This position… 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …with strategic alignment Effective in fast-paced environments with a focus on quality and documentation Skilled in change management and guiding teams ... cutting-edge AI/GenAI technologies and developing AI/GenAI products to deliver high quality insights with speed and efficiency Promotes a culture of creativity… more
