- Insmed Incorporated (NJ)
- …seeking an experienced leader to oversee cybersecurity operations, enterprise risk management , and Computer Systems Validation (CSV) program . This role will ... to Executive Management and Boards of Directors .Strong understanding of risk management , compliance , and audit processes within regulated industries,… more
- Lundbeck (North Hyde, SD)
- …Provide support and consultancy to the company and the Management Team on compliance issues, legal matters, risk management and currently applicable and ... on the development and implementation of an effective regional Compliance Program in Australia and New Zealand...(identification of training needs, employee training). Risk management : proactively map and identify compliance and… 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...key digital systems. This role drives the ITGC audit program , advises on risk mitigation strategies, and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …vendors/consultants. Essential Functions Supports the Director in raising awareness of the Compliance program and fostering accountability for compliance ... reporting or departmental operational impact as assigned Responsible for ensuring that Compliance senior management is informed of compliance issues… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- … Compliance will be responsible for providing quality oversight over the compliance program within the global quality organization to ensure harmonization, ... alignment across all functions and sites.Support the development of the GMP Compliance program related to clinical/ commercial stage and manufacturing.Support… more
- Merck & Co. (Ames, IA)
- …Quality Management (SQM) and Animal Health global auditing program :ResponsibilitiesPerform comprehensive and detailed GMP compliance audits of animal ... and be decisive in an ambiguous environment.Experience and ability to achieve compliance goals through a risk -based approach with a deep understanding… more
- Merck & Co. (Durham, NC)
- …Leadership, Networking and Partnerships, Program Management , Quality Management Systems (QMS), Quality Strategy, Regulatory Compliance , Risk ... across the full value chain for a late-stage ophthalmic program . In this role, you'll be a core member...you'll be a core member of the Value Chain Management Team, guiding strategy, ensuring compliance , and… 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 ... and clinical studies. Collaborate with cross-functional teams (Clinical Development, Regulatory, Program Management , etc.) to shape and refine Clinical… more
- Insmed Incorporated (NJ)
- …Health & Safety (EH&S), the individual will lead the development, implementation, and management of a company-wide EH&S program that encompasses both lab ... management systems, including documentation, standard operating procedures (SOPs), risk assessments, incident investigation protocols, reporting and emergency response… more
- Merck & Co. (Rahway, NJ)
- …goals, and quality and regulatory compliance .Essential Duties and Responsibilities: Program Leadership and Technical Project Management :Provide program ... extensive experience in design controls, device transfer, control strategies device risk management , and design verification testing to developvalue-added… more
- Merck & Co. (Rahway, NJ)
- …product development, such as manufacturing process development and validation, design control, risk management , material and molding, design validation to create ... with design verification, including but not limited to, design controls, risk management , materials & molding, process development and validation,… 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …teams.Ensure consistent and proactive representation of Quality at all stages of the program management process.May Interact with management at all levels ... with Medical Affairs to facilitate the implementation of a risk -based quality management process fully embedded through...to conduct quality reviews of product profiles, ensuring thorough management review of all quality and compliance … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Manager, Employee Relations, is pivotal in ensuring consistent and thorough management of Employee Relations processes (including corrective action) across the ... business areas of support. They are responsible for consulting with management on best practices for coaching, performance and behavioral concerns while ensuring… more
- Insmed Incorporated (NJ)
- …particular focus on orphan diseasesExcellent communication skills (verbal and written) and program management skillsHighly organized with a strong attention to ... years of direct pharmaceutical experience in patient services3+ years of program operations management experience3+ years of people leadershipRare and/or… more
- Merck & Co. (Rahway, NJ)
- …Intelligence (BI) Desktop, Natural Language Processing (NLP), Python (Programming Language), Risk Management , R Programming, Science, Scientific Literacy, Trade ... to support the R&D efforts related to the Insider Risk /Trade Secret (IR/TS) program through advanced data...and findings to stakeholders at various levels, including senior management Collaborate with team members to define key metrics… more
- Formation Bio (New York, NY)
- …you will have the opportunity to establish the strategic development and operational management of Formation Bio's quality assurance program to support the ... regulatory requirements, including GMP, GCP, and ICH guidelines. Expertise in Quality Management Systems (QMS). Extensive knowledge of quality risk assessment… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …stakeholders to execute audits effectively. Ensure the internal systems auditing program fulfills regulatory requirements performs audits, identifies compliance ... and inspections and execute against these metrics consistently. Provide inspection management support regarding compliance concerns identified during internal… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Real Estate; Digital, Data and IT; Finance and Tax) and complex and high- risk supplier contracting. Relationships This job reports to the Managing Assistant General ... contracting and recommend best practices and solutions Proactively conduct comprehensive risk assessments to identify potential legal and operational risks within… more
- Merck & Co. (Boston, MA)
- …strategy development, strategy execution and value realization, enterprise strategic planning, risk management , and strategic venture investments in healthcare ... Consulting, Collaborating, Communication, Data-Driven Decision Making, Influencing Skills, Leadership, Management Consulting, Oncology, Prioritization, Risk Management… more
