- GRAIL (Durham, NC)
- …visit grail.com . As a key member of the Quality Leadership Team, the Director of Quality Audits will be responsible with overall leadership and ... Audit Program. + Responsible for technical development of personnel, leading others through audits and ensuring the quality of deliverables within their purview.… more
- Merck & Co. (Rahway, NJ)
- …(SME) - Associate Director , will report to the Animal Health Global Quality Compliance and Technical Lead.-- The responsibility of this position is across all ... and escalation of potential critical observations and compliance gapsAssist during USDA audits .Oversee quality and compliance activities within assigned area of… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …evolve, so does our challenge to find better and more innovative ways to improve their quality of life. We're changing lives for a living. Are you ready to make a ... difference? The Position The Director Medical Review oversees a team of Medical Reviewers...processing activities for adverse events (AEs) and associated product quality complaints (PQC) for US Operations (USO) post-marketed products… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …evolve, so does our challenge to find better and more innovative ways to improve their quality of life. We're changing lives for a living. Are you ready to make a ... through strategic vendor partnerships. Relationship This job reports to the Senior Director of the GxP Compliance & Technical Operations. This job will interact… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Job Summary: The Director of Data Management (DM) Reporting provides leadership in Data Management ... portfolio across drug programs. This role is responsible for ensuring the quality and timely delivery of programming deliverables, including integrated data review… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …evolve, so does our challenge to find better and more innovative ways to improve their quality of life. We're changing lives for a living. Are you ready to make a ... Compliance, Global Safety, and centralized teams (eg, Training and Documentation, Quality , Supplier and Contract Management and Digital Enablement). This role will… more
- Eisai, Inc (Nutley, NJ)
- …(including audit and inspection management, issue management, and oversight of the quality management system).Conduct complex audits of sites, vendors and ... internal process.Train junior auditors and participate in training audits .Contribute to the overall global clinical quality strategy and roadmap, and drive… more
- Insmed Incorporated (NJ)
- …and checkpoints for critical CDMOs and service providers.Lead or support Quality Agreements, risk assessments, audits , and vendor qualification activities ... Quality release/rejection and related processes.Support supplier and internal audits as necessary.Create and maintain Standard Operating Procedures relating to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Summary The Executive Director , Data Management (Head of Global Data Management) sets the vision, ... development of group members and also monitors trends in functional performance via quality , time, and cost indicators, and develops plans and leads the execution… more
- Insmed Incorporated (NJ)
- …and for the future of science, we're in. Are you?About the Role:The Associate Director , Quality Control will be responsible for leading and overseeing all ... Quality Control activities related to inhalation products, including both...provide QC-related documentation and responses during regulatory inspections and audits .Review and approve analytical method execution, instrument qualification records,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …across all Medical Affairs programs. This role involves deputizing for the Sr. Director , representing the Quality organization at senior levels. The Director ... plays a pivotal role in regulatory inspections, external audits , and high impact projects, fostering s culture of...of excellence and compliance and working toward building a quality mindset with Medical Affairs.Support the Sr. Director… more
- Insmed Incorporated (NJ)
- …in. Are you?About the Role:We are seeking a highly motivated and expert Executive Director , Internal Audit & SOX (ED, IA) to lead our internal audit function and ... policies and industry best practices, responsible for leading and managing internal audits , assessments and SOX 404 requirements. This position requires a proactive,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …global role that will cover signal activity across all DS regions. The Associate Director of the Signal Management Center of Excellence (CoE) will lead the daily ... as instruct teams on how to properly conduct high quality clinical evaluation of signals in the appropriate tool...in turn, act as key representer of DS in inspections/ audits (presentations of signal process, coordination of document requests)… more
- Insmed Incorporated (San Diego, CA)
- …and for the future of science, we're in. Are you?About the Role:The Associate Director , EDC Programming will lead and oversee EDC programming, and database build for ... and implementation of EDC systems to support clinical trials, ensuring data quality , compliance, and efficiency throughout the study lifecycle. The AD, EDC… more
- Sanofi (Morristown, NJ)
- Job Title: Director , Government Pricing Location: Morristown, NJ About the job Job Summary: The Director will lead the team responsible for ensuring timely and ... Average Selling Price ("ASP") and state price reporting requirements. The Director will interpret complex government pricing regulations and oversee system… more
- Sanofi (Cambridge, MA)
- …diagnostics/oncology and/or cell and gene therapy testing. Familiarity with laboratory audits and quality standards. Demonstrated ability to translate complex ... Job Title: Global Diagnostic and Scientific Affairs Director Location: Cambridge, MA About the Job We are seeking a highly motivated and scientifically skilled… more
- Merck & Co. (Rahway, NJ)
- …/ Function and ResponsibilityUnder the direction of the Client Audit Director ("CAD") and the Auditor-in-Charge ("AIC"), the Senior Specialist will:Participate in ... the execution of financial, operational, SOX 404 and IT audits , integrated audits and process audits...walkthroughs and sample testing) in line with the established quality standards and timelines.Collaborate with the audit team in… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Oversight Director . This job will interact with Patient Safety, Quality , Vendor and Contract Management, IT, Finance, Contract/Supplier of Customer Engagement ... find better and more innovative ways to improve their quality of life. We're changing lives for a living....regulated environment. Relationship This job reports to the Senior Director of the GxP Compliance & Technical Operations or… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …evolve, so does our challenge to find better and more innovative ways to improve their quality of life. We're changing lives for a living. Are you ready to make a ... the pharmaceutical or biotechnology industry. Relationship This job reports to the Senior Director of the GxP Compliance & Technical Operations or the Director ,… more
- Merck & Co. (Rahway, NJ)
- …positive impact on patients' lives.Under the direction of the Client Audit Director (CAD) and the Auditor-in-Charge (AIC), the Senior Specialist will:Participate in ... the execution of financial, operational, SOX 404 and IT audits , integrated audits and process audits...walkthroughs and sample testing) in line with the established quality standards and timelines.Collaborate with the audit team in… more
