- Merck & Co. (Rahway, NJ)
- …and effective implementation and oversight model to maintain best in industry regulatory compliance .The Vice President Regulatory Affairs, General Medicine ... Requirements: Flexible Work Arrangements:HybridShift:Valid Driving License:Hazardous Material(s):Required Skills:Business, Business, Compliance Investigations , Confidentiality, Cross-Cultural Awareness, Detail-Oriented, Document… more
- Merck & Co. (Durham, NC)
- …Control will be responsible for activities that support cGMP and regulatory compliance during method qualification/validation and routine product activities ... for the company; uses this knowledge in own workUnderstands and applies regulatory / compliance requirements relative to their roleInfluence, motivate, and… 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)
- …Teamwork, Data Analysis, Hematology, Intellectual Curiosity, Medical Research, Oncology, Regulatory Affairs Compliance , Regulatory Reporting, ... of clinical development, including study design, placement, monitoring, analysis, regulatory reporting, and publication.Specifically, the Director may be responsible… 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 ... Chromatography & Proteins.ResponsibilitiesThe Director, Quality will be responsible for:Maintaining site compliance to ISO 9001 for all aspects of the QMS including… more
- Eisai, Inc (Raleigh, NC)
- …position is responsible for executing core quality assurance functions, supporting regulatory inspections, and collaborating with internal and external ... The QA Specialist plays a critical role in ensuring the quality and compliance of commercial and clinical products manufactured at the Eisai Raleigh facility. This… more
- Merck & Co. (Rahway, NJ)
- …Personal Initiative, Pharmaceutical Management, Pharmacy Regulation, Quality Auditing, Regulatory Compliance , Reviewing Literature {+ 4 more}-Preferred ... Analytical Research & Development (AR&D) External Capabilities, Validation, and Compliance (ECVC) department of our company's Research Laboratories Division is… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …teams, manage performance, and develop talent. Ability to create an engaged workforce.GMP Compliance & Regulatory Knowledge: Deep understanding of FDA, EMA, and ... (right first time), schedule adherence, and productivity improvements.Support manufacturing investigations , support and manage change controls, and maintain permanent… 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)
- …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
- AUROBINDO (Durham, NC)
- …internal workshops or sourcing external training providers.Additional ResponsibilitiesEnsure compliance with company policies and federal, state, and local ... with expertise in manufacturing, R&D, Quality Assurance and Quality control and regulatory affairs. In addition to several formulations under manufacture, we have a… more
- Merck & Co. (Durham, NC)
- …- Knowledge of lean principles, equipment design, and preventative maintenance.- Regulatory - Global regulations and compliance requirements governing ... establishing a strong business partnership and ensuring excellence in Compliance , Supply, Continuous Improvement, and Cost Management.--The Associate Director,… 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
- TD Bank Group (Mount Laurel, NJ)
- …requires the ability to lead, train and mentor teams in conducting thorough investigations , ensuring regulatory compliance , and maintaining high standards of ... may include HR, Technology, Finance, Risk Management Ensures team operates in compliance with applicable internal and external requirements, and employees comply… 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
- 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 ... external sources and services; involving physical inspection, documenting dimensional compliance and review of vendor certifications for compliance . This… more
- Holland & Knight LLP (Tampa, FL)
- …in any of our US offices. General Description: We are seeking a Privacy and Compliance Analyst to join our team. The Privacy and Compliance Analyst will support ... an understanding and experience with data protection and privacy laws, compliance functions, clients and third-party risk assessments, and research evaluation. Key… 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....proposed and new rules in addition to market and internal developments and provide advice and guidance on the… more
- The Christ Hospital (Cincinnati, OH)
- …audits, investigations and reviews, making recommendations to management on internal control and process effectiveness. The Compliance Auditor maintains ... databases, and maintains organized work paper files. Leads privacy violation investigations and documents findings for potential regulatory reporting.… more
- Miltenyi Biotec (San Diego, CA)
- …small-team environment, the Healthcare Compliance Officer will also oversee internal investigations , support training and monitoring activities, and serve as ... processes and compliance with applicable state and federal reporting obligations. Internal Investigations , Auditing, and Risk Management Lead or support … more
