- Tris Pharma (Monmouth Junction, NJ)
- …knowledge or skills needed and/or licenses or certificates preferredCertified Quality Manager , Engineer or AuditorExperience with drug-device combination ... in Monmouth Junction, New Jersey, Tris has an immediate opening for a Manager , Quality Management Systems (QMS). Summary:The Manager , Quality Management… more
- Merck & Co. (Durham, NC)
- …grasping pushing and pullingAbility to travel WORKING RELATIONSHIPS: Reports to Quality Manager Interacts with employees within own department Frequent ... Job DescriptionOur Quality Assurance group ensures every single material inside...and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements.- Partnering across our… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …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...an exempt level position with responsibilities for supporting the quality systems processes within a cell therapy manufacturing facility… more
- Novo Nordisk Inc. (Durham, NC)
- …duties and QA presence & process confirmation on shop floor. Relationships Manager , Quality Assurance. Essential Functions Ensures site compliance with ... 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
- Novo Nordisk Inc. (West Lebanon, IN)
- …Performs walk-through audits of NNUSBPI Manufacturing facilities Releases product based on Quality Assurance record review and approval by Manager , Quality ... certify compliance with specifications and procedures Works closely with Manufacturing and Quality Control to resolve open issues resulting from record reviews, walk… more
- Eisai, Inc (Exton, PA)
- …profile, we want to hear from you. Essential Functions Develop and manage quality system in support of combination products/medical devices for Eisai Americas. 60% ... Provide Quality "Person in Plant" support for products manufactured by...products manufactured by Eisai and contract facilities. 10% Provide quality support for Deviation Investigations and CAPA Management; Change… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders. SummarySupport the PVQA quality strategy and quality plan with specialty and the Oncology ... Business Unit globally; promote a quality culture within Global Medical Affairs Quality Assurance by providing study team support to uphold the ethical conduct… more
- Catalent (St. Petersburg, FL)
- Manager , QA (Product Development)Position SummaryThe Quality Assurance Department is responsible for providing Leadership and Quality Assurance Management ... Unit and could include all or some aspects of the Quality function.The Product Development QA Manager provides quality focused customer service, with the… more
- CHRISTUS Health (Tyler, TX)
- Reporting directly to the Manager of Clinical Quality , this position is the regional clinical resource rounding on practice sites to assess best practice in ... and with stakeholders from other ministries. Under the direction of the Manager of Clinical Quality , CCMS, this position leads quality initiatives to drive… more
- CHRISTUS Health (Tyler, TX)
- Description Summary: Reporting directly to the Manager of Clinical Quality , this position is the regional clinical resource rounding on practice sites to assess ... stakeholders from other ministries. Responsibilities: Under the direction of the Manager of Clinical Quality , CCMS, this position leads quality initiatives… more
- Novo Nordisk Inc. (Durham, NC)
- …any safety, quality , staffing or personnel issues & escalate to manager as necessary Ensure documentation meets GMP requirements Lead & manage maintenance ... 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
- Novo Nordisk Inc. (West Lebanon, IN)
- …position. This role will support our QC teams under the direction of the QC Manager . Relationships Reports to: Quality Control Manager Number of subordinates ... The Position This position has primary responsibility to support operations for Quality Control at our biologics manufacturing facility. Assists in coordination and… more
- Merck & Co. (Millsboro, DE)
- … Quality Control (QC) Associate Specialist, with Guidance from the QC Manager , ensures product/process quality through the review of GMP documentation and ... Job DescriptionOur Quality group ensures every single material inside our...and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements.- Partnering across our… 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 all ... 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)
- …study team on all aspects of statistical activities; collaborates closely with data manager to ensure high quality data. Work closely with internal statistical ... programmer.Drug Development Strategy: Provides input to multiple aspects of the development plan to ensure the study designs at each phase of the development are scientifically sound, can fulfill regulatory requirements and deliver the pre-specified product… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …role. This role is eligible for relocation assistance. Relationships Reports to: Quality Control Manager Number of subordinates with direct/indirect referral: ... together to contribute to a better tomorrow for our patients. Ethics and quality are held in the highest regard, and a patient-focused mindset guides everything… 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)
- …areas centered around rare diseases and immune disorders.SummaryThis Data Governance Communications Manager will be a critical part of the Center for Data Governance ... outcomes.- Support the creation and us of policies, processes, data standards, data quality and enabling IT and digital technologies needed to establish and maintain… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …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 ... personnel. Relationships Report to the Director/Associate Director/Lead Regulatory Scientist/Sr. Manager Regulatory Affairs. Develop and maintain positive rapport and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …DX Computer System Validation requirements, global regulatory compliance, and global Quality expectations. Partner with global Quality departments to review ... policies and procedures in collaboration with global DX and global Quality departments. Evaluates key performance indicators and participates in SDLC Lessons… more
