- Repligen (Waltham, MA)
- …desirable.Experience:A minimum of 10 years of progressive experience in internal controls, SOX compliance , or related regulatory compliance roles within a ... OverviewRepligen Corporation is seeking a dynamic Controls & SOX Compliance leader. This is a high-impact, strategic role driving...strategy across a global company Lead SOX risk assessments, audits , and remediation efforts Partner with senior … more
- Merck & Co. (Rahway, NJ)
- …10%Flexible Work Arrangements:HybridShift:Not IndicatedValid Driving License:NoHazardous Material(s):n/aRequired Skills: Audits Compliance , Audits ... Trade Finance, International Trade Law, Investigative Skills, IS Audit, Legal Regulatory Compliance , Metrics Analysis, Problem Solving, Process Improvements,… more
- Merck & Co. (Rahway, NJ)
- …10%Flexible Work Arrangements:HybridShift:Not IndicatedValid Driving License:NoHazardous Material(s):n/aRequired Skills: Audits Compliance , Audits ... Trade Finance, International Trade Law, Investigative Skills, IS Audit, Legal Regulatory Compliance , Metrics Analysis, Process Improvements, Project Management,… more
- Merck & Co. (Millsboro, DE)
- …environment in compliance with local, state, and federal regulations. The Sr . Specalist of Biosafety will collaborate with various departments to promote best ... Job DescriptionSr. Specialist, Biosafety The Sr . Specialist of Biosafety is accountable for providing and managing an efficient and effective Biosafety program at… more
- Merck & Co. (Durham, NC)
- …querying), DeltaV SIS Experience working with Information Technology teams. Experience with regulatory audits and working knowledge of data integrity principles. ... of process control, data collection techniques, and troubleshooting in compliance with SDLC, GMP, safety, and environmental regulations.- Actively support,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Liaise with Audit and Compliance team to ensure that Global Medical Affairs audits are properly planned, communicated and that audit targets for MA audits ... Safety and PharmacovigilanceR&DVendors/ CROs/ third partiesHEOR/ RWEEpidemiology Legal and compliance Marketing/ commercialGMP QA/ Supply chain / Regulatory … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …regulations related to computerized systems, including GxP (GCP/GVL/GCLP/GLP).Collaborate with the Audits Compliance (RDPVMA) team to determine relevant audit ... for validation and qualification of IT services.In collaboration with Audits Compliance team, determine relevant audit targets...to RD PV QA on quality assurance practices and regulatory compliance .Keep abreast of evolving regulations and… more
- Tris Pharma (Monmouth Junction, NJ)
- …but not limited to: investigative processes, CAPAs and CPIs, etc.Participates in regulatory agency inspections and customer audits , as needed; Performs and/or ... New Jersey, Tris has an immediate opening for a SR . Manager or Manager, Quality Management Systems (QMS). Title...systems thinking and a holistic systems-based approach to drive compliance and assess operational needs and activities in to… more
- Eisai, Inc (NJ)
- …activities relating to clinical study Trial Master Files (TMF), ensuring regulatory inspection-readiness and compliance with applicable laws and regulations. ... your profile, we want to hear from you. The Sr . Manager is to lead collaboration efforts with RandD...and transformation initiative and is compliant with ICH-GCP and regulatory requirements. This role also provides direction, leadership and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …while ensuring alignment with the Global Digital Transformation (DX) strategy, regulatory compliance framework, and overall quality assurance standards. This ... excellence.Oversee global project budgets to ensure cost-effective solutions that meet compliance and technical standards; drive vendor assessments, audits , and… more
