- Insmed Incorporated (San Diego, CA)
- …of continuous learning, cross-training, and operational excellence.In partnership with Regulatory Operations , and/or third-party service providers, ensure high ... Women™, Best Workplaces for Millennials™, and Best Medium Workplaces™ lists.OverviewThe Director, Regulatory Affairs will serve as the regulatory leader on… more
- Merck & Co. (Rahway, NJ)
- …for CMC. Strong understanding of integration and partnering with Quality, Regulatory , Operations , Non-clinical, Clinical, and other functional areas. ... packaging, compatibility characterization for processing and administration, and supporting regulatory filings. Collaborate with key stakeholders across the organizations… more
- Eisai, Inc (Nutley, NJ)
- …years significant clinical pharmaceutical experience (ie, clinical development or operations , regulatory compliance).Substantial experience in Clinical Quality ... area.Anticipate immediate and long-term risks to quality support for overall operations continuity and propose/ implement pre-emptive actions through engagement with… more
- Merck & Co. (Durham, NC)
- …network: build and maintain strong and trusting relationships with site technical operations , quality, regulatory , stability, and other stakeholders to ensure ... will partner with the team Technical Product Leader as well as site Technical Operations and other key members of the Technical Product Council to implement the… more
- Merck & Co. (Durham, NC)
- …network: build and maintain strong and trusting relationships with site technical operations , quality, regulatory , stability, and other stakeholders to ensure ... will partner with the team Technical Product Leader as well as site Technical Operations and other key members of the Technical Product Council to implement the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …working closely with our QA organization to implement ongoing learnings from regulatory inspections.Engage and motivate Clinical Operations employees to execute ... around rare diseases and immune disorders. SummaryThe Senior Director of Clinical Operations will manage clinical operations staff to ensure the effective… more
- Merck & Co. (Rahway, NJ)
- …acumen such as product knowledge, healthcare systems, payors and customers, regulatory , business operations and reputational risks while working intimately ... with our global business partners.-In addition, individuals will use data analytics to gain insights into business practices and the execution of the company's strategy. Individuals will be based in the global headquarters in Rahway, NJ.Opportunity to Innovate… more
- Merck & Co. (Rahway, NJ)
- …the efficient management of data across the organization, including compliance with regulatory standards, and the optimization of laboratory operations and ... and inventory strategies into actionable plans and benefits DD&T lab operations .Collaborate across DD&T sub-functions, regulatory affairs, quality assurance,… more
- Merck & Co. (Rahway, NJ)
- …readiness as well as preparing for, management and follow up of regulatory inspections.Operational Quality Management:The Clinical Quality Operations Manager is ... Job DescriptionIn partnership with the Clinical Quality Operations Lead (CQOL and Head of CQO, the...Preparation and Management:The CQOM is responsible for maintaining current regulatory inspection knowledge as it relates to Good Clinical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and cultures. Additionally, he/she will possess advanced knowledge of clinical operations and relevant regulatory requirements. The individual will have ... therapeutic areas and is capable of leading DM activities to support regulatory submissions and inspections. Finally, this position has advanced skills in continuous… more
- Merck & Co. (Millsboro, DE)
- …functional partners.Quality- and compliance-focused with practical experience supporting regulatory inspections, validations and cGMP operations .Required ... problem solving.Provide subject matter expertise for product release, aseptic operations , formulation and fill/finish activities.Ensure compliance with corporate and… more
- Merck & Co. (Durham, NC)
- …a night shift position on a 12.5 hour shift rotation (2-2-3). -Our Manufacturing Operations teams are the people that make our products. We work in the manufacturing ... vaccine manufacturing to help eradicate HPV-related cancers and diseases. Members of the Operations team in this new and exciting facility will have the unique… more
- The Pivot Group (Coopersville, MI)
- …advancement. Required Skills: *Process Improvement *Six Sigma *Offers *Search *Business Operations * Regulatory Compliance *Daily Operations * Operations ... Description: Are you a dynamic leader with a passion for optimizing business operations and driving organizational success? The Pivot Group Network is dedicated to… more
- Merck & Co. (Durham, NC)
- … Support, Process Optimization, Production Scheduling, Production Support, Regulatory Compliance {+ 4 more}-Preferred Skills:Job Posting End Date:09/25/2025 ... Job DescriptionOur Manufacturing Operations teams are the people that make our...established safety procedures in accordance with OSHA and other regulatory agencies- Identifies and addresses compliance, environmental, safety, and… more
- Merck & Co. (Durham, NC)
- Job DescriptionOur Manufacturing Operations teams are the people that make therapies for our patients. We work in the manufacturing plants with a "Safety First, ... but are not limited to; Project Support Supports project team as operations expert through start-up, commissioning, qualification through licensure and ramp up of… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …project management in cross-functional drug development teams or clinical, regulatory , pharmaceutical sciences/technical operations in the biopharmaceutical ... Biotech is seeking Senior Project Manager, PMO as part of the Technical Operations team based in Raritan, NJ. Role OverviewThis position will be responsible for… more
- Merck & Co. (Durham, NC)
- …a night shift position on a 12.5 hour shift rotation (2-2-3). -Our Manufacturing Operations teams are the people that make our products. We work in the manufacturing ... vaccine manufacturing to help eradicate HPV-related cancers and diseases. Members of the Operations team in this new and exciting facility will have the unique… more
- Merck & Co. (Rahway, NJ)
- …sites, packaging & device development and technology teams, supply chain, operations , quality, analytical, regulatory , and project leaders. The successful ... Platform Technical LeadershipReporting into the Executive Director Packaging Technical Operations the Director Packaging and Assembly Platform Technical Leadership… more
- Merck & Co. (Durham, NC)
- …shift and night shift positions, 12.5 hour rotation (2-2-3). -The role of Operations Manager at our Company's Durham drug substance manufacturing facility is a ... this role must provide direction, coaching, and technical expertise to operations personnel responsible for the manufacturing processes. This individual must… more
- Merck & Co. (Rahway, NJ)
- …and manufacturing sites, device development and technology teams, supply chain, operations , quality, analytical, regulatory , and project leaders. The successful ... drug products such as prefilled syringes and autoinjectors.-The Packaging Technical Operations organization aims to be an industry leader in problem-solving,… more
