- Merck & Co. (Durham, NC)
- …in the network of life-saving medicines and vaccines. - The Associate Director, Quality Systems and Compliance provides expertise in the coordination of ... during critical processing and manufacturing. FUNCTIONAL EXPERTISE: The Associate Director, Quality Systems and Compliance will be responsible for comprehensive… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …walk-through audits of NNUSBPI Manufacturing facilities Releases product based on Quality Assurance record review and approval by Manager , Quality ... experience in a pharmaceutical or biotechnology company with one (1) year direct Quality Assurance experience Knowledge, Skills, and Abilities: Ability to work… more
- Novo Nordisk Inc. (West Lebanon, IN)
- … compliance with specifications and procedures Releases product based on Quality Assurance record review and approval by QA Manager Performs regular ... EMEA or a leading international regulatory agency preferred As applicable, experience with Quality Assurance oversight and support for all phases of Clinical and… more
- Catalent (St. Petersburg, FL)
- …and metrics, including DRB (Deviation Review Board) presentation.Effective communication with Quality Assurance Supervisor and Manager regarding status ... I. Department Overview: The Quality Assurance Department is responsible for... Supervisor and Manager on performance of QA Specialists.Responsible for actively identifying compliance enhancements/improvements… more
- Catalent (St. Petersburg, FL)
- Manager , QA (Product Development)Position SummaryThe Quality Assurance Department is responsible for providing Leadership and Quality Assurance ... and could include all or some aspects of the Quality function.The Product Development QA Manager... Manager is responsible for the overall Quality Assurance review and approval of all… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …the candidate have experience working in an aseptic manufacturing facility, preferably in quality assurance , manufacturing compliance , clinical quality , ... Legend Biotech is seeking QA Manufacturing Excellence Manager as part of the Quality team...resolving complex scientific / technical problems Develops and evaluates quality processes and system standards to ensure compliance… more
- Aequor (Bothell, WA)
- …years of relevant work experience in pharmaceutical quality operations, quality assurance , quality systems, and/or IT compliance role with at least ... AND SCOPE OF POSITION: This position reports into the Quality Assurance department and is responsible for...and validation of automated systems is required. Experience with QA oversight of e-systems for GMP operations is required.… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Interact with legal and compliance as required. Proactively collaborate with other GxP quality representatives and act as QA point person for US and EU ... a quality culture within Global Medical Affairs Quality Assurance by providing study team support...and metrics. Support continuous process improvement, interpretation of regulations, quality and compliance with regulations and company… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …sharing of best practices and lessons learned. This role will also work with R&D Quality Assurance (R&D QA ) and the respective operational functions to ... in pharmaceutical or biotechnology in clinical trial operations or clinical quality assurance . required Experience Qualifications4 or More Years Strong… more
- Tris Pharma (Monmouth Junction, NJ)
- … Manager , Quality Management Systems (QMS) supports, oversees and manages the Quality Assurance ( QA ) Investigations and Product Quality Complaints ... knowledge or skills needed and/or licenses or certificates preferredCertified Quality Manager , Engineer or AuditorExperience with drug-device combination… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …investigator grants and pass-through costs.Provide oversight of the CRO to ensure compliance with Daiichi Sankyo's quality measures. Contribute toward the ... set forth by the Study team. The Clinical Study Manager role is primarily a tactical study delivery role,...functional integration and delivery of items (eCRF, EDC, IXRS, Quality Oversight Plan etc) per the study plan. Oversee… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Tech Unit Team culture. Service as a primary contact with Legal and Quality Assurance regarding records Retention and Training Coordination. Demonstration and ... trends, and variances to ensure acceptable business practices, procedures and compliance have been followed.- Contract Management/ Finance Liaison/ Internal Audit… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …well as other research areas centered around rare diseases and immune disorders.Summary The Manager / Senior Manager , Data Programmer is a member of the ... SDTM and collaborating with CROs and other vendors to ensure high quality deliverables to support drug development processes and global submissions as required… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …various contractors meets Global DX Computer System Validation requirements, global regulatory compliance , and global Quality expectations. Partner with global ... validation or qualification needed to achieve and maintain regulatory compliance regardless of service methodology (SaaS, On-Prem, Service Provider Outsourcing).… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …the oversight, performance, and management of CRO(s) and 3rd party vendors to ensure compliance with Daiichi Sankyo's quality measures and adherence to scope of ... and International Conference on Harmonization (ICH) guidelines.The Senior Clinical Study Manager will have routine interaction with key internal and external… more
- Aequor (Thousand Oaks, CA)
- …leadership, International Quality , Quality Control, Contract Manufacturing Quality , Regulatory, Process Development, Quality Assurance , and other ... Manager is requesting candidates college GPA in the...of product development? Knowledge of protein and small molecule quality , compliance and regulatory requirements? Knowledge of… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas (eg clinical research & development, clinical science, clinical quality assurance , project management) preferredStrong leadership, collaboration, ... to existing GCO procedural document packages.As needed, monitor 1) procedural compliance metrics to support inspection readiness activities, and 2) procedural… more
- Citizens (Johnston, RI)
- …fulfilling career with exciting new challenges and opportunities to stretch yourself. As the Compliance Manager , you will work to mitigate risk and assure that ... to you, personally and professionally! We are seeking a Compliance Manager to support all aspects of...oversight and advice to applicable business lines and performing quality assurance and control reviews of small… more
- Pine Street Inn (Jamaica Plain, MA)
- Senior Housing Compliance Manager Department: Supportive Housing - Property Management Office: 82 Green Street Location: Jamaica Plain, MA Position Type: ... Street, Jamaica Plain, MA JOB DESCRIPTION: SUMMARY OF POSITION: The Senior Housing Compliance Manager for Pine Street Inn, Inc. provides oversight of Subsidy… more
- Magellan Health Services (San Diego, CA)
- … deficiencies. Submits reports to the Quality Improvement Committee (QIC), Compliance Committee, Business Unit Manager , and the corporate Compliance ... Retirement Income Security Act of 1974 (ERISA), National Committee for Quality Assurance (NCQA), Utilization Review Accreditation Commission (URAC), federal… more
