- Insmed Incorporated (San Diego, CA)
- …for Women™, Best Workplaces for Millennials™, and Best Medium Workplaces™ lists.OverviewThe Senior Manager has responsibility for the QA oversight of ... Technical Operations and CDMOs, associated vendors and contracted laboratories.Apply Quality Risk Management for key processes and systems. Identify improvement… more
- Merck & Co. (Durham, NC)
- …of technical and operational problems through collaboration with peers.Applies appropriate risk management while adhering to cGMP requirements.Makes decisions ... qualification/validation activities supporting the vaccine expansion facility.Primary Responsibilities:The Quality Senior Specialist will be responsible for comprehensive management… 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 ... Job DescriptionPosition Description: Senior Specialist, Quality Assurance Our Company will construct...in compliance with cGMP, regulations, and our Company's Quality Management System. Supporting areas such as Design, Commissioning, Qualification… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines. The Senior Clinical Study Manager will have routine interaction with ... in the US and abroad, governmental, academic, community and industry organizations.The Senior Clinical Study Manager role is primarily a tactical study… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …its application to drug development required to deliver time, cost, quality, and risk management to teams.Demonstrated results in creating and managing complex ... in the treatment of multiple myeloma.Legend Biotech is seeking Senior Project Manager , PMO as part of...position will be responsible for providing operational excellence project management support to the cGMP Clinical and Commercial Cell… more
- Merck & Co. (Rahway, NJ)
- …activities such as site readiness, audits, inspections, and CAPAs. Support quality risk management activities as facilitator, project lead and/or quality subject ... Job Description Job Description: The Rahway based Senior Specialist, Global Development Quality Operations - API, is responsible for independent review and approval… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Update Reports (DSURs), periodic SUSAR reports, Periodic Safety Update Reports (PSURs) and Risk Management Plans (RMPs) according to implementation plans or as ... management responsibility of Director/Associate Director Global Safety Lead, Senior Global Safety Scientist(s)/Global Safety Scientist(s) within the Safety… more
- Novo Nordisk Inc. (Durham, NC)
- … management Operate within compliance with a Quality Mindset that focuses on risk management & mitigation Implement effective Change Management Support ... and help us make what matters. The Position Seeking level II or Sr level Application Engineers with Pas-X experience. This position is responsible for ensuring… 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 ... Located in Monmouth Junction, New Jersey, Tris has an immediate opening for a Manager , Quality Management Systems (QMS). Summary:The Manager , Quality … more
- Genmab (Plainsboro, NJ)
- …an innovative and growing organization? At Genmab, we're seeking a Senior Director, Strategic Planning & Effectiveness to drive cross-functional communication, ... This role will serve as Chief of Staff to the US, General Manager focusing on evolving operating models, building new capabilities, optimizing resources, and leading… more
- Novo Nordisk Inc. (Los Angeles, CA)
- … identification and mitigation planning for assigned clinical trial sites, leveraging Risk Based Quality Management (RBQM) principles and tools; executes ... scientific integrity; regulatory and process compliance) for monitoring and site management activities. Takes ownership to deliver upon near-term North America… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and functional team members.Maintains global integrated project plans, project timelines, risk management plans and communication plans. Resolves complex ... of these objectives. This position will report to the Sr Director, Group Leader, GPM&L or the Executive Director,...proposals and stage gate proposals for formal presentation to senior management .Is comfortable working independently within a… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …across various product teams and global manufacturing sitesProvide updates to Senior Management on site validation status activitiesProvide validation training ... validation, computer system validation and calibrationPerform functional and process risk assessments in conjunction with Quality and Manufacturing subject matter… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …linking data, and maintaining applicable procedures Core roles include communication, compliance, risk management , and use of current technology The role ... onsite based role 5 days per week Monday-Friday. Relationships Reports to: Sr . Manager Facilities, Engineering, and Metrology Essential Functions Engineering… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …the system administrator and quality system interface for Siemens Building Management System (BMS) and Environmental Monitoring System (EMS). Relationships Reports ... to: Manager of Automation Engineering Essential Functions Lead, plan, organize...users Develop and implement project(s) under the support of Sr . Engineer or external consultants as appropriate to maintain… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …helping to develop and deliver processes, training, procurement technology and knowledge management tools. Closely partners with senior Business stakeholders to ... all Strategic Sourcing efforts through to final contract, including project management , supply analysis, supplier identification, risk mitigation, sourcing… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …achievement of Company and/or departmental expectations and goals as identified by senior management .Responsibilities- Acts as a brand attorney and lead legal ... the Company. [Specific assignments to be determined by direct manager of the role.]- Creates, implements, and presents training...current developments in several key legal areas and provides Senior Management and other business leaders with… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …investments, companion diagnostic, academic research organization, and acquisition deals. Advises senior management on legal and regulatory issues, leads complex ... as assigned. [Specific assignment to be determined by direct manager of the role. Global Human Resources (including Benefits)...current developments in assigned key legal areas and provides Senior Management and other business leaders with… more
- Fidelity Investments (Boston, MA)
- …the individual will be charged with working across the team to provide valuable risk management insight to our business partners, including performing risk ... on risk standards and industry best practicesThe TeamFidelity Enterprise Risk Management is a global organization dedicated to protecting Fidelity's… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …listening to, identifying and addressing stakeholder needs Understands and applies risk management practices: Supports the implementation of security policies, ... project managers. This role will interface routinely with key stakeholders including GSO management , senior security operations personnel, as well as third party… more
