- Fresenius Medical Center (Waltham, MA)
- …the collegial culture of a medium-sized company + Supporting the department in cross-site activities to monitor product quality and regulatory compliance ... + Experience in project management respectively change control process + Experience in regulatory affairs or in a quality environment, ideally in a… more
- ThermoFisher Scientific (Waltham, MA)
- …for developing strategies, systems, and processes to ensure a high level of regulatory compliance within LPE. Responsible for leading and developing the global ... registrations (eg, ISO, FDA, IVDD/IVDR, MDD/MDR), as well as product safety and regulatory compliance . Overseeing the regulatory submission to regulatory… more
- Point32Health (Canton, MA)
- …or Senior Manager of the department, the Compliance Program Manager III manages compliance programs, regulatory projects and initiatives with ... medium to large scale projects and initiatives, including management of compliance focused regulatory audits. Responsibilities include successful implementation… more
- Synchrony (Boston, MA)
- …internal cross functional teams responsible for executing initiatives around Part 370 Compliance and other regulatory reporting enhancements. This person must be ... owner who manages all aspects of the FDIC 370 compliance program including maintenance of data quality ...critical timelines + Manage cross functional, multi-year project and compliance plan(s) + Coordinate with Regulatory Reporting… more
- Dana-Farber Cancer Institute (Brookline, MA)
- …submits regulatory documents, and maintains records on assigned studies to ensure regulatory compliance with DFCI and DF/HCC policies as well as federal ... with amazing partners, including other Harvard Medical School-affiliated hospitals. + ** Regulatory Compliance ** + Prepares and submits all protocol applications,… more
- Prime Therapeutics (Boston, MA)
- …Office Suite **Preferred Qualifications** + Health insurance/PBM operations and/or regulatory compliance audit experience + Project management experience + ... to decrease risk for repeat audit findings + Perform quality reviews and analysis of audit deliverables to ensure... reviews and analysis of audit deliverables to ensure compliance with contractual and regulatory requirements. +… more
- Takeda Pharmaceuticals (Boston, MA)
- …: Cambridge, MA **About the role:** As a Senior Manager , GCP Compliance , you will provide quality oversight to clinical trial delivery quality ... aligned with Takeda's values and priorities. Reporting to the Head of Clinical Quality Compliance , you will contribute to the development and implementation of… more
- Fresenius Medical Center (Waltham, MA)
- …wide range of issues in creative ways. + Responsible for the preparation, compilation, quality check and delivery of regulatory submissions in both paper and/or ... AND SCOPE:** Assists in the support of the daily operational activities within Regulatory Affairs for the preparation of regulatory submissions required to… more
- Deloitte (Boston, MA)
- Are you a process-oriented thinker with experience in international tax compliance ? Do phrases like "best practices," "leading edge technology," and "maximum ... efficiency" pique your interest? Do you enjoy providing international compliance and process improvement advice to US and foreign...International Tax practice. What you'll do As a Tax Manager , you will work within an engagement team and… more
- Robert Half (Boston, MA)
- JOB REQUISITION Risk and Compliance - Healthcare - Senior Manager LOCATION BOSTON ADDITIONAL LOCATION(S) NEW YORK CITY, SAN FRANCISCO, SEATTLE JOB DESCRIPTION ... Need You Protiviti is looking for a Risk and Compliance Senior Manager to join our growing...of commonly used internal control frameworks, risk frameworks and regulatory / compliance methodologies. + Expertise of risk assessment… more
- Nanobiosym, Inc. (Cambridge, MA)
- …and requirements are below. The CLIA (Clinical Laboratory Improvement Amendments) Quality Manager will provide quality and compliance oversight to the ... top notch candidates to help the company scale up its operations. Nanobiosym is looking for a Quality Manager for its High-Complexity Testing CLIA LAB. The role… more
- Beth Israel Lahey Health (Woburn, MA)
- …to facilitate and support quality improvement efforts and compliance with regulatory requirements. The QI Manager will give guidance and direction to the ... **Job Description:** **What You'll Do** : The Home Health Quality Improvement (QI) Manager is responsible for... staff in finding solutions when process variations affect regulatory compliance or impede the revenue cycle.… more
- Cardinal Health (Boston, MA)
- …effective controls, achieve product quality and service goals, and maintain regulatory compliance + Serves as a liaison with Strategic Sourcing, Process ... Engineering, Design Quality , R&D, Medical Affairs, Quality Compliance and Governance, Regulatory , and other technical and service providing functions on… more
- Integra LifeSciences (Boston, MA)
- …pathways to advance patient outcomes and set new standards of care. The Senior Quality Compliance Specialist - Technical Writer will work with Boston quality ... Quality Management System under the direction of the Manager of Document Control and Training or Quality...to consensus. + Write, format, edit, review and proof quality system documentation and regulatory correspondence for… more
- Beth Israel Lahey Health (Boston, MA)
- …a critical role in ensuring adherence to quality standards, implementing quality improvement strategies, compliance with regulatory requirements, driving ... the direction of the Executive Director, Program Operations, the Manager of Quality , is responsible for the...quality program and service operations are conducted in compliance with applicable accreditation, statutory and regulatory … more
- North Coast Seafoods (Boston, MA)
- The Quality Control Manager is responsible for managing all the quality aspects of their production facility and ensuring that all seafood products are ... and Supervisors while working with production leadership to ensure company compliance , driven by regulatory requirements and customer specifications, are… more
- Integra LifeSciences (Boston, MA)
- …documentation control standards, document storage, and record retention as defined in the Quality Management System (QMS). The DCT Manager will work closely with ... cross functional leaders in teams such as IS, R&D, Regulatory Affairs, and Operations, to ensure specific quality...industry with strong concentration in QSR and ISO 13485 compliance and quality assurance preferred. **Skills/Knowledge:** +… more
- Sevita (Boston, MA)
- …mission-driven team and experience a career well lived. **Foster Care Quality Improvement Manager ** **Hybrid** **Office locations: Dedham, Lawrence, Worcester, ... acquisition diligence assessments and evaluation of prospective acquisitions + . Compliance + Develop and oversee quality and...with the State leadership team to develop policies in compliance with local regulatory standards and consistent… more
- Takeda Pharmaceuticals (Boston, MA)
- …global regulatory requirements for cell therapy products to ensure compliance . + Issue, review, and approve GMP documentation needed for internal manufacturing ... of my knowledge. **Job Description** **About the role:** As the Cell Therapy QA Manager , you will lead and execute QA operational activities at Takeda's internal GMP… more
- Elevance Health (Woburn, MA)
- …of any Elevance Health PulsePoint office * **some travel required** * The **Clinical Quality Program Manager ** is responsible for serving as a liaison with and ... plans and oversees the clinical quality improvement activities/projects to improve the quality of care for members. + Assures compliance with corporate QI… more