- Merck & Co. (Millsboro, DE)
- Job DescriptionAssociate Director , Animal ServicesAbout the JobAnimal Health in Millsboro Delaware seeks to add an Attending Veterinarian in the role of Associate ... Director .This position will have overall responsibility for oversight and...Federal regulatory agencies. Leadership for internal and external regulatory inspections (USDA, DEA, DNREC, etc.) of animal facilities and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …as other research areas centered around rare diseases and immune disorders.Summary The Director , Global eQMS Management QA GMP, reports to the Senior Director , ... including Deviation- Change Control- Product Quality Complaint- Product Recall- Audit/ Inspection - Vendor/Supplier Quality Management- Analytics and Quality Scorecards- Cross-Functional… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …employer including veterans and people with disabilities. Summary The Associate Director , External Data Management, is accountable for the end-to-end delivery of ... Ensure consistency of standard implementation across programs. Is accountable for inspection readiness of external data documentation filed/archived in Trial Master… more
- Insmed Incorporated (Bridgewater, NJ)
- …New York™, and Best Workplaces for Millennials™ lists.OverviewReporting to the Executive Director of Development Quality Assurance, the Senior Director of ... to support Good Pharmacovigilance Practice (GVP).Establish and maintain Pharmacovigilance inspection readiness in collaboration with DSPV subject matter expert (SME)… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …on tech transfers and site activities. Recommend remediations, CAPAs and provide inspection support as appropriate to mitigate risks or gaps at the manufacturing ... sites.- Conduct scouting activities and recommend CDMOs for clinical and launch site selection from Tech Mgmt. (mAb, Drug Substance, Drug Product, or New Modality) perspective. Support technical recommendations for future manufacturing sites and their… more
- Merck & Co. (Rahway, NJ)
- …member of the Medical Device Combination Products Quality QMS group, the Associate Director , will participate in and/or lead various initiatives in support of our ... aspect of our business processes, systems, and data. - The Associate Director will collaborate and interact with cross-functional and cross-divisional teams to… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to patient's rights and well-being and in support of successful Health Authority inspections and approvals. Lead in a proactive and strategic way and through ... with the supported GPTs including the quality risk assessments and inspection readiness components for the designated programs. Ensure proactive representation of… 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, ... safety data in pharmacovigilance and clinical trial databases Ensures audit and inspection readiness of Drug Safety team at all times; Ensures internal regulatory/PV… more
- Merck & Co. (Rahway, NJ)
- …in accordance with identified target dates.Review and/or approve regulatory permits, inspection outcomes and audit report findings to assure appropriate submission, ... impact, and/or action.Develops/oversees solutions and reports status readily to executive management.Anticipate, recognize and respond to changing internal and external trends, market conditions, regulatory legislation, etc., evaluate and integrate the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …RMP process and proactively manage the resource model and timelines- Support CoE Audit Inspection Plan:Manage and establish a GOMA CoE Audit Inspection Plan in ... partnership with QA and relevant stakeholders across functions, geographies and levels of the organizationEnsure proper end-to-end documentation focusing on operational effectiveness and efficiency by building and maintaining a repeatable and standardized… more
- Catalent (Harman, WV)
- Position Summary The Director , Quality Systems is responsible for the management and oversight of the core quality systems, including investigation/deviation ... CAPA tracking, change control, risk management, supplier quality, audits and inspections , raw materials release, and compiling, trending and reporting key quality… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …across multiple therapeutic areas and experience with regulatory submissions and inspections . Finally, this position has strong skills in continuous improvement, ... Analysis Plans, Clinical Study Reports).Actively participates in audits and inspections .Operational Efficiency / Continuous Improvement:Provides leadership within Data Management… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders.SummaryThe Senior Director of Clinical Operations will manage clinical operations staff to ensure ... ongoing collaboration and communication with internal stakeholders. Detailing The Senior Director will ensure a robust communication plan including status and timing… more
- Insmed Incorporated (Bridgewater, NJ)
- …New York™, and Best Workplaces for Millennials™ lists.OverviewReporting to the Executive Director Quality GMP Compliance, the Director , Quality Operations will ... etc.Act as company's representative during regulatory agencies and customer inspections .Supports the investigation of product and related CAPAs. Partner with… more
- Merck & Co. (North Wales, PA)
- …preparing for numerous potential launches of our medicines and vaccines. As Associate Director , Launch Excellence, you'll play an important role in preparing for and ... launch readiness across all strategic go-to-market launch components. Drive transparency, inspection , and adaptation of launch plan progress - ensuring tactical… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- Position Summary The Engineering Director is directly responsible for leading the Engineering team in the successful design, construction, and commissioning of ... Monitoring Controls, Optima Line and Ignition software implementation, AVI (Seidenader Inspection ), WLS Labeler, and Dividella Cartoner. Develop and maintain strong… more
- Insmed Incorporated (Bridgewater, NJ)
- …Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Executive Director (ED) will provide leadership to the DSPV Medical Safety Team. ... to the organizational planning, budget, and operations of DSPV.Ensures audit and inspection readiness of the function at all times.Prepares safety objectives, and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …StrategyAlign with the Head of Clinical Development Operations or Senior Director , Clinical Operations on plans for successful implementation of studies. Responsible ... study oversight and execution.Work with TMF Operations to ensure a state of inspection readiness for all TMFs and ensure quality expectations are met.When sitting on… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …assigned to individuals are current and up to date- Support regulatory inspection related activities as required- Support Head, Global strategy and operations to ... develop and plan the Global QA governance, communication strategies and manage the communication activities;- Distribute reports as necessary to the Global QA teams and ensure on time organization communication is cascaded to the teams for awareness.- Creates… more
- Dietz Property Group (Westerville, OH)
- …timely completion of service requests, performing preventative maintenance and unit inspections /rehabilitation as scheduled by the Community Director . JOB ... and unit rehabilitation as scheduled by the Maintenance Supervisor and/or Community Director . Complete required property and unit inspections and ensure any… more
