- Tris Pharma (Monmouth Junction, NJ)
- …knowledge or skills needed and/or licenses or certificates preferredCertified Quality Manager , Engineer or AuditorExperience with drug-device combination ... Located in Monmouth Junction, New Jersey, Tris has an immediate opening for a Manager , Quality Management Systems (QMS). Summary:The Manager , Quality … more
- Aequor (Bothell, WA)
- …Description: PURPOSE AND SCOPE OF POSITION: This position reports into the Quality Assurance department and is responsible for assisting with the implementation and ... Eight (8) or more years of relevant work experience in pharmaceutical quality operations, quality assurance, quality systems, and/or IT compliance role with… more
- Aequor (Thousand Oaks, CA)
- …. Associate will work from Remote US Location or in Thousand Oaks, CA. reporting to Manager or Sr . Manager Supply Chain within External Planning & Delivery ... 100% Remote. - manager prefers east coast. Candidate may need have...least Excel and remain self sufficient. is seeking a Sr . Associate Supply Chain to be a part of… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders. Summary The Sr Director GPM&L is accountable for delivering an integrated drug development ... to ensure delivery of projects within cost, time and quality requirements. As a leader in GPM&L this position...or organization.Mobilize others to gain alignment with the most Sr leaders and secure resources for the project.Accountable for… more
- Merck & Co. (Rahway, NJ)
- …of the SDLC, excellent communication and collaboration skills, and a focus on quality and customer satisfaction.The Release Manager is responsible for the ... business objectives.The SAP Platform team has an opening for a Release Manager with experience in coordinating and managing releases, knowledge of relevant tools,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …treatment of multiple myeloma. Legend Biotech is seeking an Operations Supervisor / Sr . Operations Supervisor (2nd shift) as part of the Technical Operations team ... help the team, in a manner consistent with safety policies, quality systems, and cGMP requirements. Support manufacturing investigations, create/revise operational… more
- Catalent (St. Petersburg, FL)
- …and metrics, including DRB (Deviation Review Board) presentation.Effective communication with Quality Assurance Supervisor and Manager regarding status of daily ... I. Department Overview: The Quality Assurance Department is responsible for providing leadership...in all applicable areas of the manufacturing operation. The Senior QA Specialist will assist in organizing and prioritizing… more
- Aequor (Thousand Oaks, CA)
- Remote role - need to work Pacific zone hours Manager would prefer candidates who are local to sit to support site operations once a week to once a month depending ... understood. ? Serve as the primary interface with Clinical Development, Quality , Biostatistics, Regulatory Affairs, Corporate Planning, and Operations to ensure… more
- Novo Nordisk Inc. (Durham, NC)
- …technology & processes in accordance with relevant project plans & timelines. Relationships Senior Manager , Quality Control - OFP. Essential Functions ... our employees to embark on life-changing careers, and the opportunity to help improve the quality of life for millions of people around the world. In NC, we operate… more
- Catalent (St. Petersburg, FL)
- Manager , QA (Product Development)Position SummaryThe Quality Assurance Department is responsible for providing Leadership and Quality Assurance Management ... and could include all or some aspects of the Quality function.The Product Development QA Manager provides...may oversee a staff from five to ten including Sr QA Technical Reviewers and QA Product Managers. Responsible… more
- Eisai, Inc (Nutley, NJ)
- …without regard to race, color, religion, gender, age, national origin, citizenship status, marital status, sexual orientation, gender identity, disability or veteran ... status. Similarly, considering the need for reasonable accommodations, Eisai prohibits discrimination against persons because of disability, including disabled veterans. Eisai Inc. participates in E-Verify. E-Verify is an Internet based system operated by the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …(FDA) regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines.The Senior Clinical Study Manager will have routine interaction ... US and abroad, governmental, academic, community and industry organizations.The Senior Clinical Study Manager role is primarily...for Operational Study Strategy. This position may require the Sr . CSM to take the role of both operational… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Clinical Data Science and Evidence (CDSE) Real World Evidence (RWE) team. Relationships The Senior Manager reports directly to a Senior Director within the ... evolve, so does our challenge to find better and more innovative ways to improve their quality of life. We're changing lives for a living. Are you ready to make a… more
- Aequor (Thousand Oaks, CA)
- …about 1 week a month - multiple short trips. In support of 's Quality Assurance program manages and oversees the operations of a specific area(s) of responsibility ... FUNCTIONS: 1.Responsible for hiring, training, supervising and performance management of staff. 2. May perform or oversee the following functions: a) Review and approve product MPsb) Approve process validation protocols and reports for Mfg. processes. c)… more
- Merck & Co. (North Wales, PA)
- Job DescriptionPosition Description: Senior Study Manager - Epidemiology OperationsSupport the Lead Epi Scientists by providing overall operational support for ... by internal/external labs and data transfer for biospecimen- based studiesParticipate in quality control assessments and ensure integrity of study data for reports… more
- Eisai, Inc (NJ)
- …If this is your profile, we want to hear from you. Job Summary The Senior Manager , Medical Writing will be the designated Lead Medical Writer for approximately ... system#LI-HC1#IND-123Eisai Salary Transparency Language:The base salary range for the Senior Manager , Medical Writing is from :126,300-165,800Under current… more
- Insmed Incorporated (Bridgewater, NJ)
- …monitoring remediation, and support in developing guidance documents and training. The Manager , US Compliance reports to the Senior Director, US ... - driving projects to completion independently with the utmost integrity.Produces high quality work with minimal oversight from Manager .Possesses a 'can-do'… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …direction and leadership for the investigations management system. Working closely with the Quality Senior Manager , this position will ensure alignment with ... organization, and driving continuous improvement initiatives to enhance investigation quality , timeliness, and productivity.Key Responsibilities Co-Lead Deviation Investigations: Collaborate… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …execution, quality control, and data derivation; collaborates closely with data manager to ensure high quality data. Work closely with internal statistical ... with internal programming colleagues in completing the deliverables with high quality according to timelines, and provide recommendations to improve process.-… more
- Merck & Co. (North Wales, PA)
- …related study materials (eg, ICF documents/amendments); Partners with the Study Manager on study deliverables.Ensuring CRF design supports data collection in ... Data Management/Programming.Collaborating cross-functionally to monitor clinical data to ensure quality , completeness, and integrity of trial conduct.Providing tactical/scientific mentorship… more
