- Repligen (Waltham, MA)
- … risk assessments, documentation, testing, remediation, and reporting.Collaborate with senior management and cross-functional teams (Finance, IT, Legal, ... -related activities are documented, tracked, and aligned with the company's overall risk management strategy.Evaluate and implement new tools, technologies, and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Collaboration:Facilitate effective communication and collaboration with internal stakeholders, including IT and Compliance Risk Management as well as Global ... areas centered around rare diseases and immune disorders. SummaryThe Sr . Director, Data Quality and Integrity (Global R&D &...culture of compliance and accountability in data management practices. The position also involves risk -based… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and mitigate identified ethics and compliance risks as part of NNI's risk management program. This role leverages innovative technology, data analytics and ... Identify, evaluate, and implement technology and data analytics solutions that enhance compliance monitoring, reporting, and risk management Utilize data… more
- Merck & Co. (Rahway, NJ)
- …License:NoHazardous Material(s):n/aRequired Skills:Audits Compliance , Audits Compliance , Compliance Program Development, Currency Risk Management , ... International Trade Law, Investigative Skills, IS Audit, Legal Regulatory Compliance , Metrics Analysis, Process Improvements, Project Management , Project… more
- Merck & Co. (Rahway, NJ)
- …extensive experience in design controls, device transfer, control strategies, device risk management , and design verification testing to develop value-added ... Job DescriptionJob Summary: - Sr . Engineer, Device Technology is a key engineering...devices or combination products in both development and lifecycle management , ensuring compliance with relevant regulatory standards.Use… more
- Merck & Co. (Rahway, NJ)
- …Operations, Clinical Research, Clinical Study Design, Clinical Testing, Clinical Trial Compliance , Clinical Trial Management , Critical Thinking, Data Analysis, ... Development, Ethical Standards, Health Literacy, ICH GCP Guidelines, Informed Consent, Management Process, Manufacturing Compliance , Medical Writing, Motivation … more
- Merck & Co. (Rahway, NJ)
- …devices and combination products globally.- Experience in design controls, device risk management , medical device, complex combination product kits, prefilled ... picture, and how activities link to our Company strategy and business goals- Utilize device risk management tools to build device or combination product risk … 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...of federal, state, and local biosafety regulations, and advise management accordingly.Review risk assessments for biological materials… more
- Merck & Co. (Rahway, NJ)
- …effectively communicate with stakeholders at various levels, including cross-functional teams, senior management , external vendors, and clinical sites. Strong ... Management , Cross-Functional Team Leadership, Data Analysis, Detail-Oriented, Financial Risk Management (FRM), Good Manufacturing Practices (GMP),… more
- Merck & Co. (Rahway, NJ)
- …effectively communicate with stakeholders at various levels, including cross-functional teams, senior management , external vendors, and clinical sites. Strong ... develops mitigation strategies for review with clinical partners and senior leaders.--Works directly in the SAP system to establish... Management , Project Management , Project Portfolio Management (PPM), Project Risks, Risk Management… more
- Merck & Co. (Rahway, NJ)
- … Compliance , Metrics Analysis, Problem Solving, Process Improvements, Project Management , Project Risk Assessments, Regulatory Affairs Management , ... IndicatedValid Driving License:NoHazardous Material(s):n/aRequired Skills:Audits Compliance , Audits Compliance , Compliance Program Development, Crisis Management… more
- Merck & Co. (Rahway, NJ)
- …programs.Technical scope:Direct projects focusing on cell bank process risk assessments, documentation, process characterization, technology transfer and ... timelines, in a right-first-time manner, with a "safety first, compliance always" mindset.-Minimum Required Education and Experience:-Bachelor's Degree in… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …proactively represented at program level and support proactive quality risk management process.Interact with the audit and compliance function for the ... of MA risks identified through audits, inspections, internal meetings, remediation and risk management in close collaboration with the organization's quality … more
- Merck & Co. (Rahway, NJ)
- …(RaDS-IT. We are responsible for developing and applying techniques for quantitative cost- risk -benefit analysis of complex scenarios in R&D. We deeply engage with ... consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los Angeles Residents… more
- Merck & Co. (Rahway, NJ)
- …, Project Portfolio Management (PPM), Publications Management , Regulatory Compliance , Risk Management , Sourcing and Procurement, Strategic Planning ... effectively communicate with stakeholders at various levels, including cross-functional teams, senior management , external vendors, and clinical sites. Strong… more
- Tris Pharma (Monmouth Junction, NJ)
- …implement improvements, including CAPAs and CPIs, across departments as appropriateApplies quality risk management principles in design (and resolution) of key ... New Jersey, Tris has an immediate opening for a SR . Manager or Manager, Quality Management Systems...systems thinking and a holistic systems-based approach to drive compliance and assess operational needs and activities in to… more
- Merck & Co. (Durham, NC)
- … goals through a risk -based approach (Safety Regulations, Quality Assurance, Risk Management , Deviation Management , Product Release, Change Control).- ... for establishing a strong business partnership and ensuring excellence in Compliance , Supply, Continuous Improvement, and Cost Management .--The Associate… more
- Aequor (Devers, TX)
- Job Title: Environmental, Health and Safety Senior Specialist Location: Devens, MA ID: 62636-1 Duration: 12 Months Work Schedule: Please refer to the attached work ... with Contractor Safety, Safe Work Permit Program Support EHS training and Risk /Hazard Assessment Initiative/autonomy EHS audits / Field Audits and Inspections EHS… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …requires skills in working in a fast-paced environment, continuous improvement, change management , and risk management . Experience working and managing ... as other research areas centered around rare diseases and immune disorders. Summary: The Senior Director, Head of RBQM ( Risk Based Quality Monitoring) sets the… more
- Merck & Co. (Rahway, NJ)
- …to join Biologics Process Research & Development (BPR&D) as a Senior Principal Scientist.BPR&D within Research Laboratories is committed to rapidly delivering ... and engage with the scientific community to influence the field.As a Senior Principal Scientist, you will drive various strategic initiatives and translate… more
