- Eisai, Inc (Nutley, NJ)
- …difference. If this is your profile, we want to hear from you. The Associate Director, Compliance Operations will be a key member of Eisai's US Ethics & ... Salary Transparency Language:The base salary range for the Associate Director, Compliance Operations is from :167,600-220,000Under current guidelines, this… more
- Merck & Co. (North Wales, PA)
- … Compliance , Regulatory Affairs Management, Regulatory Compliance , Regulatory Labeling, Regulatory Operations , Regulatory Submissions {+ 2 ... Job DescriptionThe Associate Director of Data Operations Management plays a pivotal role in driving...role is responsible for ensuring data integrity, accessibility, and compliance with regulatory standards, while also enabling… 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 ... of continuous learning, cross-training, and operational excellence.In partnership with Regulatory Operations , and/or third-party service providers, ensure high… more
- Merck & Co. (North Wales, PA)
- …IT Operation, Pharmacovigilance, Policy Implementation, Regulatory Compliance , Regulatory Labeling, Regulatory Operations , Regulatory ... Operations Lead is expected to understand the end-to-end regulatory submission process. The main focus will be on...industry experience, at least 6 of those in a regulatory and/or compliance area and experience with… more
- Capital One Bank (Riverwoods, IL)
- …system and process management initiatives, and for ensuring applications are in compliance with applicable regulatory guidelines and in accordance to the ... Equivalent CertificationAt least 6 years of experience in IT operations and system supportAt least 2 years of experience...and system supportAt least 2 years of experience in Project management At least 2 years of experience in… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …working closely with our QA organization to implement ongoing learnings from regulatory inspections.Engage and motivate Clinical Operations employees to execute ... review of regional / global policies and procedures. Ensure compliance with all Company and Regulatory requirements.Work...effectiveness and improved ways of working.Provide leadership to Clinical Operations staff and to project teams for… 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 ... 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,… more
- Merck & Co. (Durham, NC)
- …Product Management, Project Management Tools, Project Planning, Project Portfolio Management (PPM), Regulatory Compliance , Risk Management, ... every day thinking to mitigate risks Understanding and committing to Compliance Communication Ensuring inter- project communication and integrated execution… more
- Merck & Co. (Durham, NC)
- Job DescriptionOur Manufacturing Operations teams are the people that make our products. We work in the manufacturing plants with a "Safety First, Quality Always" ... and finished products.Our Engineers support internal and external manufacturing operations remain operational, continuously improve and innovate. With our extensive… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Quality organization at senior levels. The Director plays a pivotal role in regulatory inspections, external audits, and high impact projects, fostering s culture of ... excellence and compliance and working toward building a quality mindset with Medical Affairs.Support the Sr. Director's Medical Affairs Quality strategy by… 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 ... partners.Quality- and compliance -focused with practical experience supporting regulatory inspections, validations and cGMP operations .Required qualifications:Bachelor's… more
- Capital One Bank (Chicago, IL)
- …Services global payments network, platforms, technologies, and related operations (eg, credit/debit processing, digital payments, acquiring, servicing ... domestic/abroad, settlement operations ). We are seeking a candidate that has demonstrated...ecosystem related risks, as well as risk management and regulatory expectations for a large financial institution. This role… more
- Merck & Co. (Rahway, NJ)
- …Complete assigned work within established project timelines. Support GMP compliance and continuous improvement of laboratory operations . Manage laboratory ... including Analytical Development, Large Molecule Assay Validation, Quality Assurance, Technical Operations , and CMC Regulatory Affairs, to address technical… more
- Merck & Co. (Rahway, NJ)
- …development and execution. Knowledge of business functions including Technology, Manufacturing Operations , Finance, Regulatory , Quality, Compliance , Supply ... have direct impact on cost, quality, customer service, and compliance which ultimately affects access, continuity of supply, and...key investments across the product supply chain, assure key project execution, and drive year on year attainment of… more
- Capital One Bank (Chicago, IL)
- …global payments network, their associated platforms, technologies, and related operations such as(eg, credit/debit processing, authorization, clearing & settlement ... a candidate that has demonstrated knowledge of payments network operations and ecosystem related risks, as well as risk...ecosystem related risks, as well as risk management and regulatory expectations for a large financial institution. This role… more
- Merck & Co. (Rahway, NJ)
- …stakeholders, including Analytical Development, External Capabilities, Quality Assurance, Technical Operations , and CMC Regulatory Affairs, to address technical ... Job DescriptionScientist (R2) Biologics Analytical North American GMP Operations , Rahway, NJ - We invite individuals who possess a deep passion for promoting… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and establishes the oversight model for timely and quality delivery and regulatory compliance of outsourced activities.- Ensures inspection readiness of all ... data review and cleaning, database lock), to ensure data quality/integrity and regulatory compliance - Ensures that Data Management Plans are consistent and… more
- Merck & Co. (Rahway, NJ)
- …manufacturing sites, packaging & device development and technology teams, supply chain, operations , quality, analytical, regulatory , and project leaders. The ... platforms ensuring internal technical requirements are achieved and ensure filings with regulatory bodies to ensure compliance with relevant regulations and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and operations teams.Perform weekly clean space walkthroughs to ensure GMP compliance .Actively participate in all regulatory and internal audits of the ... seeking Facility Support Manager as part of the Technical Operations team based in Raritan, NJ. Role OverviewThe CAR-T...relationships with contractors to ensure quality of work and compliance with all company policies and regulatory … more
- Merck & Co. (Rahway, NJ)
- …as a liaison with respect to the Quality Management System and Compliance pillars of Global Development Quality for the purposes of investigations, corrective ... and Technical Units, including external suppliers.As required, participate in Regulatory Agency inspection activities.As required, participate as CSV Subject Matter… more
