19 continuous improvement manager jobs found in Waltham

Alkermes, Inc. Responsibilities Responsible for all quality systems in scope from the Global Process Function/Operational process standpoint. Report to the Director of Quality Systems and Compliance. Responsible for initial implementation and validation support, periodic review and operational support to maintain systems in a validated state. Facilitate development, maintenance, and reporting of Quality System metrics to senior leadership on a periodic basis. Facilitate development and implementation of Global SOPs/Standards/Guidelines with respect to Quality Systems Management in-line with Alkermes Quality philosophy, regulations, and industry best practices. Evaluate and lead initiatives on harmonization of Quality Systems management. Facilitate and lead continuous improvement of approach to quality systems and processes by identifying, proposing and implementing systemic changes. Coordinate with other impacted Quality groups and Site Process Owners to gather...

National Grid About us Superpowered. Meaningful work. Human impact. A story we're proud to tell. This is what matters to us at National Grid. In a world of complexity and unanswered questions, there is one thing we're certain about: the power of our people. National Grid is hiring a Lead Project Manager (Electricity), Capital Project Delivery for Massachusetts. This is a Onsite Role - Must live within a commutable distance to Waltham, MA. Job Purpose We are seeking a dedicated individual to oversee and execute the planning, delivery, management, and governance of our Electric Capital Projects. In this pivotal role, you will be responsible for ensuring that these projects are developed in a cost-effective and purposeful manner, while also improving long-term project robustness, requirements, costs, and timelines. Opportunities * Collaborate with a diverse and expanding team, sharing accountability for the timely delivery of capital infrastructure essential to...

National Grid About us Superpowered. Meaningful work. Human impact. A story we're proud to tell. This is what matters to us at National Grid. In a world of complexity and unanswered questions, there is one thing we're certain about: the power of our people. National Grid is hiring a Lead Project Manager, Capital Project Delivery for Massachusetts. This is a Onsite Role - Must live within a commutable distance to Waltham, MA. Job Purpose The New England Electric Major Projects team drives project management for major electric capital construction project investments, leading the clean energy transformation and significant portfolio growth. Projects include multi-year complex, large-scale Transmission-Line projects. The dedicated Lead Project Manager will oversee and drive major electric capital construction projects, ensuring safe delivery within budget, schedule and scope. Key Accountabilities * Lead strategic, critical, and complex electric capital construction...

National Grid About us Superpowered. Meaningful work. Human impact. A story we're proud to tell. This is what matters to us at National Grid. In a world of complexity and unanswered questions, there is one thing we're certain about: the power of our people. National Grid is hiring a Principal Project Manager (Electricity), Capital Project Delivery for Massachusetts. This is a Onsite Role - Must live within a commutable distance to Waltham, MA. Job Purpose The New England Electric Major Projects team drives project management for major electric capital constructionproject investments, leading the clean energy transformation and significant portfolio growth. Projects includemulti-year complex, large-scale Transmission-Line, Distribution-Line and Substation construction projects along with High Voltage DirectCurrent (HVDC) construction. The dedicated Principal Project Manager will oversee and drive major electric capitalconstruction projects, ensuring safe delivery...

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...

Alkermes, Inc. JOB DESCRIPTION Position Summary As a Senior Manager, Data Science within the INDIGO | AI Innovation Lab, you will play a hands-on role in developing analytical, traditional ML, and AI products and in supporting delivery of prioritized AI use cases on our roadmap. You will collaborate with business stakeholders on specific deliverables, maintain ownership of your work and ensure timely delivery of quality products. You will bring solid technical expertise and a strong sense of work ownership to a deeply collaborative setup, where AI innovation with strong business integration is paramount. The ideal candidate will have experience with data science and AI applications in the pharmaceutical or health-related industry. This role is based in our Waltham location and follows a hybrid office schedule. Responsibilities RESPONSIBILITIES Technical Development and Execution Design, develop, and deploy data science solutions including GenAI chatbot...

Alkermes, Inc. Responsibilities Govern owned QMS applications, including harmonization of processes across sites. Responsible for requirements authoring and ongoing maintenance by leading and facilitating meetings/workshops with Site Process Owners and Key Users (Business SMEs). Approve validation deliverables including initial implementation and operational changes. Change ownership, including initiating and managing change through completion. Maintain system in a validated state, including periodic user access review, ongoing change management, business administration, and deviations/CAPAs associated with QMS. Lead and manage user forums for ongoing requirements gathering, prioritization, and triaging of issues. Lead and manage ongoing meetings with the vendor/IT as necessary. Report status and issues to governance committees/senior leadership. Communicate milestones and planned changes to user community promoting use of QMS. Responsible for representing owned QMS...

Alkermes, Inc. Position: Director, Process Development Position Summary: An exciting opportunity for an experienced leader to join as a key member of the Pharmaceutical Development team with responsibility for process development activities at the Waltham site, ensuring delivery of robust processes that enable the consistent manufacture of high quality and life changing therapeutics for patients. This position is responsible for leading and empowering the Process Development Team in taking Alkermes' drug product candidates from formulation development through process development, scale-up, optimization, process characterization, clinical production, and technical transfer to the commercial manufacturing site. The successful candidate will thrive in a highly collaborative matrix team environment to drive critical decision-making and ensure the successful development of new drugs. Responsibilities and Requirements: Lead process development strategy for...

Alkermes, Inc. KEY AREAS OF JOB ACCOUNTABILITY: Provides process and technical leadership and assumes accountability for Quality System applications as assigned and will be ultimately responsible for ensuring that the quality system is compliant, and its operations are fit for intended use in accordance with applicable global procedures. Spearhead the improvement and management of DMS/QMS applications, as assigned, including harmonization of processes across sites. Responsible for defining the directional course of quality systems implementation and upgrade projects, ensuring comprehensive consultation and communication with impacted teams, individuals, and stakeholders. Responsible for requirements - authoring and on-going maintenance by leading and facilitating meeting/workshops with Site Process Owners and Key Users (Business SMEs) Lead development of and approve validation deliverables as a Global Process Owner as assigned- initial implementation and...

Alkermes, Inc. Job Title Senior System Analyst III - Clinical Manufacturing Suite Location Waltham, MA (Hybrid Office Schedule) Position Summary The IT Senior System Analyst III for Clinical Manufacturing Suite will lead all technology implementation, production support, and maintenance activities within the Clinical Manufacturing Suite, ensuring systems are reliable, secure, and compliant with GMP and GxP requirements. This position will be responsible for authoring and enforcing SOPs to meet GMP guidelines, onboarding and validating new equipment, maintaining compliance of existing systems, and driving the implementation of new IT GxP solutions such as Data Historian and LIMS. Partnering closely with CMC, quality, and regulatory teams, the IT Senior System Analyst III ensures alignment with FDA and global regulatory standards while fostering continuous improvement, operational excellence, and strong collaboration across the organization. The role requires deep...

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...

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! A fast-growing and acquisitive global public company is looking for a strong, experienced, and detail-oriented Senior Director of Finance reporting directly to the Vice President of FP&A. This represents an opportunity to work in a key finance leadership role with significant levels of executive visibility. This role must pay great attention to detail, deliver results, and operate cross-functionally in a rapidly changing environment. This role is a critical business...

CSL Position Description Summary The Senior Director, Business Strategy Lead for Research & Search is a key strategic and operational partner to CSL's global Research & Search function. This role ensures that critical business operations, including outsourcing, vendor management, budget oversight, resource allocation, and capital planning, align with CSL's corporate objectives and scientific priorities, enabling efficient research execution, scientific innovation, and sustainable global growth. Main Responsibilities & Accountabilities Strategic Leadership *Serve as a member of the Research & Search senior leadership team, contributing to vision, strategy, and operational excellence.*Lead change management initiatives to guide the global Research & Search function through significant organizational transformation, ensuring alignment, adoption, and sustained success across regions and teams.*Shape long-term operational strategies to enable...

CSL Responsible for the strategy, development, and optimization of digital platforms that support external innovation, business development, market analysis, and competitive intelligence. This role ensures the organization has a strategic edge by enabling timely, accurate, and actionable insights from external data sources, partnerships, and market signals. Main Responsibilities & Accountabilities *Lead the design and evolution of search and intelligence platforms that aggregate and analyze data from scientific literature, patents, clinical trials, market databases, and competitor pipelines*Collaborate with business development, R&D, strategy, and digital teams to define platform requirements, use cases, and key performance indicators (KPIs)*Integrate AI/ML, NLP, and semantic search technologies to enhance discovery, relevance, and insight generation*Manage external vendors and data providers, ensuring high-quality service delivery, innovation, and...

Revvity Summary: ViaCord, a Revvity Company, provides newborn stem cell preservation services for expectant families. Newborn stem cells are a valuable source of non-controversial stem cells ; the building blocks of our blood and immune systems. The value and benefits of stem cells found in umbilical cord blood are clear; cord blood collection saves lives today and medical researchers are exploring new uses for umbilical cord blood stem cellsfor tomorrow, including diabetes, heart disease, and stroke. Our Customer Service team is critical to the success of preserving the stem cells. They assist parents throughout the delivery process with any questions and also are responsible for ensuring the safe delivery of the stem cells to our laboratory facility. We are currently looking for enthusiastic people to join our growing team! This is a great opportunity for an individual to join an organization that provides growth opportunities for individuals looking to build a...

Alkermes, Inc. Associate Director of Information Security We are seeking a highly motivated, hands-on Information Security leader with strong, broad security expertise and proven experience in Data Loss Prevention (DLP) and Data Security Posture Management (DSPM), to join our team as an Associate Director of Information Security . This is a senior technical role that combines strategic leadership with technical execution to protect sensitive data across complex environments. In addition, this role will also oversee the Information Security Third-Party Risk Management (TPRM) program, ensuring robust security practices across internal and external environments. The Associate Director will lead a small team of security professionals and will report to the Director of Information Security. Responsibilities Essential Duties and Responsibilities Lead, mentor, and manage a team of security analysts, fostering a culture of continuous improvement, accountability, and...

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! About the Role: Repligen is a global, publicly traded company seeking a highly motivated, detail-oriented professional to join our growing Finance team. In this hybrid role, you will be required to work a minimum of two days per week in our Waltham, MA office. You will be responsible for coordinating with both internal and external partners to ensure the timely and accurate processing and payment of invoices while delivering exceptional service to our vendors and colleagues....

Alkermes, Inc. Regulatory Affairs Chemistry, Manufacturing, and Controls (CMC), plays a critical role in supporting a diverse portfolio of small molecule development programs and marketed products across multiple sites. Our team is driven by strategic excellence, collaborative spirit, and a commitment to delivering high-quality regulatory outcomes. We are seeking an experienced Associate Director, Regulatory Affairs CMC to serve as the Regulatory CMC Lead for a late-stage small molecule development program. This individual will be responsible for providing strategic regulatory direction and managing CMC related activities in close partnership with cross-functional development teams, ensuring compliance with global regulatory standards and alignment with internal program goals. This position is eligible for a hybrid workplace model, requiring work to be completed onsite at our Waltham, MA office. This role is not eligible for fully remote work. Key Responsibilities: Lead...

Alkermes, Inc. Reporting to the Vice President, Regulatory Affairs, Advertising Promotion & Labeling, the Director, Regulatory Affairs, Labeling will lead and facilitate the generation of new, and revision of, core labeling documents (Target Labeling, Company Core Data Sheet, US Prescribing Information, etc), in collaboration with cross-functional subject matter experts and Global Regulatory Leads (GRLs). The position requires management of multiple assigned products, including early and late-stage assets with differing levels of complexity. This position partners with other personnel including Regulatory, Clinical Development, Drug Safety, and Quality in support of development and maintenance of labeling content and contributes to health authority negotiations as necessary. Responsibilities Acts as point of contact for cross-functional teams on local and global labeling issues. Manages labeling development or approval. Preparation of updated Core Data Sheets and US...