- 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. (Durham, NC)
- …and approving of samplesProvide active support during audits and inspections ( regulatory , internal , safety)Assist regulatory groups by providing ... Notification authoring and provide audit support. GENERAL PROFILE: Collaborate with internal customers and vendors to identify, evaluate, and implement new… 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- TD Bank Group (Mount Laurel, NJ)
- …the ability to lead, train and mentor teams in conducting thorough investigations , ensuring regulatory compliance, and maintaining high standards of accuracy. ... Job Description: Department Introduction: The Group Manager, Financial Crime Risk Investigations manages/leads a team of investigators conducting end to end BSA/AML… more
- Cipla (Central Islip, NY)
- …of Cipla's US Subsidiaries or Affiliates. Job Title QMS Lead - Investigations Organization Name InvaGen Pharmaceuticals, Inc. Location Central Islip, NY Employment ... Accountabilities Lead of investigation team and involve in conducting thorough investigations related to Out of Specifications (OOS), Out of Trend (OOT),… more
- MUFG Bank, Ltd. (New York, NY)
- …Training as well as ad hoc trainings. Participating in internal investigations , assisting in responding to regulatory inquiries, and coordinating internal ... Our ideal candidate will possess a strong understanding of regulatory compliance, risk management, and business operations. This role...proposed and new rules in addition to market and internal developments and provide advice and guidance on the… more
- Artech LLC (Hopkinton, MA)
- …This position will work closely with manufacturing personnel, operational leaders, and internal and external customers. *Inspection of materials from internal or ... system, etc. *Support project teams on corrective actions, root cause investigations , and other continuous improvement activities. *May require flexibility to work… more
- Kobre & Kim LLP (Wilmington, DE)
- …collaborate on cross-border teams that handle matters involving criminal defense and regulatory enforcement; internal investigations ; civil and commercial ... litigation; class actions; judgment enforcement and asset recovery; and financial products and services disputes. Being part of our team will give you experience unrivaled in the world of premium high-stakes litigation. We recognize that our greatest asset is… more
