- Formation Bio (New York, NY)
- …health authority audits.Responsibilities Develop, implement, and maintain the pharmaceutical quality management system (QMS) to ensure compliance with regulatory ... and implement corrective and preventive actions (CAPAs) effectively. Proficiency in quality management tools and methodologies (eg, risk assessment, root cause… more
- Merck & Co. (Rahway, NJ)
- …in line with the global strategy, including but not limited to overall supplier management , compliance , risk management , diversity spend, and stakeholder ... will be required to provide primary expertise in Capital planning, engagement management and performance improvement of the capital spend, and ensure complete… more
- Merck & Co. (Rahway, NJ)
- …areas of the enterprise. Areas included, but not limited to are, overall supplier management , compliance , risk management , diversity spend, and ... directed.-In addition to providing primary expertise in Capital planning, engagement management and performance improvement the senior specialist will provide direct… more
- Formation Bio (New York, NY)
- …change management , and vendor oversight. The Sr. Director ensures compliance with cGMP standards, oversees QA activities at CDMOs, performs critical ... and implement corrective and preventive actions (CAPA effectively. Proficiency in quality management tools and methodologies (eg, risk assessment, root cause… more
- Merck & Co. (Rahway, NJ)
- …stakeholders at all levels, ensuring their commitment to the technical transfer vision. Risk Management , Compliance Oversight & Decision Making:Lead the ... rigorous technical support processes to support manufacturing sites, proactive risk management , performance monitoring, and continuous improvement.-Experience… more
- Genmab (Plainsboro, NJ)
- …policies; and (ii) the implementation and oversight of Genmab's third-party privacy risk compliance function. Successful candidates will have a deep ... the implementation of technical rules and standards for privacy compliance in data life cycles and deployment of technologies...oversight of Genmab data processors in accordance with Genmab's risk management framework and data privacy and… more
- Genmab (Plainsboro, NJ)
- …and CROs to oversee sponsor oversight visits and ensure quality and compliance across all activities.Site Selection and Management Collaborate with the ... and completeness of the eTMF, supporting inspection readiness and regulatory compliance .Maintain relevant sections in Clinical Trial Management Systems and… more
- Merck & Co. (Rahway, NJ)
- …country program rollout with cross divisional and market stakeholdersStrategic thinking, risk management , and roadmap planning for data product evolutionEnsure ... premier "Data First" commercial biopharma organization.In this Associate Director Data Product Management role, you will be part of the HHDDA Commercial Data… more
- Tris Pharma (Monmouth Junction, NJ)
- …implement improvements, including CAPAs and CPIs, across departments as appropriateApplies quality risk management principles in the design (and resolution) of ... New Jersey, Tris has an immediate opening for a Manager, Quality Management Systems (QMS). Summary:The Manager, Quality Management Systems (QMS) supports,… more
- Merck & Co. (Rahway, NJ)
- …devices and combination products globally.- Experience in design controls, device risk management , medical device, complex combination product kits, prefilled ... and local site procedures for safety, quality, and regulatory compliance - Understand the big picture, and how activities link...to our Company strategy and business goals- Utilize device risk management tools to build device or… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …completed in compliance and meets Novo Nordisk's business standards Risk Management : Assessing and mitigating risks associated with operations, implementing ... to make a difference? The Position Drive portfolio strategy and study management activities and manage cross-functional study team, external service providers (CROs,… more
- Merck & Co. (Rahway, NJ)
- …with understanding of Design Controls (21 CFR 820.30)Familiarity with the following standards: Quality Management - ISO 13485, Risk Management - ISO 14971, ... cross-functional understanding and to support project timelines.Development experience in risk -oriented, regulated environmentsDevelopment project leadership with a proven track… more
- Merck & Co. (Rahway, NJ)
- …with understanding of Design Controls (21 CFR 820.30)Familiarity with the following standards: Quality Management - ISO 13485, Risk Management - ISO 14971, ... cross-functional understanding and to support project timelines.Development experience in risk -oriented, regulated environmentsDevelopment project leadership with a proven track… more
- Merck & Co. (Rahway, NJ)
- …Associate Director, Safety Programs CoE.- This individual will be responsible for the management of a portfolio of corporate safety programs that may include High ... Risk Work, Fire & Life Safety and other similar...manage company's safety standards and technical guidelines to ensure compliance and reduction in workplace safety risks.Lead global continuous… more
- Tris Pharma (Monmouth Junction, NJ)
- …Leadership team including insights on financial performance, capital allocation, and risk management ; Directs cost monitoring and reporting activities; Drives ... In depth knowledge of corporate financial law, compliant financial reporting and risk management practices Excellent knowledge of data analysis and forecasting… more
- Merck & Co. (Rahway, NJ)
- …products and non-our company marketed products . - Analyzes and anticipates project risk s as they relate to clinical supply chain deliverables and prepares , ... Demonstrates high capability to solve unstructured problems, make informed risk decisions considering both technical & business risks, &...At least 5 year s of experience in project management - - At least 5 years of experience in… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …new ideas, solutions, methods or opportunities; foster innovation through appropriate risk -taking and experimentation to ensure that the Medical Promotional Review ... product labeling committees and other department projects/initiatives Demonstrates the people management skills needed to lead direct reports and working teams;… more
- Merck & Co. (Rahway, NJ)
- …talent Development.-The role will also be responsible for proactive resourcing planning, risk assessment strategies and budget management as necessary (including ... The successful candidate will be accountable for proactive resourcing planning, risk assessment strategies and will focus on talent development and partnering… more
- Merck & Co. (Rahway, NJ)
- …manufacturing process development, qualification, and validation; and design control and risk management techniques to positively support and influence clinical ... engineering design, engineering analysis and testing, medical device design controls, risk management , test method/fixture development, design verification and… more
- Merck & Co. (Rahway, NJ)
- …with understanding of Design Controls (21 CFR 820.30)Familiarity with the following standards: Quality Management - ISO 13485, Risk Management - ISO 14971, ... in layman's terms to facilitate cross-functional understanding.Development experience in risk -oriented, regulated environmentsDevelopment project leadership with a proven track… more
