- Merck & Co. (Upper Gwynedd, PA)
- … regulatory issues to GRACS CMC management, as neededDemonstrate an understanding of regulatory affairs and apply this understanding to the benefit of the ... related pharmaceutical operations (eg, manufacturing, formulation and process development, analytical, quality assurance , n ovel modality and technologies such… more
- AUROBINDO (Durham, NC)
- …team with expertise in manufacturing, R&D, Quality Assurance and Quality control and regulatory affairs . In addition to several formulations ... customs and the FDA. The position is also required to work closely with Quality Control to make sure that the process flows smoothly from receiving the product… more
- AUROBINDO (Durham, NC)
- …team with expertise in manufacturing, R&D, Quality Assurance and Quality control and regulatory affairs . In addition to several formulations ... under manufacture, we have a robust pipeline of products. Aurolife's aim is to provide healthcare at economical prices to make this a healthier world to live in.Job OverviewDedicated, knowledgeable, responsible/ reliable employee who can work in a fast-pace… more
- AUROBINDO (Dayton, OH)
- …team with expertise in manufacturing, R&D, Quality Assurance and Quality control and regulatory affairs . In addition to several formulations ... and investigations under the direction of a supervisor.8. Comply with all regulatory /in-house requirements (may include but not limited to safety, house keeping,… more
- Twist BioScience (South San Francisco, CA)
- …the platform architecture and infrastructure teams, Manufacturing Operations, Quality Assurance , Process Development, and Regulatory Affairs teams to ... MES professionals, primarily software developers, who work in concert with Manufacturing Operations, Quality Assurance , and R&D. The Director will serve as the… more
- AUROBINDO (Durham, NC)
- …team with expertise in manufacturing, R&D, Quality Assurance and Quality control and regulatory affairs . In addition to several formulations ... under manufacture, we have a robust pipeline of products. Aurolife's aim is to provide healthcare at economical prices to make this a healthier world to live in.Job OverviewThe Human Resources Business Partner will provide support in the following functional… more
- Pall (Miami, FL)
- …fields with 15 years of progressive Regulatory compliance and / or quality assurance experience.Thorough understanding of ISO 9001 and AS9100 / CAA Part ... the Danaher Business System which makes everything possible.Director Global Quality and Regulatory ComplianceJOB SUMMARYInterprets federal/state/international regulations… more
- Foresight Diagnostics (Boulder, CO)
- …62304, ISO 14971, ISO 13485). *Work closely with R&D, Quality Assurance , Manufacturing, and Marketing teams to ensure regulatory requirements are integrated ... Diagnostics is headquartered in Boulder, Colorado. About The Role The Regulatory Affairs Specialist supports our product teams supporting new product development… more
- Abbott (Santa Clara, CA)
- …experience in regulatory preferred but may consider quality assurance , research and development/support, scientific affairs , operations, or related area. ... catheters and software, vessel closure devices and peripheral stents. This Senior Regulatory Affairs Specialist position is an onsite opportunity working out… more
- AbbVie (North Chicago, IL)
- …for future success. Develop, support and execute a holistic quality assurance model for regulated Medical Affairs and RWE generating activities, inclusive ... of drug/device development programs. Associate Director, Safety, Medical & Regulatory Quality is part of the R&D...of Medical Affairs , RWE generation, epidemiology, and/or quality assurance supporting those areas. 5 years… more
- Bioventus (Valencia, CA)
- …Conduct research, feasibility studies, and in vivo testing. Interact with Regulatory Affairs , Sales & Marketing, Quality Assurance , and Supply Chain ... Management. Comply with FDA and other regulatory requirements. Support physician visits. Travel may be required occasionally. Education and Experience (Knowledge,… more
- Fred Hutchinson Cancer Center (Seattle, WA)
- … binders and electronic files eg SharePoint, OneDrive, OnCore. Perform internal audit and quality assurance checks on regulatory documents. With input from ... innovative ways of seeing the world and solving problems. The Senior Regulatory Affairs Associate works with faculty and staff in the Infectious Disease Sciences… more
- Vertex Pharmaceuticals (Boston, MA)
- …teams, including Analytical Development, AS&T, CMC, Supply Management, Regulatory Affairs , Program Management and Quality Assurance , as well ... Job Description General Summary: The Manager of Quality Control will be responsible for supporting the...and internal procedures. Work with CMC technical SMEs and Regulatory to prepare and review QC related sections of… more
- HonorVet Technologies (San Jose, CA)
- …will work closely with cross-functional teams, including Engineers, Scientists, Regulatory Affairs and Quality Assurance , to ensure accurate and timely ... SOP) Reviews and audits other technical publications deliverables and consistently delivers quality documentation. As regulations change and quality systems are… more
- Celularity Inc. (Florham Park, NJ)
- …and preventive actions (CAPAs) as necessary. Collaborate with cross-functional teams, including Quality Control, Manufacturing, and Regulatory Affairs , to ... as it applies to phase-appropriate method development and validation preferred. Certification in Quality Assurance or Sterility Assurance (eg, ASQ, PDA) is… more
- Synectics Inc (Dublin, CA)
- …between facilities. Cross-functional Collaboration: Work closely with cross-functional teams, including R&D, Quality Assurance , Regulatory Affairs , and ... Compliance: Ensure all transferred processes comply with relevant industry standards, regulatory requirements, and quality assurance protocols. Equipment… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …around rare diseases and immune disorders. JOB SUMMARY The Senior Director, Head Medical affairs Quality Assurance in Global RD/PV QA is accountable to ... stakeholders. The role will manage and or support medical affairs Quality resources (US, Brazil, Japan/ APAC...and compliance Marketing/ commercial GMP QA/ Supply chain / Regulatory Affairs Leadership/ team management: Create a… more
- Asklepios BioPharmaceutical, Inc. (Durham, NC)
- …Development Medical Affairs , Regulatory Affairs , Product Quality Compliance, Quality Assurance , Translational Medicine etc. This position ... database Provide input in responding to and resolving safety questions from regulatory authorities Oversee production of regulatory periodic safety submissions… more
- Vanderbilt Health (Nashville, TN)
- …meetings to develop resolution to problems. Identify, establish and evaluate quality assurance standards, programs, and procedures within department. Establish ... through preeminent programs in patient care, education, and research. Organization: Quality Admin Job Summary: The Associate Director supervises, coordinates and… more
- BEL (Little Chute, WI)
- …to support departmental objectives. Work in conjunction with the Analyst, Quality Assurance and Regulatory Affairs and/or Manager, Quality and ... data entry into Quartz module. Provide back-up to Analyst, Quality Assurance and Regulatory Affairs and Sr. Manager, Quality and Regulatory… more
