- 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
- Prime Therapeutics (Boston, MA)
- …our passion and drives every decision we make. **Job Posting Title** Senior Compliance Analyst ( Regulatory Complaints & Inquires) - Remote **Job Description** ... The Regulatory Inquiry & Complaints Senior Compliance Analyst...adjust focus **Reporting Structure** + Reports to Sr Professional, Manager , Director or Senior Director in the Compliance… 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
- Pfizer (Cambridge, MA)
- …access to Pfizer medicines and vaccines. **What You Will Achieve** The Senior Manager , Global Regulatory Strategy for Oncology provides support to Director and ... teams and leads the development and preparation of regulatory documentation to regulatory authorities. As a Senior Manager , your advanced knowledge of the… 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 (Boston, 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
- 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
- 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
- Wondr Health (Boston, MA)
- … regulatory requirements. + Provide guidance for staff and leadership concerning regulatory compliance topics. + Work with Chief of Operations, Engineering ... **DESCRIPTION** **DEPARTMENT** **:** **Technology** **: IT** **& Security** **POSITION** **:** ** Manager ** **of Compliance and Security** **REPORTS TO:** **S**… more
- Textron (Wilmington, MA)
- …seeking an experienced Export Compliance professional to manage our expanding regulatory compliance and contractual obligations in our defense line of ... ** Manager , Import/Export Compliance \- New Orleans,...Compliance * Assist and mentor individual Domain Export/Import Compliance personnel in resolving import regulatory and… 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
- Teledyne (Billerica, MA)
- …**_Elkridge, MD_** **_Thousand Oaks, CA_** **_Billerica, MA_** **Job Summary:** The Licensing Manager , Trade Compliance works with a team of licensing analysts ... include aerospace and defense, factory automation, air and water quality environmental monitoring, electronics design and development, oceanographic research,… 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
- Rhythm Pharmaceuticals (Boston, MA)
- …strong analytical and report writing skills + Broad experience in GCP/GLP environments, regulatory compliance , and solid experience in GCP/GLP field auditing + ... and our tenacity to overcome barriers, together. Opportunity Overview The Clinical Quality Assurance Manager will oversee GCP activities across various areas… 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
- Sanofi Group (Framingham, MA)
- …+ Provide an assessment of supplier's quality in place with regards to material compliance , as well as regulatory of CAPA before communicating it to be the ... + **Job title:** Manager Quality Services (Third Party Audits),...TPM/CMO Operations, Affiliates, and other Stakeholders. + Responsible for compliance with Corporate and Divisional QA policies, procedures, standards,… more
- Takeda Pharmaceuticals (Lexington, MA)
- …potential risks + Ability to anticipate potential problems and risks related to quality expectations and regulatory compliance , formulate action plans, and ... Regulatory CMC and partnering with the Head of Quality Systems & Data Analytics, support the establishment of... Assurance including at least 3 years in GMP Quality or Compliance . + Six sigma/lean processing,… more