190 operations jobs found

CSL The Global Regulatory Affairs CMC - Decision Support Lead is responsible for: Providing comprehensive administrative support to the Head of Global Regulatory Affairs CMC to enable the Head of Global Regulatory Affairs CMC to focus on strategic priorities and organizational leadership. This role requires exceptional attention to detail, strong communication skills, maintaining the highest level of confidentiality, and the ability to manage multiple priorities simultaneously. Providing targeted administrative support to the Global Regulatory Affairs CMC leadership team, ensuring the efficient operation of departmental activities. Tracks departmental business actions, goals, objectives, KPIs, and commitments to internal stakeholders. Supports the Head of Global Regulatory Affairs CMC in department-wide resource planning and forecasting through data-driven resource analysis. Partners with finance, HR, and project managers to support workforce planning, hiring...

Land O'Lakes Night Shift Operations Specialist The Operations Specialist is an integral part of the Technical Services Department, serving as an on-the-shop-floor leader during the night shift. This role is primarily focused on supporting manufacturing operations and ensuring smooth facility performance. The Operations Specialist provides backup supervision, prepares the floor for corporate R&D research projects, and actively participates in the execution of ongoing capital improvements. The majority of work hours will be spent directly on the manufacturing floor, supporting production teams and operational excellence. Schedule: Nightshift is 6PM-6AM; 2-2-3 Rotating-Shift Schedule Salary Range: $79,000-$100,000 Annual Key Responsibilities Lead shop floor teams to improve plant performance and efficiency, fostering informed decision-making and enhancing employee satisfaction and relations. Serve as a backup production supervisor for all shifts, providing...

CSL Reports to: Associate Director, Clinical Trial Business Operations Position Summary The Senior Manager, Clinical Trial Business Operations (CTBO) oversees CRO execution of investigator site budgets, contracts, site payments, and ICF deliverables. This role is also responsible for coordinating clinical trial insurance needs and supporting Sunshine Act/transparency reporting requirements. The Senior Manager ensures operational consistency, manages escalations, and contributes to compliance, quality, and governance activities. Key Responsibilities CRO Oversight Review and oversee CRO work related to budgets, contracts, payments, and ICFs. Ensure accuracy, quality, and alignment with internal templates, processes, and parameters. Provide operational guidance to CRO teams to ensure consistency across regions and studies. Escalation & Issue Management Manage escalations exceeding CRO negotiation authority. Partner with Clinical Operations,...

Wabtec Job Description How will you make a difference? The purpose of the Business Operations Leader role in LADM is to drive operational excellence in the overall business performance to help deliver high value-add solutions to our customers with appropriate business profitability, cost efficiency, and quality through the use of consistent metrics, tools, and processes, and sharing of best practices across the LADM portfolio, in alignment with the rest of the Digital Intelligence business. You will collaborate with business leaders and cross functional peers to build and communicate operational metrics and processes, organizational strategies, resource planning strategies, integration & synergy plans, and research & development (R&D) investment plans to drive profitable growth and organizational harmonization in alignment with the strategic priorities of the Digital Intelligence business. This role will report to the Group Vice President. What will your...

CSL The Role: Reporting to the Sr. Manager Finance Supply Chain & Procurement, as the Sr. Financial Analyst, Global Operations , you will play a key role on the CSL Behring Global Operations team by supporting financial analysis and decision-making by providing detailed financial modeling, data analytics, and strategic business collaboration. You will focus on delivering insights to optimize financial performance, ensure accountability for results, and drive continuous improvement across the business. This is a hybrid role, which offers a combination of an onsite and remote work schedule. #LI-hybrid The Opportunity: Conduct financial analyses to support business initiatives, including evaluating various scenarios, cost optimization, and performance improvement efforts. Develop and maintain financial models to assess the impact of key business decisions on overall financial performance. Collaborate with cross-functional teams, including Finance, Operations, and...

AIT - Arctic Information Technology, Inc Overview: This summer internship is for Doyon Shareholders. JOB SUMMARY: This internship is designed for a student with little or no prior experience who is eager to learnbusinessoperations. The intern will receive training and support whileassisting the Director of Federal Growthand their teamwith administrativetasks,including document organization,record keeping,and trackingupdates across the growth proposal contract workflow. Responsibilities: EXPERIENCES TO EXPECT: Drafting clear internal emails, meeting notes, and action-item recaps using provided templates Managingassignedtasksanddeadlines for proposals, contracting, and sales support activities Using Microsoft 365 tools (Outlook, Teams, Word, Excel, PowerPoint, OneDrive/SharePoint) to support coordination and document work Learning internal systems and processes (CRM, contract repository, Teams/SharePoint) and completing basic updates and file organization...

CSL CSL's R&D organization is accelerating innovation to deliver greater impact for patients. With a project-led structure and a focus on collaboration, we're building a future-ready team that thrives in dynamic biotech ecosystems. Joining CSL now means being part of an agile team committed to developing therapies that make a meaningful difference worldwide. The Director Clinical Operations Lead is accountable for the development of the operational strategy for a clinical study(ies) and/or a clinical program (s) as well as the end-to-end study management and delivery of all operational activities and budget management relating to assigned clinical study (ies)/program(s). Responsibilities encompass support to the development of the operational strategy for our most complex studies and ensuring achievement of all program goals within established timelines, budget, and quality standards, and according to the TA strategies. This role must be experienced in working in a matrix...

CSL This position will lead the transformation of project leadership capabilities across the R&D enterprise. On a systemic level, this role will prepare critical GPL roles (Exec Directors) to be CEO of the project via a bespoke leadership/drug development/executive training and coaching program which will equip these leaders and associated project teams to navigate ambiguity, prioritize effectively, and make high-impact R&D investment decisions that accelerate innovation and deliver value to patients. This position will work with the CEO/GLG, RDLT and all levels to ensure the Project Operating Model is continuously improved for simple, rapid, empowered, project-centric decision making at the right level. This role will also lead the leadership development of Project Managers (PMs) and Research Project Leads (RPLs) in R&D and strengthen the GPL/GPM partnership. Main Responsibilities & Accountabilities *Develop and run an executive...

Doyon Management Services Overview: Superintendent / QCM / SSHO - USACE & NAVFAC Federal Projects Estimated salary range: $100,000 to $155,000 per year. Actual compensation may vary depending on experience, certifications, project requirements, location, and internal alignment/level. Enjoy profit sharing and excellent health benefits through the Federal Employee Health Benefits (FEHB) program Doyon Management Services (DMS) provides design-build and general construction services nationwide for government and military facilities. DGG is seeking experienced construction professionals to serve in a combined role of Superintendent, QCM, and SSHO on U.S. Army Corps of Engineers (USACE) or Naval Facilities Engineering Command (NAVFAC) federal projects. Key Responsibilities Manage daily field operations and supervise construction crews and subcontractors Develop, implement, and manage project Quality Control (QC) Plans Conduct site safety...

FreedomPay The FreedomPay Commerce Platform is the technology of choice for many of the largest companies across the globe in retail, hospitality, lodging, gaming, sports and entertainment, foodservice, education, healthcare and financial services. FreedomPay’s technology has been purposely built to deliver rock solid performance in the highly complex environment of global commerce. The company maintains a world-class security environment and was first to earn the coveted validation by the PCI Security Standards Council against Point-to-Point Encryption with EMV standard in North America. FreedomPay’s robust solutions across payments, security, identity and data analytics are available in-store, online and on-mobile and are supported by rapid API adoption. The award winning FreedomPay Commerce Platform operates on a single, unified technology stack across multiple continents allowing enterprises to deliver a consistent, repeatable experience on a global scale. FreedomPay is a fast...

CSL The Lead, Global Regulatory Affairs Device is responsible for: Developing, coordinating and implementing global Software as a Medical Device regulatory strategies for new combination and standalone medical devices. Ensure worldwide regulatory device compliance and successful market access across all regions. Closely collaborate with internal stakeholders on regulatory strategy issues, develop approaches to address regulatory and compliance matters, serve as primary liaison to the US FDA for device matters, and closely work regional regulatory staff to engage with international health authorities. Represening CSL in official device regulatory capacities and acting as an authorized official or responsible person in interactions with regulatory agencies. This role promotes strong cross-functional collaboration and effective communication across Global Operations, Plasma Operations, R&D, Global Regulatory Affairs, and other relevant CSL business functions to...

CSL The Lead, Global Regulatory Affairs Device is responsible for: Partnering closely with R&D, Manufacturing, Operations, Quality, and Regulatory Affairs stakeholders to address regulatory strategy challenges and deliver innovative, timely regulatory solutions that meet evolving device regulatory and compliance requirements for plasmapheresis devices, drug device combination products, standalone drug delivery devices, and ancillary devices. Ensure worldwide regulatory device compliance and successful market access across all regions. Closely collaborate with internal stakeholders on regulatory strategy issues, develop approaches to address regulatory and compliance matters, serve as primary liaison to the US FDA for device matters, and closely work regional regulatory staff to engage with international health authorities. Represening CSL in official device regulatory capacities and acting as an authorized official or responsible person in interactions with...

CSL The Senior Manager, R&D Outsourcing is responsible for managing the full contracting lifecycle for strategic outsourced R&D services and projects across assigned therapeutic and functional areas. This includes drafting, reviewing, and negotiating scopes of work, budgets, and contracts with external service providers to support CSL's global clinical and portfolio development needs. This individual contributor role partners closely with Business Strategy Leads, Project Owners, Legal, Finance, and Procurement to ensure timely contract execution, cost control, and compliance with CSL's policies and standards. Outsourcing Execution Manage vendor identification, RFI/RFP processes, proposal reviews, and budget and contract negotiations for strategic outsourced R&D services (e.g., MSAs, Work Orders, Change Orders, rate cards). Draft, review, and finalize contracts to ensure timely execution and compliance with CSL policies. Coordinate with project teams and...

CSL Position Purpose The Head of Global Regulatory Affairs Device is responsible for: Providing strategic leadership and operational oversight for the Global Regulatory Affairs Device function. Leading the global regulatory strategy and execution for CLS's medical device portfolio during development and post-approval lifecycle, including plasmapheresis devices, blood establishment computer software (BECS), drug device combination products, standalone drug delivery devices, ancillary devices, and software as/in a medical device (SaMD/SiMD). Ensure worldwide regulatory device compliance and successful market access across all regions. Closely collaborate with internal stakeholders on regulatory strategy issues, develop approaches to address regulatory and compliance matters, serve as primary liaison to the US FDA for device matters, and closely work regional regulatory staff to engage with international health authorities. Represening CSL in official...

Merck Job Description Position Overview The Senior Specialist, Data & Analytics plays a critical role in advancing data-driven decision-making across Animal Health Global Supply Chain Management (AH GSCM). This position sits at the intersection of analytics, digital supply chain systems, and operational execution-transforming complex, multi-system data into scalable insights that improve service, inventory performance, manufacturing reliability, and risk mitigation in a regulated manufacturing environment. In this role, you will move beyond reporting to architect analytical solutions that directly influence planning parameters, supply network decisions, performance management, and continuous improvement initiatives. You will work cross-functionally with Supply Chain, Manufacturing Operations, IT, Finance, and Quality stakeholders to translate business challenges into structured data models, automated dashboards and system-integrated analytical tools that drive...

Merck Job Description This position reports to the Associate Director, Global Clinical Supplies Quality, and is critical in maintaining the global clinical supply chain via disposition activities for clinical finished goods provided by our Company for worldwide clinical trials. Specifically, this includes batch documentation review ensuring our clinical supplies are in compliance with current Good Manufacturing Practices (cGMPs) regulations and relevant regulatory filing submissions. Areas of focus of this position revolve around the detailed workings of clinical packaging, labeling and distribution activities and associated regulatory submissions for Investigational New Drug Applications and Clinical Trial Applications in relation to complex/niche supply chains and supply types for clinical protocols as well as Managed Access Programs, Joint Ventures/Collaborations, Independent Investigator-Initiated Studies, etc. Primary duties may include but are not limited to the...

Merck Job Description Support the Lead Epi Scientists by providing overall operational support for study conduct. Responsible for the coordination and execution of observational or non-interventional research studies (including Post Authorization studies), in compliance with Good Pharmacoepidemiology Practice (GPP) and Standard Operating Procedures (SOPs). Manages several complex activities and study types. Our Clinical Research and Pharmacovigilance team push the boundaries of global healthcare through research and innovation. Through clinical trials and surveillance, we ensure the safety and efficacy of our existing and pipeline products to produce safe, effective, innovative medicine. Primary responsibilities include: Operational planning and project management of epidemiology research studies Execution, and close out of primary data collection, chart review, database, and molecular epidemiology studies in addition to other activities Manage vendors...

Merck Job Description The Executive Director, Customer Service Center Strategy & Ops Leader (ED, CSC) reports to the Associate Vice President of US Marketing Operations in Commercial Excellence & Innovation and leads the overall US Customer Service Center organization with accountability to direct the strategy and execution of engagements with Healthcare Professionals, Patients, Consumers, and Employees across five contact centers with primary focus in the US. This accountability extends to include operational performance, regulatorycompliant intake, and largescale service modernization. This role directs a complex, multilayered organization of approximately 80 Full Time Employees, including multi-level leaders, people managers, and frontline teams responsible for critical, highly regulated customer and patient interactions. The ED, CSC sets the vision, strategy, and governance for a critical service organization that supports Healthcare Professionals, consumers,...

Merck Job Description Support the Lead Epi Scientists by providing overall operational support for study conduct. Responsible for the coordination and execution of observational or non-interventional research studies (including Post Authorization studies), in compliance with Good Pharmacoepidemiology Practice (GPP) and Standard Operating Procedures (SOPs). Manages several complex activities and study types. Our Clinical Research and Pharmacovigilance team push the boundaries of global healthcare through research and innovation. Through clinical trials and surveillance, we ensure the safety and efficacy of our existing and pipeline products to produce safe, effective, innovative medicine. Primary responsibilities include: Operational planning and project management of epidemiology research studies Execution, and close out of primary data collection, chart review, database, and molecular epidemiology studies in addition to other activities Manage vendors...

Merck Job Description The Executive Director, Customer Service Center Strategy & Ops Leader (ED, CSC) reports to the Associate Vice President of US Marketing Operations in Commercial Excellence & Innovation and leads the overall US Customer Service Center organization with accountability to direct the strategy and execution of engagements with Healthcare Professionals, Patients, Consumers, and Employees across five contact centers with primary focus in the US. This accountability extends to include operational performance, regulatorycompliant intake, and largescale service modernization. This role directs a complex, multilayered organization of approximately 80 Full Time Employees, including multi-level leaders, people managers, and frontline teams responsible for critical, highly regulated customer and patient interactions. The ED, CSC sets the vision, strategy, and governance for a critical service organization that supports Healthcare Professionals, consumers,...