- 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
- 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
- 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
- Merck & Co. (Rahway, NJ)
- …launch in alignment with the company's business goals, and quality and regulatory compliance.-Essential Duties and Responsibilities:Strategic Leadership ... collaboratively with receiving sites, drug product partners, and Technical Product Leaders, regulatory and quality .Provide Voice of Manufacturing input to early… 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
- 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)
- …to: Lead and oversee analytical investigations with a strong focus on quality and regulatory compliance.Excel in impurity isolation, unknown peak identification, ... leadership and collaboration.Maintain a deep understanding of the regional regulatory and business environment, including:API and Drug Product development needsGMP… 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
- Tris Pharma (Monmouth Junction, NJ)
- …coordinates and advances required documentations, in liaison with Product Development (PD)/ Quality Assurance (QA)/ Quality Control (QC)/ Regulatory Affairs, ... performs analytical method validations and release/stability raw materials, in process ( IP ), finished products (FP) and stability (ST) samples for pilot and… 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
- 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
- Insmed Incorporated (San Diego, CA)
- …for trend analysis are also key duties. Collaboration with R&D, Process Development, Quality Control, and Regulatory Affairs is essential, as is facilitating ... for Millennials™, and Best Medium Workplaces™ lists.OverviewLead Analytical Development Operations function to build out the process development support testing… more
- Aequor (Thousand Oaks, CA)
- …will need to demonstrate knowledge of DP technical process, manufacturing operations , scientific method, basic regulatory compliance expectations, and ... to peers and senior leadership team. Additional Responsibilities include: Engaging with Quality and Regulatory teams to ensure alignment and compliance across… 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
- Twist BioScience (South San Francisco, CA)
- …of QC methods in the production laboratory. He/she will work closely with the operations team to monitor the quality of Twist DNA products utilizing quantitative ... by collecting, analyzing, and summarizing information and trendsWrite/review product quality documentationFollow regulatory and ISO 13485 requirementsWhat You'll… more
- Twist BioScience (South San Francisco, CA)
- The Regulatory Operations Specialist is responsible for ensuring the efficient and compliant management of regulatory documentation, with a primary focus on ... combination of education and work-related experience. Minimally 2 years of experience Regulatory Operations within a biotechnology, life sciences, or chemical… more
- Merck & Co. (Rahway, NJ)
- …Metrology Equipment, Personal Initiative, Pharmaceutical Management, Pharmacy Regulation, Quality Auditing, Regulatory Compliance, Reviewing Literature {+ ... of the integrated US Metrology and Validation team and drive a culture of quality and operational excellence across the global AR&D network. The role oversees and… more
- Aequor (Hicksville, OH)
- …assigned Adheres to all applicable procedures, cGMPs, company policies and any other quality or regulatory requirements. (For example: OSHA, DEA, FDA, EMEA, ... observing all safety regulations and ensuring all cGMP and quality standards are met and to maintain the efficient...check on equipment to be used in the daily operations and ensure that all safety devices are functioning… more
- Tris Pharma (Monmouth Junction, NJ)
- …optimal stock levels and minimize obsolescence; Ensures compliance with safety, quality , and regulatory standards in warehouse operationsManages, coaches and ... small team to develop and implement procurement strategies and operations , contract negotiations, supplier relationship management, procurement systems functionality/workflows… more
