- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition Description:The Vice President, Regulatory Affairs, General Medicine, will contribute to the mission and vision of the Global Regulatory ... strategy with US FDA and global health authorities to advocate advanced regulatory strategies for novel medicines.Contributing to the continuous improvement of the… more
- Merck & Co. (Rahway, NJ)
- … investigations with a strong focus on quality and regulatory compliance.Excel in impurity isolation, unknown peak identification, characterization of degradation ... transfer protocols and reports, technical reports, experimental designs, and regulatory submission documents, etc.Perform investigations with strong technical… more
- Tris Pharma (Monmouth Junction, NJ)
- …liaison with Product Development (PD)/Quality Assurance (QA)/Quality Control (QC)/ Regulatory Affairs, including reviews/approvals of Change Control Reports (CCRs), ... assigned projects regularly reporting status/issues to management, conducts laboratory investigations and recommends appropriate Corrective Action Preventive Action (CAPAs)/CPIs… more
- Repligen (Waltham, MA)
- …including deviation support, root cause analysis, customer complaint management, hosting customer/ regulatory audits and Certificate of Quality generation at an ISO ... 9001 for all aspects of the QMS including but not limited to Internal and External Auditing, Nonconforming Materials, CAPA, Validation, Change Controls, and other… more
- Merck & Co. (Rahway, NJ)
- …of clinical development, including study design, placement, monitoring, analysis, regulatory reporting, and publication.Specifically, the Director may be responsible ... as new drug applications, clinical study reports, or publication; andParticipation in internal and joint internal /external research project teams relevant to the… more
- Aequor (Tampa, FL)
- …and interprets QC and microbial limits testing according to USP and regulatory requirements for raw materials, finished products, and stability samples. Perform ... sampling and testing. Performs microbiology methods and sampling techniques. Performs investigations and completes CAPA in response to laboratory investigations .… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …global manufacturing network for best-in-class CAR-T product.Work collaboratively with internal and external partners to drive global process platform improvements ... on process platform parameters, unit operations and analytical methods at both internal and external CMO sitesEnsure global records are consistent and maintained to… more
- Repligen (Waltham, MA)
- …plays a key role in driving supplier accountability, supporting root cause investigations , and ensuring Repligen's supplier network meets regulatory and quality ... (SCNs)Evaluate and manage Supplier Change Notifications to ensure compliance with internal and regulatory quality standards.Coordinate cross-functional teams to… more
- Eisai, Inc (Raleigh, NC)
- …position is responsible for executing core quality assurance functions, supporting regulatory inspections, and collaborating with internal and external ... \tReviewing and making disposition decisions for manufactured product batches. \tSupporting investigations and evaluating the impact of deviations or events on… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …first time), schedule adherence, and productivity improvements.Support manufacturing investigations , support and manage change controls, and maintain permanent ... inspection readiness and actively support regulatory inspections.Lead facility operating review meetings and sponsor various department projects to drive continuous… more
- Merck & Co. (Rahway, NJ)
- …in interpreting trends from commercial process monitoring, driving further investigations and process improvements that elevate our standards.Engage Across ... Functions: Actively interact with internal and external partners, representing your functional area on cross-functional teams to foster collaboration and… more
- Merck & Co. (Rahway, NJ)
- …environment that provides substantial technical responsibility and leadership of internal and external work.The Senior Scientist, Engineering position leverages ... scales.The successful candidate will play a pivotal role in developing internal technical capabilities via mentoring junior staff and enhancing fermentation and… more
- Merck & Co. (Rahway, NJ)
- …lists, qualification documentation, calibration documentation, computer system inventories Support internal and external quality audits and maintain laboratory state ... contribute to Standard Operating Procedures (SOP) draftingOriginate and own Investigations and Change Management recordsThe successful candidate must function both… more
- Merck & Co. (Durham, NC)
- …(with appropriate escalation as required). Resolve Technical Issues ( Investigations , CAPAs, Process Improvements, Source Changes, Technical Transfers, Equipment ... of information disclosure and maintain confidentiality when dealing with multiple internal and external stakeholders.- Supplier Relationship Management - Ability to… more
- AUROBINDO (Durham, NC)
- …with expertise in manufacturing, R&D, Quality Assurance and Quality control and regulatory affairs. In addition to several formulations under manufacture, we have a ... employee concerns and workplace issues.Assist in resolving conflicts, conducting investigations , and recommending disciplinary actions when needed.Foster a positive… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …alignment to Global Procedures.Act as a Site MES SME to support Quality Investigations , Corrections, and QMS records.Build the Site Readiness of MES for FDA and/or ... Other Regulatory Audits / Inspections.This individual is responsible for the...updates and impact.Key Relationships: establish key stakeholder relationships with internal and external stakeholders. Ability to interact with all… more
- RTX Corporation (Tewksbury, MA)
- …for a **Senior Manager, Global Trade Investigations ** who will manage internal investigations related to regulatory and policy violations specific ... and Antiboycott. **What You Will Do:** + Manage a dynamic caseload of internal regulatory and policy violation investigations . + Monitor and manage legal… more
- DHL Express, Inc. (Washington, DC)
- …customs and other regulatory issues. + Advise DHL business units on internal investigations and voluntary disclosures concerning the regulatory areas ... Canada, Mexico, Brazil, etc.). + Experience managing or contributing to internal investigations on trade or regulatory compliance violations including the… more
- JPMorgan Chase (New York, NY)
- …& Co. in connection with regulatory inquiries and government enforcement matters, internal reviews and investigations . You will spend your day learning about ... and inquiries + Conduct internal reviews and investigations ; Assist with internal and regulatory audits + Participate in periodic compliance… more
- Children's Hospital Los Angeles (Los Angeles, CA)
- …10+ years of litigation and investigation experience to internal investigations across legal areas employment, regulatory , workers' compensation, and general ... advice to stakeholders on a number of legal and regulatory issues. + Experience with regulatory bodies...trial. + Ability to proactively approach all aspects of internal and external investigations from planning through… more
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