23 risk manager jobs found in Waltham

Repligen Overview Make a global impact-join Repligen. We're united by a mission to inspire advances in bioprocessing as a preferred partner in the production of biologic drugs that improve human health worldwide. No matter your role or background, at Repligen, you will play a key part in shaping some of the most innovative and life-changing therapies in the world. We foster a culture of purpose, collaboration, and shared success-where every voice matters and every contribution drives progress. Join us! The Senior Accounts Receivable Manager is a key member of the Controllership organization, responsible for leading the company's domestic accounts receivable operations including billing, collections, and credit management to ensure timely and accurate cash collection. This role oversees the AR team and drives process standardization and operational improvements across the global order-to-cash cycle. The Senior AR Manager owns the company's customer credit policy, monitors...

Alkermes, Inc. As a Project Manager, you will support Alkermes in advancing a comprehensive AI strategy through our INDIGO program, an enterprise-wide initiative to expand the impact of machine learning and AI capabilities across our business. Your role will involve leading cross-functional projects supporting the R&D AI workstream within INDIGO and partnering closely with the INDIGO Program Manager to further establish the team's agile transformation. By aligning outcomes and processes with strategic goals and ensuring that projects are delivered on time and in budget, you will be pivotal in contributing to best practices, shaping INDIGO operations, and ensuring successful outcomes on Alkermes' investments in ML and AI technologies and products. Competitive candidates must demonstrate strengths in collaboration, organization, problem solving, facilitation, communication, and thrive in a fast paced environment. They bring deep experience in agile project management,...

Alkermes, Inc. Position Summary As Director, AI Strategy for the INDIGO AI Innovation Lab, you will serve as the enterprise thought partner and catalyst for responsible, highvalue AI adoption across functional areas such as Commercial, R&D, and Operations. You will cocreate businessled AI roadmaps, size value opportunities, establish and run enterprise AI governance processes, and lead broad enablement processes so colleagues can confidently and safely use internal and external AI tools. You will collaborate closely with functional AI topic leads and the INDIGO program manager, while building an AI strategy team as the function matures. This role operates at the Director level and requires a blend of strategic acumen, governance expertise, AI knowledge, and strong communication that translates AI potential into measurable business impact. This role will work a weekly hybrid schedule in our Waltham office. Responsibilities Essential Areas of Responsibility AI...

Alkermes, Inc. The Sr. Manager position within Clinical Supply Chain leads end-to-end supply chain management on multiple clinical programs as part of a growing, dynamic Pharmaceutical Development organization. They work closely as the key point of contact with Clinical Operations, Regulatory Affairs, Quality, Internal & External Manufacturing, and other Clinical Supply Chain personnel leading supply activities for complex programs that may require multinational interactions. In addition, they coordinate and lead supply activities with both internal and external partners. The successful candidate will thrive in a highly collaborative team environment to ensure the successful development of new drugs. Responsibilities Prepare, update and monitor program budgets and ensure financial Key Performance Indicators (KPIs) and relevant cost saving targets Proactively lead clinical program supply strategy ensuring trial design, enrollment timeline, manufacturing availability and...

Alkermes, Inc. Alkermes is seeking an experienced Program Manager to support our ALKS 2680 program which is currently in Phase 2 development and preparing for Phase 3 and registration. ALKS 2680 is a novel, investigational, oral, selective orexin 2 receptor (OX2R) agonist in development as a once-daily treatment for narcolepsy and idiopathic hypersomnia. This person will work closely with members across our organization including areas such as research, pre-clinical, clinical, pharmaceutical development, regulatory affairs, medical affairs, commercial, operations, policy and government affairs, patient engagement and corporate communications, as well as the senior management team to orchestrate development and execution of our fully-integrated program strategic and operational plans to support key corporate goals including the development and ultimate approval of ALKS 2680 as well as identify and execute a comprehensive lifecycle management program. This is a hybrid on-site...

CSL CSL is transforming its R&D organization to accelerate innovation and create greater impact for patients. With a streamlined, project-led structure and a focus on collaboration, we're building a future-ready team that excels in dynamic biotech ecosystems. Joining CSL now means being part of an agile team committed to developing therapies that make a meaningful difference worldwide. Could you be our next Senior Manager US Advertising and Promotion Lead? The job is in our King of Prussia, PA, Waltham MA, Zurich Switzerland or Maidenhead UK office. This is a hybrid position and is onsite three days a week. You will report to the Head, Global Advertising & Promotional Position Purpose Provide an overview of the responsibilities of the position by summarizing the most important aspects and duties. Ensure compliance with HA drug promotion and promotional labeling regulations for assigned licensed products. Review, approve, or reject promotional...

Alkermes, Inc. This position is an integral part of the CQA team and provides oversight for and participates in, auditing services in support of Alkermes Clinical Programs by conducting clinical site, vendor qualification, internal systems and document audits to ensure compliance with cGCPs. The CQA Manager supports the department initiatives by leading CQA projects and assists with management of department resources. This position must be able to quickly identify critical and high risk business and compliance issues and report immediately to CQA management and assist/lead investigations and/or corrections of such issues. Travel requirement of 40% - 60% Responsibilities This position will : Schedule, personally conduct and/or supervise Good Clinical Practice (GCP) audit services by an external vendor/consultant and/or internal resources (auditors) which will support Clinical Development activities including but not limited to: Audits of clinical vendors, clinical sites...

Wabtec Company Description Evident's Inspection Technologies division is now a part of Wabtec Corporation. Read more. Job Description The incumbent will design mechanical systems as part of the development of new products related to the test and measurement market in an agile R&D setting. The incumbent will supervise and approve the work of designers under their supervision where applicable and ensure an exemplary level of quality in the concepts developed. The incumbent will work in collaboration with multidisciplinary teams in a state-of-the-art development environment.   Specific Responsibilities General Product Development: Contribute to the analysis, understanding and documentation of product requirements and functionalities in collaboration with the  project lead and other disciplines; Develop and propose mechanical concepts as part of product development; Develop the mechanical performance requirements of the parts and assembly (norms and standards,...

Alkermes, Inc. The Senior PV Scientist serves as a critical medical analytic and coordinating role in partnership with the Safety MD/Medical Monitor for assigned marketed and/or investigational product(s). The Senior PV Scientist is expected to be equally effective in working collaboratively or independently. She/he must demonstrate effective leadership skills with cross functional partners to ensure that signaling, safety data analyses/authorship for ad hoc queries and aggregate reports are of high quality and are completed and submitted according to required timelines. For investigational products, this role may also participate in protocol design, safety CRF development, safety monitoring plan, support of DSMB activities, coding review as well as SAE reconciliation activities. The Senior PV Scientist also plays a key role in ensuring that the above activities remain compliant with evolving regulations, that respective SOPs and work instructions regarding signaling, ad hoc and...

National Grid Find your superpower with the Graduate Development Program National Grid's Graduate Development Program (GDP) is a year-long development program for recent college graduates who aspire to take on future leadership roles in a dynamic, ever-changing industry. Graduates will shape the future of National Grid. Bringing fresh thinking, new perspectives, and exploring with energy, we'll give you real responsibility and an opportunity to move with purpose from day one - putting the power to supercharge your career in your hands. Graduates start their careers at National Grid with an in-depth 3-week in-person Orientation which gives you exposure to all parts of the company, allows you to network with your Graduate cohort, GDP alumni, and senior leaders, and provides you with the opportunity to travel throughout our service territory in the northeast US. Following Orientation, you'll begin working in full-time position outlined below and take part in ongoing...

Alkermes, Inc. We are seeking an individual who is talented, motivated, and passionate about science to join our Regulatory Strategy team. As a Director of Regulatory Affairs, the successful candidate will play an important role in guiding new products into the clinic and setting the stage for registration. The individual in this role will serve as a Regulatory Lead for pipeline drug development programs and marketed products, and will be responsible for developing, implementing, and driving global Regulatory strategies. The ideal candidate will have a strong scientific background, broad experience developing drugs, and the ability to leverage that experience to impact program teams beyond regulatory strategy. This role reports to the Executive Director, Regulatory Strategy. Responsibilities Serve as Regulatory Lead, representing the Global Regulatory Team on cross-functional development teams Develop and implement global regulatory strategies for pipeline drug...

Alkermes, Inc. The Senior Director, Emerging Technology and Engineering is a critical leadership role responsible for defining the company's technology future across Enterprise Architecture, Data, Advanced Analytics, and core Engineering practices. This role manages an integrated function to ensure our IT roadmap, digital strategy, core technologies, and AI/Analytics capabilities are designed to drive competitive advantage, accelerate business insights, enhance decision-making, and are implemented with high-quality engineering standards. The Senior Director will serve as a primary interface for the Emerging Technology and Engineering Team within the Global IT organization while championing the adoption and maturity of advanced data and analytical capabilities across the enterprise. This role will work a hybrid weekly office schedule in our Waltham location. Responsibilities Strategic Leadership Build and mature IT capabilities to support current and emerging...

Alkermes, Inc. The Executive Director, IT R&D will oversee an IT organization that drives the standard and compliant delivery of IT R&D support and services. Key objectives for this role will be to establish technology delivery standards for the R&D function based on business need. The role will be responsible to plan, direct, and manage the IT solutions for Clinical, Drug Safety, Regulatory, Medical Affairs and the Research and Development areas within Alkermes and provide leadership and knowledge empowerment for team members and mature the IT R&D services within the company. This role will be a key member of the IT Senior Leadership Team and will be the primary liaison between various internal and external IT organizations and the previously mentioned Alkermes functional areas. This position will report to the Chief Information Officer (CIO). This role will work a weekly hybrid office schedule in our Waltham location. Responsibilities Job...

Alkermes, Inc. The Executive Director, Enterprise Data Management is responsible for leading and expanding enterprise data management capabilities that support all functions-with an initial focus on R&D and Commercial. This role will drive the continued development and execution of the company's enterprise data strategy, strengthen data governance, oversee data acquisition and master data management (MDM), scale data operations, and accelerate the delivery of data solutions that meet key business needs and support AI / analytics / reporting solutions. This role will lead several teams of data professionals, including an existing Commercial Data Management team, a new R&D Data Management team, and a new Enterprise Data Governance specialist. Depending on start date, this position will lead the hiring of new positions for R&D Data Management and Enterprise Data Governance. This role will work a weekly hybrid schedule in our Waltham office. This role will report to...

Revvity Revvity is embarking on a multi-year digital transformation journey to modernize our technology platforms and simplify our business processes. We are seeking an experienced Program Director to help govern and execute multiple digital initiatives. This is a high visibility, high impact program and one of key pillars of Revvity's Transformation journey. The Program Director will play a critical role in advancing the digital initiatives, with accountability for helping manage the Digital Roadmap, budgets, schedule, risk and progress. You will help plan and govern multiple workstreams across various functions, by understanding requirements, complex interdependencies, working closely with business partners and system integrators. You will work with cross-functional teams, aligning digital transformation objectives with business stakeholder needs. Therole will report into Head of Digital Transformation and will be based out of Waltham, MA. *Option for Hybrid work...

Alkermes, Inc. Associate Director, External Operations API API process expert responsible as the technical lead representative supporting API manufacturing at Contract Manufacturing Organizations' (CMO's) and subsequent processing of API's in Drug Product (DP) processes across OSD and injectables. Required to support new product introductions, technology transfers, continually monitor and improve API operations conducted at CMO's on behalf of Alkermes. Responsibilities General Review and maintain Alkermes practices & systems in managing contract manufacturers to ensure compliance with cGMP, and other regulatory requirements - ensuring that appropriate policies, rules, regulations and agreements are followed. Understanding of chemical processes from both scientific and engineering perspective demonstrating expertise in how API processes are developed and controlled to maximize yield and minimize impurities. Perform trending on CMO API processes and identify...

Alkermes, Inc. An intermediate level technician position primarily responsible for general maintenance and preventive maintenance activities of our Oral Solid Dose clinical manufacturing equipment. The role will operate under limited direct supervision and charged with keeping the equipment within operational specifications and safe. Essential duties include the corrective and preventive maintenance of the OSD equipment. The role will assist with troubleshooting, Identification, and implementation of process/equipment improvements (utilizing Change Control systems) to reduce waste and increase process reliability. Assure the resolution of deviations, corrective actions, action items from Change Control systems, and any audit non-compliance items. Perform process and equipment evaluation to identify risks and weaknesses in new and current processes. Responsibilities Perform PM's Follow Written Preventative Maintenance Procedures Accurately complete maintenance...

Alkermes, Inc. The primary responsibilities of an Associate Director in the Nonclinical Safety Evaluation (NSE) organization are to (1) design and implement nonclinical safety assessment strategies to support the nomination and development of Alkermes' diverse small molecule drug candidates and (2) communicate strategies and findings internally and to regulatory authorities globally. The Associate Director is the single point of accountability within NSE for all strategic, scientific, study-related, and regulatory aspects of the programs he/she manages. The Associate Director in NSE has a broad understanding of toxicology and regulatory requirements to progress candidates through clinical development and is recognized by internal peers for his/her scientific contributions and deliverables (within discipline) to Discovery and Development programs. The individual has specific expertise in one or more areas relevant to nonclinical safety evaluation, shows competency in all aspects,...

Alkermes, Inc. The Sr. Medical Director/Medical Director, Global Safety Officer (GSO) will work closely with the DSPV leadership team and will provide strategic safety oversight, for the assigned investigational and/or marketed products, for the Alkermes Neuroscience portfolio. Reporting to the Head of DSPV, the GSO will serve in a visible role in providing safety advisement in several company-wide forums and initiatives. Demonstrated prior career success as a product safety physician, having led clinical and post-marketing programs as the Safety lead, working in close partnership with the cross-functional teams. This individual will be responsible for collaborating and working effectively with key stakeholders and keeping the DSPV leadership informed of evolving safety issues and strategies. Key success factors also include building high trust, accountability and demonstrating a sense of urgency in leading critical projects, showing the capability to work either independently...

Alkermes, Inc. We are seeking a highly motivated, experienced hands-on Associate Director of Information Security (Cloud and Emerging Technology) to take a leadership role in shaping and executing the organizations security strategy in advanced technologies. Reporting to the Director of Information Security, this position will oversee a small team of security professionals and act as a trusted advisor across IT, and business units. This role will be responsible for developing, implementing, and enforcing security frameworks and guardrails for cloud environments (primarily AWS), AI/ML platforms, Large Language Models (LLMs), and DevSecOps practices. In this role, the Associate Director will lead efforts to secure cloud and emerging technologies, ensuring compliance with regulatory requirements and alignment with organizational risk appetite. Responsibilities Essential Duties and Responsibilities Lead, mentor, and manage a small team of security professionals, fostering...