- Merck & Co. (North Wales, PA)
- Job DescriptionPrincipal Scientist / Director, GLOBAL REGULATORY CMC Biologics (R5)Under general supervision of an Executive Director/Senior Director, the Principal ... for developing and implementing Chemistry, Manufacturing, and Controls (CMC) regulatory strategies for our organization's biologics product franchises in accordance… more
- Merck & Co. (Rahway, NJ)
- …for sustained launch in alignment with the company's business goals, and quality and regulatory compliance .-Essential Duties and Responsibilities:Program ... and performance of team members, fostering a collaborative and innovative team environment. Regulatory Compliance and Quality Assurance:Ensure that all… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …tracking of labeling milestones. Collaborates with Global Labeling Operations and Compliance Leads to produce high quality labeling documentation.Establishes ... serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational...development or approval for either the US or EU.Ensure Compliance with Core Data Sheets/Label Changes: Manages updates to… more
- Tris Pharma (Monmouth Junction, NJ)
- …leadership and direction for Clinical Quality Assurance Operations, ensuring compliance with regulatory standards and driving implementation and continuous ... has an immediate opening for a full-time permanent Director/Senior Director, Clinical Quality Assurance. This is a hybrid position. Job Title commensurate with… more
- Eisai, Inc (Exton, PA)
- …CTAs) and agency communications (responses to questions) are prepared in compliance with the applicable regulatory requirements and scientific ... Job Summary Implements global chemistry, manufacturing and control (CMC) regulatory strategies throughout the lifecycle of pharmaceuticals. Coordinates the… more
- Lovelace Biomedical Research Institute (Albuquerque, NM)
- …and effectively, and within budget. Regulatory Oversight: Uphold the highest standards of quality and compliance with all regulatory bodies to include the ... Will utilize prior academic experience to optimize resource allocation, ensure regulatory compliance , and uphold rigorous scientific standards. Understanding… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …by various contractors meets Global DX Computer System Validation requirements, global regulatory compliance , and global Quality expectations. Partner with ... amount of system validation or qualification needed to achieve and maintain regulatory compliance regardless of service methodology (SaaS, On-Prem, Service… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …the Quality team based in Raritan, NJ. Role OverviewThe Quality Compliance - Lead Auditor CAR-T is responsible for regulatory compliance supporting ... the treatment of multiple myeloma.Legend Biotech is seeking Quality Compliance Lead as part of...independent audits; manage audit responses and observation resolution.Drive site compliance to regulatory , enterprise, and global requirements… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …with legal and compliance as required. Proactively collaborate with other GxP quality representatives and act as QA point person for US and EU Medical Affairs ... learned information flow based on read outs from audits, inspections, Quality Events, regulatory intelligence, effectiveness checks on process implementations… more
- Tris Pharma (Monmouth Junction, NJ)
- …and Preventative Actions (CAPAs) and Continued Process Improvements (CPIs), Product Quality Complaints (PQC) documentation, compliance efforts, quality ... limited to: investigative processes, CAPAs and CPIs, etc.Participates in regulatory agency inspections and customer audits, as needed; Performs...in science or related field and minimum 6 years quality and/or cGMP compliance experience in the… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …efficient execution of critical quality tasks. Fostering efficiency, maintaining compliance with cGMP and other relevant regulatory requirements, and ... documents, such as Standard Operating Procedures, Work Instructions, Deviations, and other quality documents for cGMP compliance and consistency with FDA… more
- Merck & Co. (Durham, NC)
- …packaged, stored, and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements.- Partnering across our internal ... Job Description Job Description: Our Quality Assurance group ensures every single material inside...position is accountable for performing lot release testing in compliance with standard operating procedures, safety, and cGMP regulations.… more
- Merck & Co. (Durham, NC)
- …packaged, stored and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements. Partnering across our internal ... Job DescriptionJob DescriptionOur Quality Assurance group ensures every single material inside...protocolsComplies with policies and procedures in order to maintain compliance with legal.regulations, health and safety, and regulatory… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …will review manufacturing and support documentation and records to certify compliance with in-house specifications/standards and GMP for all NNUSBPI products. This ... and reporting/trending Reviews manufacturing and support records to certify compliance with specifications and procedures Works closely with Manufacturing and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …tracking of labeling milestones. Collaborate with Global Labeling Operations and Compliance leads to product high quality labeling documentation.Establishes ... tracking of labeling milestones. Collaborates with Global Labeling Operations and Compliance Leads to produce high quality labeling documentation.Establishes… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …or biologic facility regulated by the FDA, EMEA or a leading international regulatory agency preferred As applicable, experience with Quality Assurance oversight ... to a better tomorrow for our patients. Ethics and quality are held in the highest regard, and a...of manufacturing and support documentation and records to certify compliance with in-house specifications/standards and GMP for all NNUSBPI… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …technologies/ Implementing strategic and tactical plans to drive sustainable improvements.Supports Regulatory Affairs in providing quality content and review of ... that outsourced obligations are in compliant and prepared for regulatory submissions and / or inspections Ensures that appropriate...a phase appropriate quality system that supports quality and compliance of Good Clinical Laboratory… more
- Insmed Incorporated (San Diego, CA)
- …fast paced, collaborative, and multidisciplinary team. This individual will join the Quality Control leadership team. As the QC Stability and Sample Management ... support associated investigations, including: temperature excursion assessments, client and regulatory requests, and investigational testing. Assist in creating a… more
- Tris Pharma (Monmouth Junction, NJ)
- …builds in-house analytical capabilities, when needed. The incumbent ensures timeline, quality and compliance with applicable Standard Operating Procedures ... (FDA) guidance and provides technical guidance within and outside R&D for regulatory and quality matters.The Associate Director/Director, AR&D serves as Deputy… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …manage relationships with contractors to ensure quality of work and compliance with all company policies and regulatory guidelinesHelps improve metric ... focused on an EHS first mindset, a Right First Time culture of quality , permanent inspection readiness compliance mindset and passionately drives continuous… more
