- Takeda Pharmaceuticals (Cambridge, MA)
- …of commercial products and lifecycle management. + Collaborate closely with R&D, Quality , Regulatory , Procurement, and External Supply Teams to support seamless ... drug delivery devices. + Engage actively with Product Operations, Quality , Regulatory , and External CMO Operations &...and manufacturing. + Strong understanding of design control and regulatory requirements ( FDA , EMA, ISO, USP) for… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …regulatory requirements, operational efficiency, and alignment with corporate quality objectives. The position drives governance, technology enablement, and ... within the Learning Center of Excellence (CoE) under Global Quality . This role is responsible for overseeing the end-to-end...teams. + Strong understanding of R&D functions and the regulatory landscape (GxP, ICH, FDA , EMA, etc.).… more
- Element Materials Technology (Acton, MA)
- …pharmacies, and pharmaceutical companies in maintaining contamination control, product quality , and regulatory compliance-helping ensure safe, effective ... **Overview** Join Element's Acton laboratory, a cGMP-certified, FDA - and DEA-registered facility specializing in microbiology, environmental monitoring, and… more
- Parexel (Boston, MA)
- …of assigned clinical trials investigator sites to ensure patient safety and quality study execution in accordance with applicable prevailing laws, Good Clinical ... effective delivery of clinical trials (eg enrollment, database release), to safeguard the quality of investigator sites (eg patient safety, site quality and… more
- Bristol Myers Squibb (Devens, MA)
- …gained through direct support of commercial manufacturing. + Extensive knowledge of FDA /EMEA cGMPs and other global regulatory compliance guidelines (eg, ICH) ... development plans and assist in the creation of strategic objectives for regulatory filings. + Provides leadership and statistical SME support for complex data… more
- Fujifilm (Boston, MA)
- …(Service, Engineering, Integration, Customer Service, etc.). + Adheres to the Company's quality and regulatory compliance requirements and ensures that all job ... + Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements… more
- Astellas Pharma (Westborough, MA)
- …of GMP, SOPs and quality control processes, and strong knowledge of quality systems and regulatory requirements + Excels in a fast-paced team environment, ... Raw Materials will typically report to the Senior Manager, Quality Control Raw Materials. This role is expected to...relevant areas of 21CFR, ICH, USP, Ph. Eur. and FDA guidance documents as well as cGXPs in support… more
- Takeda Pharmaceuticals (Lexington, MA)
- …Collaborating with cross functional team members from mechanical, software, clinical, regulatory , and quality engineering disciplines. + Qualifying and managing ... + Leading and executing Human Factors strategy in compliance with regional regulatory guidance. + Driving and overseeing User Research strategy in compliance with… more
- Abbott (Springfield, MA)
- … requirements. * Complies with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, Company policies, operating procedures, ... of Abbott CRM products. Fully accountable for all performance metrics of quality , cost and delivery. Responsible for leading, facilitating, and directing the… more
- Lilly (Boston, MA)
- …studies from planning to close-out, ensuring adherence to timelines, budgets, and regulatory guidelines ( FDA , EMA, GCP, ICH) using a risk-based approach. ... operational plans for clinical studies, managing CROs and vendors to ensure high- quality execution. + Lead internal clinical trial team meetings, tracking key study… more