- Insmed Incorporated (NJ)
- …to Executive Management and Boards of Directors .Strong understanding of risk management , compliance , and audit processes within regulated industries, ... We are seeking an experienced leader to oversee cybersecurity operations, enterprise risk management , and Computer Systems Validation (CSV) program. This role… more
- Merck & Co. (Durham, NC)
- …Management Systems (QMS), Quality Metrics, Quality Risk Assessment, Quality Risk Management , Regulatory Compliance Consulting {+ 5 more}Preferred ... motivate, develop and mentor other auditors Knowledge of and experience in Quality Risk Management methods Knowledge of US and European cGMP guidelines, ICH… more
- Merck & Co. (Omaha, NE)
- …and others in continuously improving our Company Animal Health trade compliance risk level. Education Requirements: High school diploma required.Bachelor's ... collaborating with the GTC Center of Excellence (COE) and Global Trade Management (GTM) when necessary.Develop and update trade compliance training materials… more
- Repligen (Waltham, MA)
- …years of hands-on experience in IT Audit, ITGC, or IT Risk Management within a public or large-scale company.Deep understanding ... are seeking an experienced IT Manager, SOX & ITGC Compliance to lead the design, implementation, and ongoing effectiveness...This role drives the ITGC audit program, advises on risk mitigation strategies, and partners closely with Internal Audit,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …External Quality and other internal functions to understand and mitigate any compliance risk and establish vendor quality scorecard.Support development and ... an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Head of Compliance as part of the Global Quality team based in Raritan, NJ. Role… more
- Insmed Incorporated (NJ)
- …the Senior Director will be responsible, globally, for implementing the safety and risk management activities for clinical development; be responsible for safety ... surveillance, risk management , and risk communication...for assigned products.Lead the identification of risks and appropriate risk minimization and pharmacovigilance measures in compliance … more
- Merck & Co. (Rahway, NJ)
- …exploring alternative ways to view and solve problems to achieve results Drive proactive risk management activities, including risk assessment, risk ... thermal and distribution qualification for pharmaceutical products.Strong understanding of risk management principles.Strong strategic and analytical thinking,… more
- AdaptHealth LLC (Philadelphia, PA)
- …This role evaluates the adequacy and effectiveness of internal controls, risk management processes, and governance frameworks to ensure organizational ... and operational efficiency. Key responsibilities include supporting Sarbanes-Oxley (SOX) compliance activities, conducting risk -based audits, and contributing to… more
- Eisai, Inc (Nutley, NJ)
- …Drafting and Negotiation, Industry/ Regulatory Knowledge, Legal & Reputational Risk Management , Legal Knowledge, Mentoring/ People Development, Stakeholder ... enable the Company's innovation while protecting data and mitigating risk . The role requires deep expertise in privacy law,... Management (Legal/ Compliance )Eisai Salary Transparency Language:The annual base salary range for… more
- Merck & Co. (Rahway, NJ)
- …/ compliance requirements relative to design controls and risk management activities. Position Qualifications: Education Minimum Requirement: BA/BS ... and supporting continuous improvement initiatives related to design control and risk management processes for combination products. This includes identifying… more
- Merck & Co. (Rahway, NJ)
- …drug product, finished goods including combination products, and samples. Drive proactive risk management activities, including risk assessment, risk ... and external stakeholders. Required Skills: Biopharmaceutics, Biopharmaceutics, Business, Change Management , Combination Products, Compliance Packaging, Cross-Cultural Awareness,… more
- Formation Bio (New York, NY)
- …with ICH-GCP, FDA regulations, and other applicable regulatory standards. Champion proactive risk management by identifying and mitigating risks before they ... faster and more efficiently.About the PositionThe Director of Clinical Project Management will provide overall leadership and strategic direction for the clinical… more
- Merck & Co. (Rahway, NJ)
- …for new product introductions and technology transfers across the network.Drive proactive risk management activities, including risk assessment, risk ... Process, Manufacturing Scale-Up, Mentorship, Packaging Engineering, Process Optimization, Risk Management , Root Cause Analysis (RCA), Social Collaboration,… more
- Insmed Incorporated (NJ)
- … systems, including documentation, standard operating procedures (SOPs), risk assessments, incident investigation protocols, reporting and emergency response ... for creating and implementing programs that ensure workplace safety, regulatory compliance , and environmental protection for all Insmed locations.Key duties include … more
- Eisai, Inc (NJ)
- …and mitigate risks.Process Management Supports functional strategy execution and risk management initiativesDepartmental Subject Matter Expert (SME) and may ... and minimize risk .Manages vendor qualification processes and partner with Vendor Risk Assessment teams to ensure compliance with regulatory requirements and… more
- Cipla (Central Islip, NY)
- …manner to ensure avoidance of all actual and potential conflicts of interest Risk management Minimize impact of supplier shortages by proactively identifying and ... relationships, negotiating favorable contracts, identifying cost-saving opportunities, and maintaining compliance with regulatory and company policies. Success in this… more
- ValSource, Inc. (Rahway, NJ)
- …projects simultaneously. Strong understanding of EPCMV, Quality by Design and risk -and science-based approaches for compliance are desired. Experience with ... identify experienced and technically skilled leaders with Project Lead and Project Management experience to support a variety of exciting projects with our clients… more
- Sunrise Senior Living (Bethesda, MD)
- …* Partner with the community leadership team to promote resident safety and compliance with Risk Management national/provincial regulations pertaining to ... for oversight and implementation of all Care programs, regulatory compliance , recruiting, and performance management . RESPONSIBILITIES & QUALIFICATIONS… more
- Cipla (Fall River, MA)
- …member of the InvaGen Pharmaceuticals Plant Quality Team. This role ensures compliance with both internal and external quality standards at Invagen Pharmaceuticals ... remains compliant with all regulatory requirements (eg, FDA, ICH, EMA). Support risk assessments and help mitigate any potential quality risks to product safety… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …file is complete and accurate for assigned stud(ies).-Ensure that a study level operational risk management plan is in-place and applies a smart- risk taking ... trial delivery, including but not limited to issue resolution, risk mitigation and escalation to Global Project Team (GPT),...philosophy-Responsible for the delivery, oversight, performance and management of 3rd party vendors to ensure … more
