- Danaher Corporation (Boston, MA)
- …driving innovation and excellence in the Biopharma sector. This position reports to the Director , Regulatory Affairs and is part of the Global Regulatory ... to secure product approvals. + Collaborate cross-functionally and globally with Clinical Affairs , R&D, QA , and Business Development to align regulatory plans… more
- Veterans Affairs, Veterans Health Administration (Leeds, MA)
- …Knowledge of policies and procedures of clinical laboratory testing. Knowledge of laboratory quality control and quality assurance principles. Knowledge of ... Quality and Compliance Agent, Regional Program Manager, Regional Director , Laboratory Director , or National Quality...theories that support sound, independent work. Knowledge of laboratory quality control and quality assurance … more
- Takeda Pharmaceuticals (Boston, MA)
- …preferred. + 7+ years experience in pharmaceutical industry, with 4 years in Regulatory Affairs , labeling or quality assurance /compliance. + Labeling SME - ... patients worldwide. As a key leader within Global Labeling Operations, the Director , Labeling Council and Regional Labeling, will provide direction and leadership… more
- State of Massachusetts (Boston, MA)
- …for licensure. Review is of carriers' operations, including utilization review, quality assurance , contracts with pharmacies and prescription drug manufacturers, ... of Insurance ("DOI"), an Agency within the Office of Consumer Affairs and Business Regulation, administers the Commonwealth's insurance consumer protection laws… more
- Takeda Pharmaceuticals (Boston, MA)
- …years of Quality /Compliance. + Advanced knowledge of clinical research, medical affairs activities and pharmaceutical commercial operations. + Experience ... spoken English, additional language skills a plus. **LICENSES/CERTIFICATIONS:** + MBA or Quality Assurance (eg, Lean Six Sigma) certification advantage **TRAVEL… more
- Takeda Pharmaceuticals (Boston, MA)
- …robust regulatory data governance and stewardship practices and ensure data quality assurance for authoritative regulatory data sources. Proactively drive ... involves guiding and mentoring a team of experts, driving regulatory data quality confidence, ensuring global system reach and adoption, and enhancing efficiency… more
- Takeda Pharmaceuticals (Lexington, MA)
- …Establish metrics to evaluate training effectiveness and implement continuous improvement **Clinical Quality Assurance & Compliance:** + Implement quality ... as clinical liaison to Global Device Team, including engineering, regulatory affairs , quality , and commercial functions + Coordinate interdepartmental… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …cross-functionally with analytical team members, process chemistry, formulation development, regulatory affairs , quality assurance , and other departments to ... **Associate Director , Small Molecule Analytical Development** + Lead and...lifecycle, including preclinical and clinical stages, regulatory requirements, and quality standards. **Competencies** **Accountability for Results -** Stay focused… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …cost reduction where appropriate. + Collaborate with cross-functional teams including R&D, Quality Assurance , Regulatory Affairs , and Operations to align ... **Position Overview:** The Senior Director , MSAT Biologics provides strategic and technical leadership...+ Ensure compliance with cGMP regulations and other relevant quality standards + Represent the MSAT function in interactions… more
- Candela Corporation (Marlborough, MA)
- ** Director , Design and Supplier Quality ** Requisition Number **2882** Location **US - Marlborough, MA** State/Territory **Massachusetts** **Company Overview:** ... Candela maintains contracted distributors in over 60 other countries. **General Summary** The Director , Design and Supplier Quality is responsible for NPI Design… more
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