- Merck & Co. (Millsboro, DE)
- …performs process document audits for accuracy and completeness and works in a team environment to ensure timely review and documentation is Right First Time. The ... manufactured. The Senior Quality Specialist performs job functions within a team environment. Primary Responsibilities - Provides direct Quality support for… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking QA Investigations Lead III as part of the Quality team based in Raritan, NJ. ... Role OverviewThe QA Investigations Lead is responsible for providing quality oversight over the production of a personalized cell therapy to support both clinical… more
- Merck & Co. (Rahway, NJ)
- …R5-equivalent - About the role We are hiring a Senior Product Manager to lead strategic development of our Integrated Printing and Plastic Manufacturing system - a ... production execution, quality, and fulfillment. Your leadership will reduce waste, shorten lead times, lower TCO, and enable new commercial models for custom and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …of information and actions Ensure inspection readiness and support audits/ inspection as required Assist Patient Safety team projects as required ... Management, facilitating communication and addressing escalations to enhance overall team performance Provide mentorship and coaching to Technical Complaint… more
- BioAgilytix (Durham, NC)
- …the technical heavy lifting yourself while laying out the roadmap for a future team .Just as important, you'll own the last mile: turning those clean, validated data ... data sets to support the rollout of predictive analytics as the team grows.Independently create data visualizations and dashboards using tools like Power BI… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Continuous Improvement: Lead effective communication efforts within the Medical Affairs team , ensuring collaboration with other GxP QA functions (eg, GMP/IMP QA, ... Lead lessons learned efforts based on audit findings, inspection results, regulatory intelligence, effectiveness checks, and process improvements, ensuring… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …myeloma.Legend Biotech is seeking Head of Compliance as part of the Global Quality team based in Raritan, NJ. Role OverviewThe Head of Compliance will be responsible ... supporting both clinical and commercial sites. This individual will be a key leader in the Global Quality organization and a champion for quality principles and… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionAre you enthusiastic and driven to create and lead execution of design verification testing strategies for innovative combination products?Join our ... company's Device Product & Process Development (DPPD) Team , which focuses on the design, development, and commercialization of novel biologic/drug/vaccine-device… more
- Merck & Co. (Rahway, NJ)
- …and microbiological release of pipeline products.- The director will provide guidance, lead activities, and strengthen a team of microbiologists whose roles ... Job Description Job Description: Our Research and Development Division's microbiology team is seeking a Director for the Rahway NJ GMP microbiology operations.- The… more
- ValSource, Inc. (Worcester, MA)
- …standards are upheld. Lead and oversee Execution phase for the Process Team with CQV team , ensuring thorough testing of all requirements and demonstration ... to act in the best interest of the client. Lead the project through an offsite design effort (at...Coordinate succinctly and effectively with the management and reporting team to drive clear and timely decision making. Manage… more
- Merck & Co. (Rahway, NJ)
- …Director, will report to the Animal Health Global Quality Compliance and Technical Lead .-- The responsibility of this position is across all Animal Health operating ... to compliance standards established in 9CFR and enforced by USDA-APHIS-CVB Inspection and Compliance (IC), and Policy, Licensing and Evaluation (PEL).Develop and… more
- Merck & Co. (Rahway, NJ)
- …In this role, the Director of the Raw Materials and Medical Devices will lead a team of approximately 10 specialists and scientists supporting excipients, ... Small Molecule Analytical Research and Development (SMAR&D) GxP Operations team has an opening for a Director based in...in the laboratories, and for maintaining a state of inspection readiness at all times. The Director should be… more
- Repligen (Clifton Park, NY)
- …stringent company, industry, and GMP standards. Successful performance at this level can lead to progression to a Sr. Packaging .This position is for a Packaging ... company, industry, and GMP standards. Successful performance at this level can lead to progression to a Sr. Packaging Technician.Third shift Operators receive a… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …myeloma.Legend Biotech is seeking AD, Site Supply Chain as part of the Supply Chain team based in Raritan, NJ. Role OverviewThe Site Supply Chain Lead will be ... part of the Manufacturing Technical Operations team responsible for leading Supply Chain planning, inclusive of Production Planning & Scheduling, Materials Planning,… more
- Eisai, Inc (Nutley, NJ)
- …of the global Clinical Quality Assurance (CQA) strategy including audit and inspection management, issue management and oversight of the Quality management system. ... (CQA) strategy for the country/region in scope (including audit and inspection management, issue management, and oversight of the quality management system).Conduct… more
- Aequor (Thousand Oaks, CA)
- …you? Do you love to design and streamline processes within a hard-working team ? If you have a passion for streamlined, user-friendly Quality Management System ... GCO). In this vital role you will support the quality management system team to provide proactive compliance oversight to processes, functional areas and partner… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …process and SOPs. The Director will ensure the Senior Director, Clinical Operations (Asset Lead ) is fully informed of the overall portfolio status and that any risks ... The Director can be an extension to the Asset Lead when needed and serve as an SME (Subject...Joint Operating Committee. Ensure their direct reports and operations team in their assets have proper oversight plans in… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …with Data Operations leadership, asset leads, DM staff, and cross-functional team lead regarding goals, expectations, timelines, overall status, risks, ... experience, the ability to manage and coach people, and the capability to lead multiple projects concurrently are crucial for this role. Advanced knowledge of Data… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Oversight Lead and manage the Medical Review Case Processing team , fostering a culture of accountability, collaboration, and continuous improvement Provide ... difference? The Position The Director Medical Review oversees a team of Medical Reviewers responsible for Medical Assessment of...& Retrospective Quality Review of cases Regulatory Intel & Inspection Readiness Maintains up to date knowledge of the… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …across departments in relation to department objectives. Essential Functions Leadership & Oversight Lead and manage the global Case Processing team , fostering a ... Vendor leadership and hub leadership teams. Works closely patient safety leadership team members in Data Acquisition, Medical Review, and other case management… more
