- Repligen (Waltham, MA)
- …of 10 years of experience in a cGMP, ISO 9001, or ISO 13485 Quality Management System environment required.Minimum 5-8 years of experience mentoring and ... and release including deviation support, root cause analysis, customer complaint management , hosting customer/regulatory audits and Certificate of Quality … more
- Merck & Co. (Durham, NC)
- …individual and has the ability to communicate effectively with senior management on complex technical issues and manage multiple high-priority, complex ... environmental, health, safety, and sustainability (EHS&S) opportunities.- Ensure comprehensive change management of all EHS and Site initiatives to ensure ongoing… more
- Merck & Co. (Rahway, NJ)
- …policy.- The role will also be responsible for proactive resourcing planning, risk assessment strategies and budget management as necessary. The candidate ... an inspiring mission to achieve new milestones in global healthcare . The Biologics and Biopharmaceutics team is responsible for.../ our Research & Development Division ) such as Quality , Regulatory CMC, and technical functions, to ensure timebound… 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 ... proficiency in ISO 13485, ISO 14971-2019, and other relevant quality management systems.Qualifications:Bachelor's degree in Mechanical Engineering, Biomedical… more
- Merck & Co. (Rahway, NJ)
- … Management , Portfolio Management , Project Management , Project Portfolio Management (PPM), Project Risks, Risk Management {+ 5 more}-Preferred ... with key partner organizations such as clinical development, regulatory, quality and other supply chain areas to address clinical...company marketed products . - Analyzes and anticipates project risk s as they relate to clinical supply chain… more
- Merck & Co. (Rahway, NJ)
- …Management , Cross-Functional Team Leadership, Data Analysis, Detail-Oriented, Financial Risk Management (FRM), Good Manufacturing Practices (GMP), ... Planning (MRP), Portfolio Management , Project Management , Project Portfolio Management (PPM), Project Risks, Risk Management {+ 5 more}-Preferred… more
- Merck & Co. (Rahway, NJ)
- …Project Management , Project Portfolio Management (PPM), Publications Management , Regulatory Compliance, Risk Management , Sourcing and Procurement, ... a lead GCS Planning program representative ) such as clinical development, regulatory, quality and other supply chain areas to negotiate timelines ,- strategies and… more
- Merck & Co. (Durham, NC)
- …Overview Our company in the United States and Canada, is a global healthcare leader with a diversified portfolio of prescription medicines, vaccines, and animal ... momentum, and an inspiring mission to achieve new milestones in global healthcare . Our Manufacturing Division is a team of dedicated, energetic individuals committed… more
- Merck & Co. (Rahway, NJ)
- …Staff, Performance Monitoring, Personal Initiative, Project Scheduling, Resource Allocation, Risk Management , Stakeholder Management , Vision ... teams, partner functions including Global Science Engineering and Commercialization (GSEC), Quality , and CMC Regulatory Affairs, as well as, the GBO Leadership… more
- Merck & Co. (Rahway, NJ)
- …manufacturing. -The candidate will provide scientific expertise by learning and utilizing Quality Risk Management methodologies and tools for statistical ... The scientist will be expected to exhibit a mindset of safety and quality compliance, which will include following current Good Manufacturing Practices (cGMPs), and… more
- Kelsey-Seybold Clinic (Pearland, TX)
- …or ambulatory setting. Preferred: Experience working in the fields of healthcare quality , patient safety, and/or risk management . Experience working with ... Job Description Responsibilities Sr. Healthcare Quality Specialist RN is responsible for evaluating and improving quality of care and patient safety at… more
- Merck & Co. (San Francisco, CA)
- … Process, Managing Engineering Teams, Operational Metrics, Performance Monitoring, Project Management , Research Databases, Risk Management , Status Reporting, ... with the DSCS Digital Leadership Team to drive the execution and management of DSCS Digital initiatives.Development Sciences and Clinical Supply (DSCS) enables Drug… 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 ... accelerate process and product development and manufacturing and ensure safety and quality of our products. The successful candidate will be accountable for… more
- Merck & Co. (Rahway, NJ)
- …Making, Detail-Oriented, Maintenance Supervision, Manufacturing Process Validation, Manufacturing Quality Control, Manufacturing Scale-Up, People Management , ... toCoordinate project planning, resourcing, progress reporting, troubleshooting and people management .Serve as the scientific/technical mentor for junior staff.- Provide… more
- Merck & Co. (Rahway, NJ)
- …on regulatory obligations, compliance requirements and company strategy.Providing quality advice to stakeholders creating optimal development, commercialization, and ... and Women's Health programs. Prioritizes and oversees execution of high quality and timely health authority engagement in attaining desired results. Reviews… more
- Merck & Co. (Upper Gwynedd, PA)
- …including assessment of the probability of regulatory success together with risk mitigation measures.-Lead development and execution of global product and project ... acceptability and identification of potential risks.Lead the development, communication, lifecycle management and review of the CMC Regulatory Strategy Document for… more
- Merck & Co. (Rahway, NJ)
- …(SORs) to promote fast and efficient closure.As needed, safely perform High Risk Work involving hazardous energy control.Identify and follow through on opportunities ... comprehensive package of benefits.- Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …GxP group and its partners as applicable ensuring the execution of a risk -based audit program and effective CAPA management resulting from audits, health ... of GxP audits assigned in alignment with the Master Audit Schedule, using a risk -based approach to ensure the Audit Plans are aligned with the company's strategy and… more
- Merck & Co. (Rahway, NJ)
- … Management , Pharmaceutical Process Development, Process Scale Up, Program Risk Management , Project Planning, Protein Characterization {+ 2 more}-Preferred ... and downstream processes that produce high yields along with superior product quality and allow speedy progression for clinical studies and commercial launch. The… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …with strategic alignment.Effective in fast-paced environments with a focus on quality and documentation.Skilled in change management and guiding teams ... and propel data-driven decision-making.Promotes a culture of creativity and risk -taking, alongside developing processes that encourage experimentation and innovative… more
