- Aequor (Providence, RI)
- …diverse functional areas including Supply Chain, Manufacturing, Quality Control, Regulatory , Quality Assurance , Quality Engineering, International ... pharmaceutical sciences field and experience with growing responsibility in a quality , analytical development, process development, pharmaceutics, regulatory , or… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … Affairs, Quantitative Clinical Pharmacology, Clinical Safety and Pharmacovigilance, Regulatory /Risk Management, Quality Assurance , Medical Affairs, ... efficient, adaptable, and scalable architectures in accordance with company policies, regulatory standards, and integration methodology. Work with the business users… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … Affairs, Quantitative Clinical Pharmacology, Clinical Safety and Pharmacovigilance, Regulatory /Risk Management, Quality Assurance , Medical Affairs, ... users to define user information needs.Provide informatics project management, SDLC Quality Model expertise, and computer system validation expertise to deliver… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …focus even under adversity Operational mindset and continuous improvement: Considers compliance, regulatory , quality assurance and other requirements when ... this leader enables all activities related to the successful acquisition of high- quality goods/services at the best possible prices and business terms for NNI.… more
- Tris Pharma (Monmouth Junction, NJ)
- … provides strategic leadership and direction for Clinical Quality Assurance Operations, ensuring compliance with regulatory standards and driving ... Tris has an immediate opening for a full-time permanent Director/Senior Director, Clinical Quality Assurance . This is a hybrid position. Job Title commensurate… more
- BioAgilytix (San Diego, CA)
- …therapeutics to the patients who need them.Essential Responsibilities Performs Quality Assurance (QA) audits, inspections (internal/external), and monitoring ... QA statements for reports as needed Assist in hosting regulatory inspections by acting as scribe and/or reviewing documents...Not less than three (3) years' experience in GLP/GCLP/GMP quality assurance (QA) Experience working in biotech,… more
- Merck & Co. (Durham, NC)
- …patients on time, every time, across the globe.-The main functions of the Specialist, Quality Assurance is to assist in the review of records, investigations, ... methods, protocols, and trend reports .-Provide support to all Quality related audits from external and regulatory ...all Quality related audits from external and regulatory agencies .-Participate in Quality Risk Assessments… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …or a leading international regulatory agency preferred As applicable, experience with Quality Assurance oversight and support for all phases of Clinical and ... records. Will be a QA presence on the manufacturing floor. Relationships Quality Assurance . Essential Functions Reviews all manufacturing and support records… more
- Aequor (Seattle, WA)
- … standards and company policies. 2. Deviation Management: Collaborate with laboratory staff, quality assurance , and regulatory affairs teams to document and ... a related role within a clinical laboratory or regulated environment. Familiarity with regulatory guidelines (eg, CLIA, CAP, ISO) and quality management systems.… 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 ... information flow based on read outs from audits, inspections, Quality Events, regulatory intelligence, effectiveness checks on...annual Quality Plan for Global Medical Affairs Quality Assurance , PVQA strategic plans and the… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …industry best practices and internal standards as well as managing quality assurance processes and leading continuous improvement initiatives within ... our IS department. This role involves a strategic partnership with the Quality Assurance department and cooperation with various stakeholders to enhance … 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 ... various contractors meets Global DX Computer System Validation requirements, global regulatory compliance, and global Quality expectations. Partner with global… 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 ... aligned with our incredibly high standards of quality and meets all regulatory requirements.- Partnering...consumables, as well as interact with Production, Technology, and Quality Assurance as required to support vaccine… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … regulatory requirements for GMP area. Responsible for the creation and review Quality Assurance Agreements with contract organization and to manages a ... diseases and immune disorders.Summary Accountable for support and manage Quality Management System (QMS) in accordance with regulatory...Quality Assurance Agreement system which provides a… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research relevant duties under the RDPV QA function to ensure that Quality assurance oversight are being addressed and managed appropriately. Ability to ... with expertise in: oncology, biologics or vaccines.Must have proven expertise within Quality Assurance Research to support Global Research QA including… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …teams, and supports change implementation. Coordinates with regional/global RACMC, Quality Assurance , Pharmaceutical Technology, and other functional areas ... The Associate Director, RACMC Portfolio Products, will be responsible for regulatory CMC (Chemistry, Manufacturing, and Controls) activities of the portfolio small… more
- Insmed Incorporated (San Diego, CA)
- …systems for stability and sample management (eg, JMP, Labware LIMS)Collaborate with Quality Assurance , Manufacturing and CMOs, Material Management, and other ... fast paced, collaborative, and multidisciplinary team. This individual will join the Quality Control leadership team. As the QC Stability and Sample Management… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …or equivalent technical discipline is requiredA minimum of six (6) years of experience in Quality Assurance / Quality Systems or Compliance with a minimum of ... OverviewThe Quality Compliance- Lead Auditor CAR-T is responsible for regulatory compliance supporting the production of autologous CAR-T products for clinical… more
- Signature HealthCARE (Columbus, OH)
- …health, cognitive care, and telemedicineA growing number of our centers are earning quality assurance accreditation and pioneering person - directed careMany of ... systems and standards of care are in place to achieve clinical, regulatory , and reimbursement complianceProvide oversight and guidance to staff in assigned… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …industry practicesStrongly interface with Operations Department and other supporting groups (Engineering, Quality Control, Quality Assurance and other as ... engineer/scientist during his/her absence.Assist management during internal and external regulatory audits (including FDA, EMEA)Establish key stakeholder relationships with… more
