- Tris Pharma (Monmouth Junction, NJ)
- …success. Located in Monmouth Junction, New Jersey, Tris has an immediate opening for a Manager , Quality Management Systems (QMS). Summary:The Manager , ... standards and objectivesOversee and manage the maintenance and tracking of Quality Systems including, but not limited to Investigations/OOS/OOT/Lab Event,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …promise of an immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking Quality Systems Lead role as part of the Quality Operations team ... based in Raritan, New Jersey. Role Overview The Quality Systems Lead role is an exempt level position with responsibilities for supporting the quality … more
- Catalent (Philadelphia, PA)
- …the Manager , Training Program and the Training Lead.Cross train with Quality Systems team by supporting activities of the Manager , Quality Systems ... As a Training Coordinator, you will support the Training Program and Quality Systems . This position will assist in the development and maintenance of new… more
- Catalent (San Diego, CA)
- …5 years' experience in QA/Regulatory Affairs areas with progressive responsibilities for quality metrics, quality systems , deviations, investigations, CAPAs ... Senior Manager , Quality AssurancePosition Summary:Catalent Pharma in...forms.Must have a demonstrable record of implementing and maintaining quality systems ; laying out a strategic plan… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition Description: Associate Clinical Research Manager (aCRM) - Oncology With support of other Clinical Research Manager 's (CRMs) and/or ... with-ICH/GCP and country regulations, Our Company policies and procedures, quality standards and-adverse event reporting requirements internally and externally.The… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …simultaneously Perform tasks in a manner consistent with the safety policies, quality systems , and cGMP requirements. Drive continuous improvement Other duties ... of multiple myeloma. Legend Biotech is seeking QA Manufacturing Excellence Manager as part of the Quality team based in Raritan, NJ. Role Overview The QA… more
- Catalent (St. Petersburg, FL)
- …productionProvide support to internal, client, and regulatory audits.Engage in monitoring quality systems to maintain awareness and audit/inspection readiness at ... for their clients within the Catalent St. Petersburg site. The QA Product Manager is responsible for the overall Quality Assurance review and approval… more
- Eisai, Inc (NJ)
- …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 3-4 Programs. ... As the Lead Medical Writer, the incumbent ensures timely completion, accuracy and quality of all clinical and submission documentation across all aspects of the… more
- Aequor (Thousand Oaks, CA)
- …experience. Preferred: DAM (digital asset management) CMS (content management systems ), and artificial intelligence experience. Large organization experience. The ... Project Manager will be accountable for managing one or more...to delivery specified requirements. This includes ensuring timely and quality delivery and comms around innovative content pilots designed… more
- Eisai, Inc (Nutley, NJ)
- …your profile, we want to hear from you. Job Summary The Senior Manager , Translational Science Biostatistics will be expected to work independently with minimal ... TLG shells and specifications of variable derivation.Monitoring - develops Study Quality Surveillance Plan and monitors study conduct to proactively address issues… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …opportunity employer including veterans and people with disabilities. Summary The Manager External Data Management, is accountable for an end-to-end delivery of ... on behalf of Daiichi Sankyo. This position also ensures quality delivery of all 3rd party data from diverse...the collection of diverse external data types.Advises Study Data Manager on complex vendor management issues and provides guidance… more
- Lundbeck (New York, NY)
- …the way in creating positive customer experiences!As a Biopharmaceutical Area Sales Manager (BASM) you will be responsible for leading, developing, and managing a ... Others Achieves business objectives and sales results by observing Account Manager interactions with target customers, extended treatment team members, ancillary… more
- Catalent (St. Petersburg, FL)
- …within at Catalent's St. Petersburg site. The Department has the responsibility for Quality aspects related to Quality Systems , Finished Product Batch ... QA Product Manager Position SummaryThe QA Product Manager is responsible for providing Leadership and Quality Assurance Management support… more
- Novo Nordisk Inc. (Durham, NC)
- …duties & QA presence & process confirmation on shop floor. Relationships Manager , Quality Assurance. Essential Functions Ensures site compliance with ... the Batch Review Processes required Understanding of validation preferred Understanding of quality management systems required Understanding of quality … more
- Merck & Co. (Durham, NC)
- Job DescriptionThe role of Operations Manager at our Company's Durham facility is a manufacturing leadership role. The individual in this role must provide ... management). Additionally, they must become proficient in the use of manufacturing systems and knowledgeable of site procedures in order to resolve process/equipment… more
- Merck & Co. (Rahway, NJ)
- …with ICH/GCP and country regulations, our company's policies and procedures, quality standards and adverse event reporting requirements internally and externally.Our ... at study closeout. Oversees FCPA, DPS/OFAC, and maintenance of financial systems . Financial forecasting in conjunction with Sr.COM /other roles.Executes and oversees… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …consistency and quality of data across key Daiichi Sankyo regulatory systems . This includes defining regulatory data standards, data quality rules and ... areas centered around rare diseases and immune disorders. Summary The Regulatory Data Manager will be a key member of the Global Regulatory Affairs (GRA) Process… more
- Merck & Co. (Durham, NC)
- Job DescriptionOur Quality Assurance group ensures all materials inside our products and the products themselves are manufactured, tested, and distributed in ... alignment with our high standards of quality . Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers, we create an… more
- Novo Nordisk Inc. (Durham, NC)
- …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 ... coordination with IT, metrology & other key stakeholders to ensure the right quality , cost & timely completion of all deliverables. Relationships Manager .… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …DX Computer System Validation (CSV) projects within Daiichi Sankyo, for Computerized Systems supporting GxP and Non-GxP activities, assuring that these systems ... Validation Lead support for Daiichi Sankyo GxP and Non-GxP computer systems implementations in partnership with Global DX, and QA-CSV/eCompliance team members… more
