- Merck & Co. (Rahway, NJ)
- … of GMP Compliance will report to the head of the Global Quality Compliance Support organization.- The responsibility of this position crosses all Human & ... and research services to global QMS topic owners and site quality experts to assess the compliance impact of potential updates to our company's policies and… more
- Merck & Co. (Rahway, NJ)
- …and tackle challenges, balancing effective operations with transformative initiatives.- The Associate Director , Quality System & Compliance will support to ... Functions & Responsibility As a member of the Device Quality & Regulatory QMS group, the Associate Director...capabilities that touch every aspect of our business processes, systems , and data.The Associate Director will collaborate… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … quality standards are met.Proactively assess and address operational gaps related to quality systems and compliance , fostering a culture of sustainable ... R&D & PV QA) ensures high standards of data quality and compliance within Global R&D &...for GxP systems .ResponsibilitiesLeadership and Strategic DirectionThe Sr. Director , Data Quality and Integrity is essential… more
- Twist BioScience (South San Francisco, CA)
- …MES professionals, primarily software developers, who work in concert with Manufacturing Operations, Quality Assurance, and R&D. The Director will serve as the ... Director /Sr. Director , Manufacturing Execution System (MES)...and data visualization capabilities to support operational decision-making and quality reviews. Compliance & Validation: Ensure our custom… more
- Eisai, Inc (Nutley, NJ)
- …out routine, complex and for-cause audits Knowledge of data integrity controls and systems quality for clinical area Strong analytical skills and report writing ... is your profile, we want to hear from you. Director , Clinical Quality Assurance The Director...Good Clinical Practice (GCP) oversight, and for assuring the compliance of projects, products and programs with Eisai's Standard… more
- Merck & Co. (Rahway, NJ)
- …design verification testing, and process validation, with a strong understanding of quality management systems and regulatory compliance . Exceptional project ... focus on autoinjectors, prefilled syringes, and other drug delivery systems . The Associate Director will collaborate with...launch in alignment with the company's business goals, and quality and regulatory compliance . Essential Duties and… more
- Genmab (NJ)
- …a fit? Then we would love to have you join us!The RoleThe Associate Director , External Data Quality Management, is a strategic leadership role within Clinical ... protocol deviations and is a key driver for inspection readiness, regulatory compliance , and successful data submissions.The Associate Director will lead… more
- Merck & Co. (Durham, NC)
- …teams to collaboratively address issues and achieve milestones. Maintain continuous focus on quality and safety compliance and unflinching focus on the customer. ... Lyophilization, and Filling) and cross-functional teams (ie Tech Ops, Maintenance, Quality , Automation, and Operations) to ensure a successful Validation support of… more
- Merck & Co. (Millsboro, DE)
- …(USDA, DEA, DNREC, etc.) of animal facilities and program reviews is required.PurposeThis Associate Director will report to the Site Quality Head/ Director of ... Job DescriptionOur company seeks to add an Associate Director . Veterinarian Services at our Millsboro, Delaware location. This position will have overall… more
- Merck & Co. (Durham, NC)
- …training to mechanics and other maintenance personnel.Interface with safety, production, and quality groups to ensure facility operations and systems comply with ... and implementation of preventative and predictive maintenance programs to assure compliance with quality , regulatory, and reliability requirements and… more
- Merck & Co. (Rahway, NJ)
- …results, remove barriers on portfolio or scientific prioritiesEvaluate and maintain appropriate quality systems and IT infrastructure for QP2 to support emerging ... drive pipeline impact and lead a talented group of pharmacometricians.This Senior Director is expected to be an experienced pharmacometrician with a strong,… 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
- Eisai, Inc (Raleigh, NC)
- …more complex with the launch of biologic products and hhceco initiatives, the Director will oversee Global Logistics and Import/Export compliance for commercial, ... more complex with the launch of biologic products and hhceco initiatives, the Director will oversee Global Logistics and Import/Export compliance for commercial,… more
- Eisai, Inc (Exton, PA)
- …close-out of documentation, manufacture of DS/ADI materials, and suite change-over ensuring compliance to relevant regulations. The Associate Director is also ... profile, we want to hear from you. The Associate Director of Biologics Operations Upstream and Downstream is responsible...with other Development groups as well as with Facilities, Quality Assurance, Quality Control, Regulatory, and CMC… more
- Repligen (Clifton Park, NY)
- …will play a key role in delivering the site expansion programs, implementing quality management systems and maintaining ISO certification. The individual will ... functions and have personal development plans.Ensure that the operation is in compliance with all aspects of Repligen's IS09001 Quality Management Responsible… more
- Merck & Co. (Rahway, NJ)
- …Cell Culture, Manufacturing Quality Control, Manufacturing Scale-Up, Manufacturing Systems , Regulatory Compliance {+ 2 more}-Preferred Skills:Job Posting End ... with a passion for biologics? We're looking for a dynamic and visionary- Director , Drug Substance Leader-to drive innovation and excellence across our Biologics… more
- Merck & Co. (Durham, NC)
- …Drug Delivery Systems and Devices within our Manufacturing Division (Associate Director ).-This role serves as a Virtual Plant Manager - responsible for leading a ... Compliance , Supply, Continuous Improvement, and Cost Management.--The Associate Director , External Manufacturing Operations will also assist in commercialization… more
- Merck & Co. (Rahway, NJ)
- …cross-functional teams.-Ensures project results meet requirements regarding technical quality , reliability, schedule, and cost.Monitors performance and recommends ... accurate information and status updates to project sponsors and management.Champion compliance and safety; promote a culture of diversity, inclusion, and… more
- Merck & Co. (Rahway, NJ)
- …Manufacturing Quality Control, Manufacturing Scale-Up, Manufacturing Systems , Regulatory Compliance , Results-Oriented, Technology Transfer-Preferred ... enhance data monitoring capabilities, and drive excellence in safety, compliance , supply, and productivity.Global Impact:Collaborate with colleagues across the US… more
- Merck & Co. (Rahway, NJ)
- …a lead GCS Planning program representative) such as clinical development, regulatory, quality and other supply chain areas to negotiate timelines,- strategies and ... the efficiency, accuracy, and effectiveness of clinical supply planning processes and systems . - Stay updated on industry trends, regulations, and best practices… more
