5 jobs found in Waltham

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. 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...

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! We are seeking an experienced and driven IT Business Partner to represent our Manufacturing, Quality, Supply Chain, Product Development, and R&D organizations. As a Director of IT, you will play a key role in aligning technology initiatives with business goals, driving efficiency, and enabling innovation across the bioprocessing manufacturing and product development lifecycle.This position requires strong collaboration with business leaders and IT colleagues to evaluate,...

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! IT Manager, SOX & ITGC Compliance We are seeking an experienced IT Manager, SOX & ITGC Compliance to lead the design, implementation, and ongoing effectiveness of internal controls over financial reporting and key digital systems. This role drives the ITGC audit program, advises on risk mitigation strategies, and partners closely with Internal Audit, IT, Financial Reporting, and external auditors to strengthen Repligen's control environment. Responsibilities...

Revvity We are looking for a talented Senior B a ckend Software Engineer - Biologics/Tech Lead (Java, Vert.x, AWS) to join our Signals Software team, building our next generation cloud notebook application. You will be focused on the back-end design and development of our cloud notebook product, helping turn marketing requirements into an easy to use and elegant application designed for the scientific community. If you are looking to join an international team of talented engineers, designers, and product managers, and to contribute to delivering amazing, high impact, customer-focused features, this is a great opportunity. You Will: Collaborate with fellow team members on priorities, specifications, and feature implementation Craft well-documented, clean, and tested code Create secure, performant interfaces and services Build and maintain new, high-impact functionality into Signals Notebook Work with cloud services and technologies Basic...