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Negotiates cross-functionally, successfully motivates and influences (Clinical Development, Regulatory Affairs, CMC, QA, Pharmacovigilance, etc.) Cross-functional clinical processes, including data management, biostatistics, medical writing, drug safety/pharmacovigilance, and regulatory affairs.
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Collaborate with the Project Management and CMC teams and related functions, including discovery, non-clinical development, Formulation, Analytical Development, QA, and CMC Regulatory Affairs.
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As a Senior QA Associate, Compliance/QA Lead , you would be responsible for ensuring product compliance to established cGMPs, to meet safety and quality standards for FDA Regulatory and customer requirements by adherence to Standard Operating Procedures (SOPs.
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Regulatory and QA Specialist Our client is a highly regarded manufacturer of flavors and essential oils. Qualifications 1-3 years of Regulatory/QA experience in food industry and/or flavor industry.
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The Living Therapeutics Initiative seeks a highly motivated Regulatory Affairs Senior Manager to manage the regulatory affairs, author and assemble IND applications, and help manage FIH studies advancing UCSF-developed cellular therapy candidates.
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To do these effectively, the Analyst III – Policy & Regulatory Operations must have a demonstrated understanding of IEHP business operations and responsibilities of various departments in Health Services, Quality Systems, Provider Services, and Member Services; subject matter expertise of these departments’ policies and procedures and the regulations that drive their business operations and demonstrated ability to effectively and consistently manage multiple projects and priorities concurrently.
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The Senior Director, QARA is principally responsible for the development and implementation of the Company's quality assurance program through the development and implementation of quality assurance and compliance standards via policies and procedures, training, auditing and monitoring, facilitating internal reporting, compliance-related investigations, and keeping Third Party Logistics VP of Quality Assurance & Regulatory Affairs informed on quality assurance and regulatory affairs matters.
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The Senior Director, Quality Assurance and Regulatory Affairs (QARA) collaborates to set policy and procedures and then audits/monitors quality assurance. The Senior Director, QARA and his or her designees have the authority to review all documents and other information that are relevant to quality assurance and regulatory affairs activities.
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The role will report directly to Senior Vice President of Regulatory Affairs at Ultragenyx. A scientific degree with directly relevant professional experience in global CMC regulatory affairs and CMC technical areas of at least 15 years with a BA/BS, MA/MS, PhD or PharmD.
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QA Compliance Manager. Collaborate with departments such as business and QA in handling quality incidents and providing technical support. Be familiar with FDA regulatory requirements on data integrity and data governance on computerized systems.
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Participate in regulatory audits and perform acting QA Manager duties during the QA Manager's absence. This includes overseeing quality control procedures from raw milk intake to packaging, conducting inspections, implementing corrective actions when necessary, and maintaining compliance with regulatory requirements.
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The QA Manager will support Civica's quality and regulatory technology implementation and ensure the software and applications comply and adhere to regulatory expectations, such as 21 CFR Part 11, data integrity, current Good Manufacturing Practice (cGMP) guidance documents, and GAMP5.
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Support the QA Manager during client and regulatory audit, client audits for records review. Responsibilities PRINCIPAL DUTIES AND RESPONSIBILITIES Under the guidance and direction of the QA Manager, essential functions of the QA Auditor include: Operate within the Quality Management Systems applicable to Investigational New Drugs, and Good Tissue Practices.
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Years’ experience in product stewardship, regulatory affairs, compliance, chemical consultancy, and/or risk assessment. Maintain up-to-date knowledge of current and future product stewardship, chemical regulatory compliance, and sustainability issues through membership in trade associations and external committees, regular review of relevant publications and subscription services, and interactions with external experts and advisors.
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Position Title: Counsel/Senior Counsel, Regulatory Affairs (position title and compensation is commensurate with experience) Reports to: Executive Vice President and Managing Director, Chief Counsel, Head of Global Regulatory Affairs.
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qa manager senior regulatory affairs jobs Title: quality manager
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