- Cytiva (Pensacola, FL)
- …minimum of 4 years of leadership experience, with senior leadership roles in QA, Operations , or Quality Engineering preferred. Regulatory and Quality ... do: Quality Leadership & Compliance: Serve as the Pensacola site's Quality Management Representative, leading QA/QC functions, ensuring regulatory compliance,… more
- Pall (Miami, FL)
- …Danaher Business System which makes everything possible.Director Global Quality and Regulatory ComplianceJOB SUMMARYInterprets federal/state/international ... or material science fields with 15 years of progressive Regulatory compliance and / or quality assurance...Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex,… more
- Leica Biosystems (Miami, FL)
- …develop regulatory affairs skills.This position reports to the Director, Quality Assurance and Regulatory Compliance (Management Representative) and is part ... and will be an on-site role. In this role, you will have the opportunity to:Prepare, review and approve regulatory documentation for submission, including but… more
- Merck & Co. (Rahway, NJ)
- …relationships and effective communications with all stakeholders in all manufacturing operations , analytical testing, quality assurance, regulatory , etc. ... Job Description The Rahway based Senior Specialist, Global Development Quality Operations - API, is responsible for...all API are manufactured in compliance with cGMP and regulatory filings. Perform independent quality review and… more
- Insmed Incorporated (San Diego, CA)
- …Director of Clinical Quality Assurance (CQA) serves as a strategic leader managing quality and regulatory compliance related to GCPs, acts as quality ... (Essential Role Responsibilities):Establish and maintain a risk-based and scientific-based quality system to support GCP.Oversee regulatory agency inspections… more
- Pall (Miami, FL)
- …cross-functional teams including Manufacturing, Operations , R&D, Supply Chain, and Regulatory Affairs.Develop and manage the regional quality resource and ... Quality Director - Americas is responsible for leading and overseeing the quality strategy, systems, and operations across multiple sites within the assigned… more
- Beckman Coulter Diagnostics (Miami, FL)
- …compliance, and supply continuity risks.Collaborate with cross-functional teams across R&D, Procurement, Operations , Quality , and Regulatory Affairs to embed ... Supplier Quality organization-read on.In this role, you will have the opportunity to:Drive supplier quality strategies aligned with key commodity sourcing… more
- Repligen (Waltham, MA)
- …manage Supplier Change Notifications to ensure compliance with internal and regulatory quality standards.Coordinate cross-functional teams to assess and mitigate ... accountability, supporting root cause investigations, and ensuring Repligen's supplier network meets regulatory and quality standards. This role is based in… more
- Merck & Co. (Rahway, NJ)
- …solid understanding of integration and partnering for Pharmaceutical development/ CMC with Quality , Regulatory , Operations , Non-clinical, Clinical, and other ... ( our Manufacturing Division / our Research & Development Division ) such as Quality , Regulatory CMC, and technical functions, to ensure timebound progression of… more
- Aldevron (Miami, FL)
- …audit results.Serve as the site's primary contact with both customers and regulatory agencies regarding quality /compliance issues and Negotiate Quality ... final drug product manufacturing with incoming Quality Management Systems, Quality Assurance and regulatory audits required.Bachelor of Science required;… more
- Formation Bio (New York, NY)
- …role in scaling our biologics capabilities in partnership with technical, quality , and regulatory leaders.Responsibilities Strategic Leadership Develop and ... Collaboration & External Partnerships Partner closely with analytical development, manufacturing, quality , and regulatory teams to ensure seamless execution of… more
- Merck & Co. (Rahway, NJ)
- … requirements for CMC.- Strong understanding of integration and partnering with Quality , Regulatory , Operations , Non-clinical, Clinical, and other functional ... packaging, compatibility characterization for processing and administration, and supporting regulatory filings.Collaborate with key stakeholders across the organizations (Research… more
- Leica Biosystems (Miami, FL)
- …reports to the Manager, Quality Assurance and is part of the Quality Assurance and Regulatory Compliance Department located in Richmond, Illinois and will ... Danaher Business System which makes everything possible.The Senior Histotechnician, Quality Control, is responsible for developing and implementing testing,… more
- Cepheid (Miami, FL)
- …degree in field with 2+ years of related work experience.Functional knowledge of Quality , Regulatory Compliance, and operations systems and processes to ... includes assessing complaints cross functionally for reportability decisions to regulatory authorities, ie, submitting Vigilance and Medical Device Reporting… more
- Merck & Co. (Rahway, NJ)
- …particularly in the design, manufacturing, verification, validation and associated quality and regulatory aspects of combination products.The incumbent ... set tactical and strategic direction on programs to ensure delivery of high- quality products, test methods, and robust manufacturing processes for both clinical and… more
- Cytiva (Miami, FL)
- …the Quality Director - Global Strategic Accounts and is part of the Global Quality Assurance and Regulatory Affairs. This role can be located at any Cytiva ... reviewsWho you areBachelor's degree and minimum 5+ years' work experience in a Quality or Regulatory Assurance related field including Biopharma or Life… more
- BioAgilytix (Durham, NC)
- …tools that boost lab productivity and keep BioAgilytix ahead of regulatory requirements.Key ResponsibilitiesData Governance & Quality Standards:Develop a ... insights.Cross-Functional Collaboration and Future Team Development:Work closely with IT, lab operations , and quality /compliance teams to ensure alignment on… more
- Eisai, Inc (Exton, PA)
- …will collaborate effectively with other Development groups as well as with Facilities, Quality Assurance, Quality Control, Regulatory , and CMC Program ... and close-out reports for Biologics Pilot Plant campaigns. Support providing data for regulatory documents as required.7. Ensure adherence of operations to cGMP,… more
- Aequor (Hicksville, OH)
- …employees. Adheres to all applicable procedures, cGMP's, company policies, and all other quality or regulatory requirements (OSHA, DEA, FDA, EMEA, ANVISA, HS&E, ... breaks.Job Purpose Able to perform various inspecting, labelling and packaging operations . Tends machines that perform one or more packaging functions, such… more
- Aequor (Hicksville, OH)
- …occur. Adheres to all applicable procedures, cGMP's, company policies, and all other quality or regulatory requirements (OSHA, DEA, FDA, EMEA, ANVISA, HS&E, ... with bulk products and components. Perform various filling and packaging operations . Major Accountabilities Supplies production line with product and packaging… more
