- Merck & Co. (Rahway, NJ)
- …set tactical and strategic direction on programs to ensure delivery of high- quality products, test methods, and robust manufacturing processes for both clinical and ... particularly in the design, manufacturing, verification, validation and associated quality and regulatory aspects of combination products.The incumbent must be… more
- Repligen (Hopkinton, IA)
- …the work area is clean and organized.Ensure production goals, schedules, and quality standards are met.Train, coach, and mentor production team members.Monitor ... OverviewThe Manufacturing Line Lead 2nd Shift reports to the Production Manager...a key role in ensuring that the department's safety, quality , and production goals are met.ResponsibilitiesSupervise and coordinate the… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Patient Safety standards and processes as applicable Function as a Quality Point of Contact /resource promoting knowledge and information sharing to improve the ... find better and more innovative ways to improve their quality of life. We're changing lives for a living....chain and customer focus. This role enables and ensures compliance against health authority regulations and Novo Nordisk requirements… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …ensuring highest quality to patients. This role enables and ensures compliance against health authority regulations and Novo Nordisk requirements in relation to ... applicable Develops comprehensive, relevant resources (eg training program, FAQs) to enable compliance with quality control process requirements across NNI and… more
- BioAgilytix (Durham, NC)
- …with hands-on responsibility for data quality , access control, and compliance protocols.Define standards , build quality assurance processes, and ... and keep BioAgilytix ahead of regulatory requirements.Key ResponsibilitiesData Governance & Quality Standards :Develop a foundational data governance framework,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and regulated applications meet strict regulatory requirements, industry best practices, and internal quality standards . The Lead is responsible for defining ... Transformation (DX) strategy, regulatory compliance framework, and overall quality assurance standards . This role collaborates with cross-functional Global… more
- Insmed Incorporated (San Diego, CA)
- …managing quality and regulatory compliance related to GCPs, acts as quality lead on the gene therapy clinical development team, and collaborates on other ... direction with cross functional working groups to identify and mitigate GCP quality and compliance issues.Supports the evaluation and acceptability of vendors… more
- Novo Nordisk Inc. (Durham, NC)
- …improvement, & project management Serve as the Lead and SME to operate within compliance with a quality mindset that focuses on risk management & mitigation ... initiatives & projects Lead the team's Change Management standards and always manage assignments within compliance with a Quality Mindset that focuses on… more
- Merck & Co. (Rahway, NJ)
- …launch in alignment with the company's business goals, and quality and regulatory compliance .-Essential Duties and Responsibilities:Strategic Leadership ... technology transfer programs in both development and lifecycle management, ensuring compliance with relevant regulatory standards .Ensure robust technical plans,… more
- Merck & Co. (Durham, NC)
- …and leadership skills to empower teams, solve complex technical challenges, and ensure compliance with industry standards while making a tangible impact on our ... make our products. We work in the manufacturing plants with a "Safety First, Quality Always" mindset striving for continuous improvement. We work in the local plant… more
- Merck & Co. (Rahway, NJ)
- …ResponsibilitiesLead/contribute to device development, design controls for the assigned projects. Lead the implementation and/or ensure effective execution of the ... Device Development and with external suppliers.Understand and apply regulatory / compliance requirements relative to design controls and risk management activities.… more
- Aequor (Thousand Oaks, CA)
- …Engaging with Quality and Regulatory teams to ensure alignment and compliance across the network and with various agency submissions while delivering NPI ... management when appropriate. Reviewing protocols for manufacturing activities and partnering with Quality Assurance to ensure that GMP standards are maintained… more
- Twist BioScience (South San Francisco, CA)
- …cGMP, GLP), FDA 21 CFR Part 11, Eudralex Annex 11, and internal quality standards . Oversee and execute comprehensive computer system validation (CSV) activities, ... analytics, and data visualization capabilities to support operational decision-making and quality reviews. Compliance & Validation: Ensure our custom MES… more
- Merck & Co. (Durham, NC)
- …Carolina.- The Durham EHS Lead influences site leadership ensuring compliance with regulatory requirements, corporate standards , policies, and procedures ... compliance with local, state and federal legislation, Company standards and industry best practices, investigate and mitigate risks across environmental,… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition Summary:The Payments Manager will help lead the strategic direction, operational quality , and innovation of the credit union's payments ... role in driving member satisfaction, improving efficiencies, and ensuring regulatory compliance while advancing the credit union's payments strategy in alignment… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …focused on an EHS first mindset, a Right First Time culture of quality , permanent inspection readiness compliance mindset and passionately drives continuous ... internal audits of the facilityPartner and manage relationships with contractors to ensure quality of work and compliance with all company policies and… more
- Merck & Co. (Rahway, NJ)
- …systems and other strategies that-optimize-statistical efficiency and quality .Develop and-maintain-Site Facility Energy Regression models.Work with Operations ... Process/Equipment Trending, Dashboards, and managing KPI's & Metrics.Proven ability to lead projects, developing teams, and building team self-sufficiency.3 years of… more
- Merck & Co. (North Wales, PA)
- …clinical/scientific execution of clinical protocol(s). This may include:Serving as the lead clinical scientist on the clinical trial team.Leading medical monitoring ... Data Management/Programming.Collaborating cross-functionally to monitor clinical data to ensure quality , completeness, and integrity of trial conduct.Providing tactical/scientific mentorship… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …project execution and deliverables. Oversees or initiates RBQM operating procedures and standards ; monitors and enforces compliance of standard procedures and ... leverages external expertise in supporting RBQM activities.- Technical: Provides technical guidance in Quality by Design. Lead the team to define Critical to … more
- Merck & Co. (Rahway, NJ)
- …with working closely with the group Director to define group strategy and to lead a team of scientists in solving complex analytical problems at the interface of ... in integrated analytical control strategy development and execution. Demonstrated ability to lead a technical team and develop talent through good mentoring skills.… more
