- Merck & Co. (Rahway, NJ)
- …change management.Familiarity with United States and European Union GMP and Safety compliance regulations.Ability to convert new drug product attributes and ... Engineering, Chemistry, Clinical Operations, Customer-Focused, Data-Driven Decision Making, Drug Product Development, Estimation and Planning, GMP Compliance ,… more
- Merck & Co. (Rahway, NJ)
- …Innovation, Mentoring Staff, Operating Models, People Leadership, Pharmaceutical Development, Product Design, Product Development, Regulatory CMC, ... and scaling-up the formulation, device, and manufacturing process.- Driving drug product design from the benchtop to current Good Manufacturing Practice (cGMP)… more
- Merck & Co. (Rahway, NJ)
- …global standards and procedures related to biologics, vaccines, and finished product ensuring compliance with regulatory requirementsActively participate ... Job DescriptionThe Quality Assurance Director will provide compliance leadership and...Inspection, Quality Management, Quality Management Systems (QMS), Quality Metrics, Regulatory Compliance , Regulatory Inspections, Vaccine… more
- Merck & Co. (Rahway, NJ)
- …Systems, Quality Management, Quality Oversight, Quality Risk Management, Quality Systems Compliance , Regulatory Compliance {+ 4 more}-Preferred Skills:Job ... as a quality spokesperson on a variety of Quality or compliance -related issues.Identifies trends and/or potential compliance gaps and proactively… more
- Merck & Co. (Rahway, NJ)
- …SummaryUnder the guidance of a senior leader, a Principal Scientist/ Director , has primary responsibility for developing value evidence strategies, and ... in their HTA submissions. The incumbent is expected to contribute to product development and marketing strategies throughout the lifecycle to ensure that … more
- Merck & Co. (Rahway, NJ)
- Job DescriptionCurrently we are looking for an Associate Director Packaging Engineer. Welcome to the teamOur Packaging Technical Operations (PTO) team is where we ... biologics, and vaccines. Be part of a dedicated team that thrives on compliance and robustness, driving excellence in logistics technology and making a meaningful… more
- Merck & Co. (Rahway, NJ)
- …and retaining diverse talent.Extensive knowledge of and hands-on work in applying regulatory guidance and quality standards related to product release and ... Scientists to deliver analytical solutions that enable and accelerate process and product development and manufacturing and ensure safety and quality of our… more
- Merck & Co. (Rahway, NJ)
- …Devices, Operational Excellence, People Leadership, Process Analytical Technology (PAT), Product Development, Professional Networking, Regulatory Compliance , ... entirety of our non-sterile and sterile clinical portfolio. The Director is responsible for ensuring cGMP compliance ...for always maintaining a state of inspection readiness.- The Director should be well engaged with regulatory … more
- Merck & Co. (Rahway, NJ)
- …Technology (PAT), Product Development, Professional Networking, Quality Standards, Regulatory Compliance , Regulatory Submissions, Results-Oriented, Risk ... for analytical development of candidates from the discovery interface, through first product registration.- -The Director will be responsible for a team… more
- Merck & Co. (Rahway, NJ)
- …& Scientific Affairs, Publications, Medical Directors, Medical Science Liaisons (MSL), Compliance , Product Development Team (PDT), CORE-Value Evidence Sub Team ... Job DescriptionThe Director , Global Scientific and Value Content-Healthcare Professional (Dir...and external business and information needs, as well as regulatory and compliance issues. Taking a leadership… 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
- Merck & Co. (Rahway, NJ)
- … product physical & financial flows, and awareness of regulatory , quality, and technical processes/ requirements.Primary activities include, but are not ... robust demand and supply plans to ensure customers receive the right amount of product at the right place, at the right time.This individual will spend approximately… more
- Merck & Co. (Rahway, NJ)
- …Compliance , Supply, Continuous Improvement, and Cost Management.--The Associate Director , External Manufacturing Operations will also assist in commercialization ... - Knowledge of lean principles, equipment design, and preventative maintenance.- Regulatory - Global regulations and compliance requirements governing… more
- Formation Bio (New York, NY)
- …early development through commercialization. You will oversee internal and external teams, ensure regulatory compliance , and play a key role in scaling our ... development, formulation, analytical methods, and technology transfer to manufacturing sites. Regulatory Compliance & Submissions Ensure all CMC activities… more
- Merck & Co. (Rahway, NJ)
- …equipment and processes for medical devices/drug delivery systems. Reporting to the Director responsible for this area, you will partake in medical device assembly ... understanding of medical device assembly equipment to enable development of product specific processes and controls with a focus on DFM/DFA principles.Understanding… more
- Eisai, Inc (Nutley, NJ)
- …exchange.Maintain scientific credibility and ensure operational excellence (20%) Ensure compliance with regulatory and other ethical guidelines relevant ... If this is your profile, we want to hear from you. The Associate Director (AD), Global Medical Affairs Training and Education is responsible for the planning and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Safety and PharmacovigilanceR&DVendors/ CROs/ third partiesHEOR/ RWEEpidemiology Legal and compliance Marketing/ commercialGMP QA/ Supply chain / Regulatory ... areas centered around rare diseases and immune disorders. JOB SUMMARYThe Senior Director , Head Medical affairs Quality Assurance in Global RD/PV QA is accountable… 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
- Ross Stores, Inc. (New York, NY)
- …learning opportunities and development for our teams\. **GENERAL PURPOSE:** The Director , Product Compliance & Regulatory Attorney will work as a member ... stakeholders on a broad range of topics and projects in the areas of product compliance , regulatory compliance , product safety, environmental, and… more
- Anywhere Real Estate (New York, NY)
- …member of the Global Information Security team, the Director of Risk & Compliance (Data Privacy and Regulatory Compliance ) will spearhead the global data ... development, and operation of technology systems and products. The Director will ensure that data handling practices and information...Foster a culture of data privacy, regulatory compliance , and audit preparedness across the Product … more
