- Merck & Co. (Rahway, NJ)
- …conducting system hazard analyses and Failure Modes and Effects Analysis (FMEA), implementing risk control measures, and performing overall device risk ... internal and external sites ensuring proper translation and implementation of risk control measures.Analyze information from post-market surveillance, clinical… more
- Merck & Co. (Rahway, NJ)
- …external suppliers.Understand and apply regulatory / compliance requirements relative to design controls and risk management activities. Lead the preparation ... and customer requirements.- -Principal ResponsibilitiesLead/contribute to device development, design controls for the assigned projects. Lead the implementation… more
- Repligen (Waltham, MA)
- …an effective internal control framework that spans all global operations. Lead the SOX compliance program, including risk assessments, documentation, testing, ... the SOX program. Shape and execute compliance strategy across a global company Lead SOX risk assessments, audits, and remediation efforts Partner with senior… more
- Merck & Co. (Rahway, NJ)
- …for how automation interacts with ITSM, detection engines, identity systems, and risk scoring frameworks.Serve as lead integrator between the Automation & ... Job DescriptionWe are seeking a solution-oriented Platform Engineering Lead to drive automation and orchestration across the cybersecurity technology stack. This is… more
- Merck & Co. (Durham, NC)
- …controls . Approve cleaning validation documentation as needed. May act as a Quality Risk Assessment Lead . - - Education Minimum Requirement: - High School ... including biotech culture growth, harvest, lyophilization, product inspection, and quality control laboratories. - The Quality Assurance Specialist will support this… more
- Novo Nordisk Inc. (Durham, NC)
- … and SME to operate within compliance with a quality mindset that focuses on risk management & mitigation Lead the training & implementation of effective change ... Team Novo Nordisk and help us make what matters. The Position Serve as a Lead & Subject Matter Expert (SME) to provide technical expertise supporting site data and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and responsible for presenting the strategy in health authority inspections.Assess change controls , risk assessment, trend reports and SOPs/Work Instructions for ... Legend Biotech is seeking a Contamination Program Lead as part of the Technical Operations team...will be responsible for creating and maintaining the contamination control strategy program for the Cell Therapy facility following… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- Aseptic Manufacturing LeadPosition Summary:The Aseptic Manufacturing Lead plays a critical role in overseeing aseptic manufacturing activities. A strong background ... microbiology and experience in aseptic manufacturing are required. The Aseptic Manufacturing Lead will actively participate on the production floor by leading a team… more
- Raytheon (Tewksbury, MA)
- …tough, meaningful problems that create a safer, more secure world.The Sensor Controls & Electronics Department within Raytheon is hiring an Electrical Engineering ... Project Lead with strong technical leadership ability. The project ...internal and external design reviews, team coordination, issue resolution, risk and opportunity management.What You Will DoCandidate will work… more
- Novo Nordisk Inc. (Durham, NC)
- …include review of batch reports & release of incoming materials, deviations, change controls , review & approval of SOPs, QA presence & process confirmation on shop ... shop floor Ability to support all processes & functions in Department Quality Risk Management Make decisions on quality & compliance issues with little guidance… more
- Novo Nordisk Inc. (Boulder, CO)
- … control strategies. Review and approve change controls , in-process control sampling plans, and CAPA's Perform risk evaluations of manufacturing processes ... oligonucleotides. Ensure process strategies developed at laboratory scale can achieve control limits and specifications intended for large scale manufacturing Serve… more
- Merck & Co. (Rahway, NJ)
- …responsibilities include but are not limited to: Ensures compliance (Quality Risk management, Deviation Management, Product Release, Change Control ); Meeting ... between our Manufacturing Division and the contract manufacturer leveraging the " Control Tower" and establishes boundaries and ground rules of engagement.-He or… more
- Merck & Co. (Rahway, NJ)
- …The position also involves strategic collaboration with Chemistry, Manufacturing, and Controls (CMC) and Regulatory teams regarding control strategies and ... development.In this role, the SMAR&D Director will provide guidance, lead initiatives, and build teams responsible for developing characterization methods… more
- Tris Pharma (Monmouth Junction, NJ)
- …Investigations and Product Quality Complaints Team to ensure manufacturing quality controls and procedures are followed in accordance with Standard Operating ... and cross functionally throughout company (ie, QA Operations, Quality Control (QC), Manufacturing, Operations, Technical Services, Senior Leadership, etc.) on… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- Position Summary:Oversee and lead the validation program for production equipment and processes used to support manufacturing of aseptic and terminally sterilized ... products. Lead the validation team in the establishment and maintenance...validation, computer system validation and calibrationPerform functional and process risk assessments in conjunction with Quality and Manufacturing subject… more
- Merck & Co. (Austin, TX)
- …enabling automation pipelines that support AI-driven defense and enterprise-scale risk reduction.Job Description:You'll be working in a forward-leaning engineering ... will be foundational to how we scale AI, automate risk response, and reduce manual toil across the enterprise.As...automation workflows under the direction of the Platform Engineering Lead . You will be expected to go beyond implementation-to… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and will work to establish, oversee and maintain processes, procedures and controls associated with Adverse Event (AE) and Technical Complaint (TC) reporting from ... with relevant teams to streamline case management processes and enhance efficiency. Lead Case Management and Medical Review Direct the management of safety cases,… more
- Merck & Co. (Durham, NC)
- …and customer service-oriented leader to support the VMF IPT. Will lead the tactical and strategic equipment reliability improvements, human resources activities ... -Responsible for major equipment related projects, including funding, change control and equipment qualification within their areaResponsible for obtaining bids,… more
- Merck & Co. (Rahway, NJ)
- …to evaluate process health and effectiveness and provides ongoing service control and sustainability.Aligns with GBS, Finance, Procurement Category, SDPM and other ... compliance and execution.Responsible for to complete internal and external 3rd party risk assessments, prior to contracting and to maintain accurate records of … more
- Merck & Co. (Austin, TX)
- …Engineer to join the Cybersecurity Automation & AI team. This role will lead the design and delivery of scalable automation solutions across enterprise platforms ... platforms.Engineer workflows that eliminate redundant tickets, reduce toil, and surface risk insights in real time.Collaborate with domain teams (IAM, Endpoint,… more
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