- Merck & Co. (Rahway, NJ)
- …apply regulatory and compliance requirements relevant to device risk management activities, ensuring adherence to industry standards. Lead risk ... Job DescriptionThe Associate Principal Scientist, Device Risk Management Lead , is... risk control measures, and performing overall device risk evaluations in compliance with ISO 14971… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …to make a difference? The Position This role directs and operationalizes NNI's Ethics & Compliance (E&C) risk management program by leading and managing four ... trends Collaborate with other departments to develop and implement risk mitigation strategies Lead the development and...Minimum of twelve (12) years of combined experience in risk management , ethics & compliance ,… more
- Genmab (Plainsboro, NJ)
- …policies; and (ii) the implementation and oversight of Genmab's third-party privacy risk compliance function. Successful candidates will have a deep ... the implementation of technical rules and standards for privacy compliance in data life cycles and deployment of technologies...oversight of Genmab data processors in accordance with Genmab's risk management framework and data privacy and… more
- Merck & Co. (Rahway, NJ)
- …manufacturing process development, qualification, and validation; and design control and risk management techniques to positively support and influence clinical ... engineering design, engineering analysis and testing, medical device design controls, risk management , test method/fixture development, design verification and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …capability to ensure processes are robust and continuously improving. Work with the Data Management and Integration Lead and Process Validation lead on the ... immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Associate Technical Lead as part of the Technical Operations team based in Raritan, NJ.… more
- Merck & Co. (Durham, NC)
- …or drug product. GMP experience with qualification of equipment. Experience with Quality Risk Management . Project Management experience in a highly regulated ... compliance with cGMP, regulations, and our Company's Quality Management System. Provide QA shop floor support in the...validation documentation as needed. May act as a Quality Risk Assessment Lead . - - Education Minimum… more
- Merck & Co. (Rahway, NJ)
- …Material(s):Required Skills:Measurement Analysis, Portfolio, Programme, and Project Support, Program Management , Risk Management , Stakeholder Relationship ... Job DescriptionWe are seeking a dynamic and experienced IT Infrastructure Lead to join our team. This is an exciting opportunity to contribute to our company's… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …Are you ready to realize your potential? The Position This position will lead a team of Validation Engineers and Validation Technicians, and is responsible for ... independent and maintains up-to-date knowledge of relevant standards and regulatory compliance requirements and independently contributes to the development of the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Affairs, Quantitative Clinical Pharmacology, Clinical Safety and Pharmacovigilance, Regulatory/ Risk Management , Quality Assurance, Medical Affairs, Translational ... Research, Informatics Services, Project Management and Operational Management . The Tech Lead must have the...architecture. Advocates for good architecture and design practices and compliance in all relevant areas. Assists IT and business… more
- Merck & Co. (Rahway, NJ)
- …across multiple workstreams to enable Compensation and Benefits and other related solutions. Lead end-to-end project management for HR Compensation and Benefits ... and other technologies. The Compensation and Benefits Product Manager will lead cross-functional teams in selecting innovative technical solutions aligned with our… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …study data protection, operational metrics, and clinical trial quality and risk management reporting requirements that adhere to programming standards ... in fast-paced environment, continuous improvement, project management , change management , and risk management .Responsibilities:Leadership, Direction, and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and application and other key drivers of enhanced quality.Aligns with the RBQM Risk Management Lead on critical-to-quality factors and study-level critical ... globally and with external parties as required.Champions 'Quality by Design' and Quality Risk Management approaches to quality management within Daiichi… more
- Tris Pharma (Monmouth Junction, NJ)
- …implement improvements, including CAPAs and CPIs, across departments as appropriateApplies quality risk management principles in the design (and resolution) of ... New Jersey, Tris has an immediate opening for a Manager, Quality Management Systems (QMS). Summary:The Manager, Quality Management Systems (QMS) supports,… more
- Merck & Co. (Boise, ID)
- …AHTS R&D / Tech Lab with complicated application packaging requests and risk assessments.Engineer IT solutions for remote AHTS field users using various tools ... as required.Complete special projects for Biomark and IdentiGEN as required Globaly.Act as the lead IT representative to gain the voice of the customer for AHTS R&D… more
- Merck & Co. (Rahway, NJ)
- …or facilitating teams involving source area representatives in a matrix management environment).Identifying trends and/or potential compliance gaps and ... and leading cross-functional contractor performance reviews as the quality lead for the oversight platform,Supporting product development teams in outsourcing… more
- Merck & Co. (Rahway, NJ)
- …policy.- The role will also be responsible for proactive resourcing planning, risk assessment strategies and budget management as necessary. The candidate ... Biopharmaceutics, the large molecule product development Director will influence the strategy, lead activities, and develop a team whose roles include design and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Clinical Operations on the DS/CRO Joint Operating Committee. Work with Process Excellence and Risk Management to ensure oversight plans are in place for all ... as programs or franchises.When sitting on a study team, lead the study team to develop a cross-functional, integrated...Daiichi Sankyo's quality measures. Leads the creation of the Risk Identification and Management Log (RIM Log)… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …feasibility, and implementation of study objectives. Implement and use efficient project management tools, eg, Communication Plan and Risk Based Quality ... Associate Director role will be responsible for all aspects of clinical trial management and oversight of trial teams. Relationships This position reports to the… more
- Merck & Co. (Durham, NC)
- …self-directed strong skill sets in planning / scheduling, and time management .Experience with Quality Risk Management .Experience with Deviation ... in compliance with cGMP, regulations, and our Company's Quality Management System focusing on batch record review, process/aseptic observations, critical site… more
- Merck & Co. (Rahway, NJ)
- …and Combination Product current Good Manufacturing ruling (21CFR part 4), Device Risk Management (ISO 14971) and other worldwide regulations and requirements. ... of a combination product.Review and approve Design Control and Device Risk Management documentation for regulatory filings, clinical supply, development,… more
