- Merck & Co. (Millsboro, DE)
- …DNREC, etc.) of animal facilities and program reviews is required.PurposeThe Associate Director /Attending Veterinarian will report to the Site Quality Head/ ... Job DescriptionAssociate Director , Animal ServicesAbout the JobAnimal Health in Millsboro...company's Millsboro Animal Health facilities. This role is highly compliance -driven in accordance with State and Federal regulations as… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Co-Lead Deviation Investigations: Collaborate closely with the Quality Associate Director to co-lead the deviation investigations management system . Ensure ... in the treatment of multiple myeloma. Legend Biotech is seeking an Associate Director for Operations Compliance and Investigations Managementas part of the… more
- Creative Financial Staffing (Columbus, OH)
- …and externally. Position Responsibilities: Oversees all accounts, ledgers, and reporting systems ensuring compliance with appropriate GAAP standards and ... Senior Accounting Manager will ensure that the organization has the financial systems and procedures in place to support effective program implementation and ensure… more
- Merck & Co. (Rahway, NJ)
- …Training, and SOPs for all GxP automation systems .-Integration of control systems with MES, Quality , and Batch Reporting applications.Understand and adhere ... on automation within Biologics Process Research & Development (BPR&D).The Associate Director role-will provide process automation leadership within the BDC Pilot… more
- Catalent (Philadelphia, PA)
- … Quality function is to build, monitor, and sustain a robust and effective quality system that delivers reliable, high- quality products that meet all ... customer and regulatory agency requirements and expectations. Components of the quality system establish the requirements for and measure how Catalent complies… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …focusing on optimizing patient care and support. Relationships Reports to the Director of PSP Analytics and Ops Excellence. Key internal relationships include ... commercial insights and analytics, Privacy, Legal, Compliance , marketing, Market Access, Pricing Contracting Ops and Reimbursement, Finance, IT, etc. Other internal… more
- Insmed Incorporated (Bridgewater, NJ)
- …limited to, the following:Facilitate and maintain a risk-based and scientific-based quality system to support Good Pharmacovigilance Practice (GVP).Establish and ... as well as reviewing and tracking CAPAs.Broad knowledge of risk-based quality systems approaches consistent with post-marketing Good Pharmacovigilance Practices… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Executive Director for Cardiovascular & Metabolism (ED CVM) within US Medical Affairs (USMA) will lead the USMA field medical (FM) teams ... strategies.Co-chairs Regional Medical Affairs Team (RMAT) meeting with US Regional Director Medical Affairs (RDMA)Supervises the RMSD Team Leaders and coordinates… more
- Catalent (Harman, WV)
- …stakeholder satisfaction.Catalent is committed to a Patient First culture through excellence in quality and compliance , and to the safety of every patient, ... Senior Director , Supply Chain Position Summary: The Senior ...and financial costing. This includes the deployment of common systems , improved processes and advanced technology to drive continuous… more
- Merck & Co. (Rahway, NJ)
- …Sourcing Partners.Ensure appropriate and consistent application of SOPs, standards and quality and compliance measures.Engage with cross functional stakeholders ... statistical programming deliverables using global and TA standards and according to quality , compliance and timeliness requirements; expertise in SAS and… more
- Merck & Co. (Rahway, NJ)
- …available which is accountable for all EHS program execution and compliance at our Manufacturing Division's Global Biologics Operations manufacturing facilities ... and global business partners to drive prioritization of regulatory compliance , continuous performance improvement, and integration of EHS performance objectives… more
- Eisai, Inc (NJ)
- …and compliance with global and regional processes.Ensure contract tracking systems and databases updated with relevant information by the Outsourcing team in ... want to hear from you. Job Summary The Associate Director , Clinical Outsourcing, will oversee and lead and support...providers for Eisai's R&D functions. This role will ensure compliance with key processes and manage the outsourcing team.… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionWe are looking for a Senior Director to lead our Offensive Security Operations team (AKA Red Team), a group of highly skilled and experienced ... threat emulation services to our clients. As the Senior Director , you will be responsible for defining the vision,...Operations capabilities, as well as overseeing the delivery of high- quality and mission driven security assessments. You will also… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …within the GPT, by interacting with other GxP QA functions (GMP/ IMP QA, Audit Compliance , Quality Management System [QMS] QA, PV/MA Quality ) and ... Reviews of respective product profile to ensure appropriate management review of all quality and compliance related topics including the review of Key … more
- Eisai, Inc (Nutley, NJ)
- …maintains reporting and validation testing standards for the department, and monitors compliance with these standards.Oversee data quality management process for ... from you.JOB SUMMARY:As a member of the Data Analytics group, the Associate Director , Commercial Analytics is part of a high performing team that provides… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders.Summary The Executive Director , Global Clinical Operations Study Management Group Head has leadership and ... for ensuring the clinical trial portfolio and submissions are delivered to time, quality , and cost. The teams reporting into this role must ensure robust strategic… more
- Tris Pharma (Monmouth Junction, NJ)
- …success.We have an immediate opening in our Monmouth Junction, NJ facility for a Director , Drug Safety. The Director , Drug Safety is responsible for planning, ... cross-functionally with counterparts/teams in Clinical Development, Regulatory Affairs, Manufacturing, Quality , etc. to identify, evaluate and communicate safety observations.… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …marketing and the regulatory and legal aspects of digital marketing. Ensuring compliance with legal and defined quality requirements Identifies opportunities to ... as well as portfolio wide initiatives related to driving acquisition, conversion, compliance /persistence and loyalty. Serves as a lead and strategist for the… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …Practices (GEP), Good Automated Manufacturing Practices (GAMP) etc.Ability to evaluate automation systems from a compliance perspective and ensure adherence to ... Position Summary The Engineering Director is directly responsible for leading the Engineering...in the successful design, construction, and commissioning of facility systems , as well as all process and laboratory equipment.… more
- Eisai, Inc (Nutley, NJ)
- …incumbent is expected to be a team player, and an advocate for quality , compliance , professionalism, and core corporate values at Eisai. Essential Functions ... Neurology products, and will be responsible to deliver high quality and impactful models to ensure optimal patient access....Inc. participates in E-Verify. E-Verify is an Internet based system operated by the Department of Homeland Security in… more
