- 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, ... Shape and execute compliance strategy across a global company Lead SOX risk assessments, audits, and remediation...remediation efforts Partner with senior leaders to embed strong controls into business processes Mentor and develop… more
- 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)
- …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. (Rahway, NJ)
- …responsibilities include but are not limited to: Ensures compliance (Quality Risk management, Deviation Management, Product Release, Change Control ); Meeting ... dealings between our Manufacturing Division and the CMO and establishes a strong business partnership as well as boundaries and ground rules of engagement. External… 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 ... us make what matters. The Position Serve as a Lead & Subject Matter Expert (SME) to provide technical...from the manager. Responsible for providing data-based insights as business and manufacturing intelligence to an end-consumer business… 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 ... role is responsible for the oversight of employees/activities performed at Global Business Support (GBS) hubs located in Mexico City, Mexico and Bangalore, India.… more
- Merck & Co. (Rahway, NJ)
- …findings and risk mitigation strategies proposed.Communicating the outcomes of risk assessments and informing business stakeholders about proposed mitigation ... of a comprehensive end-to-end sourcing process. This encompasses collaborating with key business stakeholders to gain a thorough understanding of goods or services… 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)
- …and innovation. Tris colleagues understand the criticality of operating a successful business and take pride in the company's success. But of equal importance ... Investigations and Product Quality Complaints Team to ensure manufacturing quality controls and procedures are followed in accordance with Standard Operating… 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 ... PROFILE Provides leadership and direction through individual contributorsExecutes functional business plans and contributes to the development of group… 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
- 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 ... reduce ticket volume, eliminate manual handoffs, and improve response time across critical business processes. This role is ideal for a hands-on systems engineer who… more
- Aequor (Thousand Oaks, CA)
- …desirable. Proven communication and facilitation skills. Demonstrated strong analytical skills, business acumen and risk management Training and/or demonstrated ... responsibility for more complex product planning and regional operations lead roles. Responsibilities Include: Demand Consolidation Review aggregate unit forecasts… more
- Merck & Co. (Rahway, NJ)
- …planning to enable facility startup. Upon start-up, the selected candidate will lead the daily mechanical activities and be responsible for the planning and ... work, elevated roof, and confined space entry.Lockout/Tagout and Energy Control Procedure implementation and developmentEmergency Repairs/TroubleshootingCalibration/Routine Preventative MaintenanceProcess Equipment… more
- Merck & Co. (Durham, NC)
- Job DescriptionThe Associate Director - Purification Technology Lead within the Vaccine Technical Operations organization will be responsible for tactical and ... technical/process issues, strategic projects, deviation management, change management, quality risk management, licensure and filing project management, and human… more
- Repligen (Waltham, MA)
- …Regulatory Affairs team will monitor external product compliance requirement and advise the business on any changes and actions to be taken. The Regulatory Affairs ... This senior leadership position will be required to participate in business reviews, external forums and support customer interactions, as necessary, including… more
- Formation Bio (New York, NY)
- …of quality, cost control , and on-time deliverables. Serve as the Operations Lead for clinical assets, programs, and studies. Step in as the Clinical Project ... ICH-GCP, FDA regulations, and other applicable regulatory standards. Champion proactive risk management by identifying and mitigating risks before they escalate.… 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 ... have strong understanding of product management systems and tools, strong business and financial skills, ability to manage multiple programs and create… more
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