- Novo Nordisk Inc. (West Lebanon, IN)
- …to certify compliance with specifications and procedures Releases product based on Quality Assurance record review and approval by QA Manager Performs regular ... international regulatory agency preferred As applicable, experience with Quality Assurance oversight and support for all phases of Clinical and Production… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …requirements for CSV projects. Work within a risk-based framework (Computer Software Assurance (CSA)) that is compliant with global regulatory expectations and ... Non-GxP activities, assuring that these systems are compliant with global regulatory and Daiichi Sankyo requirements, and business expectations. Executes the Global… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Business Unit globally; promote a quality culture within Global Medical Affairs Quality Assurance by providing study team support to uphold the ethical conduct of ... adequate systems and process support, including facilitation of respective regulatory inspection preparation, management and follow-up in collaboration with impacted… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for support and manage Quality Management System (QMS) in accordance with regulatory requirements and to ensure the adherence to the Quality Manual. Responsible ... adherence to the implementation of global and harmonized Quality Standards and regulatory requirements for GMP area. Responsible for the creation and review Quality… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- Position Summary: Exela Pharma Sciences is seeking an experienced and dynamic Senior Manager , IS Quality to build and lead our IS Quality function. The ideal ... candidate will be responsible for ensuring compliance with regulatory requirements, industry best practices and internal standards as well as managing quality … more
- Insmed Incorporated (San Diego, CA)
- …join the Quality Control leadership team. As the QC Stability and Sample Management Manager , you will be responsible for the daily oversight for the QC stability and ... support associated investigations, including: temperature excursion assessments, client and regulatory requests, and investigational testing. Assist in creating a… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma.Legend Biotech is seeking QA Manufacturing Excellence Manager as part of the Quality team based in Raritan, NJ. Role OverviewThe ... QA Manufacturing Excellence Manager role is an exempt level position with responsibilities...working in an aseptic manufacturing facility, preferably in quality assurance , manufacturing compliance, clinical quality, MSAT or cell therapy.… more
- Merck & Co. (Durham, NC)
- Job DescriptionOur Quality Assurance group ensures every single material inside our products is manufactured, processed, tested, packaged, stored and distributed ... with our incredibly high standards of quality and meets all regulatory requirements.- Partnering across our internal manufacturing facilities, external contract… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …or material handling tasks in a backup role, as needed. Updates supervisor/ manager of work status or problems with recommendations for improvement or correction. ... decision making and troubleshooting skills in relation to procedures, regulatory standards, and company policies.Ensure non-conformances are investigated thoroughly… more
- Holtec International (Covert, MI)
- Regulatory Assurance Manager Holtec Decommissioning International (HDI) is currently seeking a Regulatory Assurance Manager to join the Palisades ... periodic reports and submission of performance indicator data. + Interpret regulatory rules and requirements specific to licensing basis commitments. + Oversee… more
- CIBC (Chicago, IL)
- …CIBC.com (https://www.cibc.com/en/about-cibc.html) This role is to lead the CIBC US Finance regulatory reporting quality assurance program that helps ensure the ... **Weekly Hours** 40 **Skills** Auditing, Compliance Reporting, Management Reporting, Quality Assurance (QA), Regulatory Reporting, Reporting Processes At CIBC,… more
- Tecomet (Lansing, MI)
- **Quality Assurance Manager ** **JOB SUMMARY:** The Quality Assurance Manager will provide overall company leadership and direction to meet customer ... quality requirements. This position will also create, monitor, and improve quality programs while reducing quality costs and maintaining compliance within FDA and ISO regulations. This is accomplished by utilizing Tecomet's standards of Safety, Quality,… more
- Constellation (Pottstown, PA)
- …Alignment\REG & LICENSING\2007 Licensing_NEW\2007 Sit Reg Assur_NEW\XLAH_Prin_Regulatory_Engineer_9107.doc Manager /Director/ Regulatory Assurance Manager ... includes bonus and 401K **PRIMARY PURPOSE OF POSITION** Performs advanced regulatory /technical problem solving and provides analysis/insights in support of nuclear… more
- Fortive Corporation (Everett, WA)
- **About the Job** The Regulatory Affairs and Quality Assurance Manager will provide Quality Management, Regulatory and Quality Engineering expertise, ... as well. + Minimum of seven years' experience in Quality Assurance and three years' experience in Regulatory Affairs in an FDA regulated industry. + Four year's… more
- Amazon (San Francisco, CA)
- …to invent, simplify, and automate compliance processes. This position will report to the Manager , Regulatory Compliance Assurance & Planning team in the ... and process to align AWS products and equipment to regulatory requirements. - Translate regulatory intelligence to...and equipment to regulatory requirements. - Translate regulatory intelligence to business operations. - Drive and scale… more
- Cole-Parmer (Franklin, MA)
- Job Title: Sr. Manager , Quality and Regulatory Assurance Reports To: VP, Quality Position Location: Franklin, MA FLSA Status (Exempt/Non-Exempt): FLSA ... Status: Exempt Position Summary: The Senior Manager , Quality and Regulatory Assurance position is responsible for the implementation and execution of the… more
- Champion Pet Foods (Auburn, KY)
- …pets too. We are excited to announce that we are looking for an Quality Assurance Regulatory Coordinator - 1st Shift to join our rapidly growing company. With ... administration of all functions associated with the facility and regulatory requirements to ensure open borders. This position is...markets out of DogStar. + Reports to the Quality Assurance Manager with APHIS facility audits for… more
- University of Pennsylvania (Philadelphia, PA)
- …wellness programs and resources, and much more. Posted Job Title Quality Assurance Specialist ( Regulatory ) CVPF(Center for Cellular Immunotherapy) Job Profile ... Title Research Coordinator Senior Job Description Summary The Quality Assurance Specialist will work within the Clinical Cell and...issuance and external audits, DFPs, CAPAs review. + Assisting Manager as needed to help with raw materials release,… more
- Alaka'ina Foundation Family of Companies (Frederick, MD)
- …and Social Science Support - Positions may include: Biostatistician; Clinical Data Manager / Regulatory Writer; Quality Assurance Officer; Regulatory ... Regulatory , Clinical, and Technical Clinical Trial support Location...and Volunteer Assistant; Volunteer Recruiter; Senior Volunteer Recruiter; Program Manager /Clinical Portfolio Manager ; Research Records Manager… more
- Curia (Albuquerque, NM)
- Manager , Manufacturing Quality Assurance in Albuquerque, NM Curia provides global contract research and manufacturing services to the pharmaceutical and ... biotechnology industries. The Manufacturing Quality Assurance (MQA) Manager leads all activities related...study + Minimum of five (5) years in Quality Assurance or Regulatory Compliance Management + Minimum… more
