- Merck & Co. (Rahway, NJ)
- …and apply regulatory and compliance requirements relevant to device risk management activities, ensuring adherence to industry standards. Lead risk ... Job DescriptionThe Senior Scientist, Device Risk Management Lead , is a crucial...analyses and Failure Modes and Effects Analysis (FMEA), implementing risk control measures, and performing overall device… more
- Insmed Incorporated (NJ)
- …We are seeking an experienced leader to oversee cybersecurity operations, enterprise risk management, and Computer Systems Validation (CSV) program. This role will ... manage cross-functional teams and ensure compliance with regulatory requirements while maintaining operational excellence. The Executive Director, Cybersecurity & … more
- Merck & Co. (Durham, NC)
- … Control Management, Quality Management Systems (QMS), Quality Metrics, Quality Risk Assessment, Quality Risk Management, Regulatory Compliance Consulting ... Job DescriptionThe Quality Associate Director/GMP Lead Site Auditor will have leadership responsibility for the site internal audit program, encompassing the full… more
- Merck & Co. (Rahway, NJ)
- … regulatory , quality, company, and customer requirements.-This position will lead cross-functional development teams within and external to Device Development & ... and development; manufacturing process development, qualification, and validation; and design control and risk management techniques to positively support and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …protocols and reportsServe as reviewer/author of a variety CMC sections or regulatory submissions, risk assessments, validation impact assessments, global change ... the treatment of multiple myeloma.Legend Biotech is seeking Validation Lifecycle & Technical Lead as part of the Global MSAT team based in Remotely. Role… more
- Usaa (San Antonio, TX)
- …product volume, quality, and business value delivery. Accountable for overall team regulatory , risk , and internal control compliance. Ensures industry ... understanding and translating needs into requirements. Expert knowledge of relevant regulatory compliance, industry regulations, risk management practices, and … more
- Merck & Co. (North Wales, PA)
- …clinical trial processes as well as quality management systems and quality control tools.Expert knowledge of GCP/ICH and worldwide Regulatory Health Authority ... and Acquisitions (M&A), Operations Support, Pharmaceutical Management, Quality Management, Regulatory Inspections, Regulatory Submissions, Risk Assessments,… more
- Merck & Co. (Rahway, NJ)
- …with regulatory , company, and customer requirements. - Principal Responsibilities Lead /Support continuous improvement initiatives for design control and ... responsible for leading and supporting continuous improvement initiatives related to design control and risk management processes for combination products. This… more
- Merck & Co. (Durham, NC)
- …documents to support regulatory filings including technical reports and risk assessmentsAuthor or approve Change Control documentation for complex process, ... Process Optimization, Process Technologies, Procurement, Professional Integrity, Project Management, Risk Control Assessment, Root Cause Analysis (RCA),… more
- JABIL CIRCUIT, INC (Hunt Valley, MD)
- …and Client to ensure validation strategies support product lifecycle and regulatory submissions. Manage risk -based validation approaches and implement continuous ... Job Summary: The Director of Validation will lead all validation activities across pharmaceutical and medical device manufacturing operations with a strong focus on… more
- ValSource, Inc. (Rahway, NJ)
- …regulatory requirements. ResponsibilitiesOn-Site Project Management: Interface with clients, lead teams of validation professionals, and provide subject matter ... currently looking to identify experienced and technically skilled leaders with Project Lead and Project Management experience to support a variety of exciting… more
- Cipla (Central Islip, NY)
- …favorable contracts, identifying cost-saving opportunities, and maintaining compliance with regulatory and company policies. Success in this position requires deep ... performance in alignment with Global procurement and with company objectives. Lead efforts to identify opportunities for cost savings, process improvements, and… more
- Merck & Co. (Rahway, NJ)
- …and execution, along with leadership skills to shape the technical capabilities lead a global, cross-modality technical team.The Associate Director will lead ... and 3rd party logistics sites, supply chain and technology teams, and regulatory and project leaders. The successful candidate will demonstrate ownership and make… more
- Cipla (Fall River, MA)
- … regulatory requirements. Ensure that the company remains compliant with all regulatory requirements (eg, FDA, ICH, EMA). Support risk assessments and help ... Fulfil the requirement of regulatory submission while closely working with regulatory teams. Prepare and review risk assessment (FMECA) for various facility,… more
- Repligen (Waltham, MA)
- …ensure "controls by design."Maintain ITGC narratives, process flows, and risk / control matrices.Identify and drive process improvements, automation opportunities, ... ITGC and SOX processes.Utilize data analytics to enhance testing quality, reduce risk , and improve audit coverage.Stay current on regulatory requirements (SOX,… more
- Cipla (Fall River, MA)
- …and regulatory auditors. Performs weekly quality reviews of Master Control database by assuring new documents have been entered using appropriate protocols. ... validation of equipment and products in compliance with site SOPs and regulatory guidance. Provides data to support management evaluation of performance trends. Owns… more
- Merck & Co. (Rahway, NJ)
- …of DCT deliverables including - robust processes & analytics, an integrated control strategy, successful tech transfer packages, filing and approval, and a robust ... risks across all factors that may impact technical, operational & regulatory success or timelines. -Analyzes and develops innovative solutions to unforeseen… more
- Cipla (Fall River, MA)
- …and regulatory auditors. Performs weekly quality reviews of Master Control database by assuring new documents have been entered using appropriate protocols. ... of API equipment and products in compliance with site SOPs and regulatory guidance. Autonomously leads and manages projects to implement continuous improvement… more
- Merck & Co. (North Wales, PA)
- …data assets while ensuring compliance with applicable US privacy and regulatory requirements. Position Responsibilities Treat data as a strategic asset to ... gaps versus the ideal state, prioritizing gaps and building execution plans. Lead acquisition of new external assets, formation of partnerships to co-create… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Manufacturing Science and Technology team reporting to the Manufacturing Execution Systems Lead and will be responsible for providing project management support to ... The major responsibilities will include but are not limited to: Lead project core teams to ensure on time project...for MES and/or digital projects and ensures that quality, risk , cost, time are managed within the overall approved… more
