- Bristol Myers Squibb (Devens, MA)
- …therapy manufacturing operations. + Ensure compliance with relevant regulatory requirements (GMP, GxP , 21 CFR Part 11) and internal standards for system design, ... Emerson Syncade) and enterprise IT architecture. + Strong understanding of GMP, GxP , and regulatory compliance in manufacturing environments. + Proven ability to… more
- Bristol Myers Squibb (Devens, MA)
- …**Knowledge and Skills:** + Comprehensive knowledge of Data Integrity guidance, GxP compliance, Software Development Life Cycle, and Good Documentation Practices. + ... Devices familiarity supporting benchtop instruments and applications within a GxP compliant manufacturing or laboratory setting. The starting compensation for… more
- Takeda Pharmaceuticals (Boston, MA)
- …across R&D while enabling compliance with regulatory standards such as HIPAA and GxP . + Implement and oversee fit for purpose data governance frameworks that focus ... frameworks to ensure compliance with global regulatory standards (eg, HIPAA, GxP ) while maintaining data accessibility and quality. + Collaboration and Innovation:… more
- Takeda Pharmaceuticals (Boston, MA)
- …analytics), ensuring scalability, interoperability, and compliance with global regulations (eg, GxP , 21 CFR Part 11). + Identify and evaluate emerging technologies ... in delivering enterprise-scale clinical technologies and digital solutions in a GxP -regulated environment. + Deep knowledge of the clinical development lifecycle and… more
- AbbVie (Worcester, MA)
- …Systems organization. This role is central to ensure that all data used in GxP systems are connected, accurate, secure and in full compliance with AbbVie's global ... data integrity. + Ensure adherence to regulatory standards (e, g FDA, GxP etc.) + Manage remediation efforts, utilizing risk management-based principles to identify… more
- Dana-Farber Cancer Institute (Boston, MA)
- …to SOPs. + Assist CMCF leadership to understand facility systems from a GXP and ISO perspective. + Collaborate with appropriate parties to ensure maintenance and ... identify the strengths and weaknesses of alternative solutions. + Knowledgeable about GXP requirements. At Dana-Farber Cancer Institute, we work every day to create… more
- Bristol Myers Squibb (Devens, MA)
- …technical data based on target audience. + Demonstrated experience working with GxP electronic systems such as Manufacturing Execution Systems (MES) for electronic ... batch records; Enterprise Resource Planning (ERP) such as SAP; laboratory information management systems; or Quality Management Systems such as TrackWise or Veeva. + Ability to lead change in a fast-paced environment with limited information and/or… more
- Takeda Pharmaceuticals (Boston, MA)
- …adopt new external data sources and technologies, while maintaining compliance with GxP regulations. + Demonstrated ability to leverage emerging data types and ... digital endpoints (eg, wearables, sensors, patient-reported outcomes) to enhance clinical trial insights and decision-making. + Strong strategic and operational leadership in scaling external data acquisition programs, mentoring cross-functional teams, and… more
- Bristol Myers Squibb (Cambridge, MA)
- …requirements and quality standards in the life sciences industry, such as GxP , FDA, and ISO standards. Preferred Qualifications: + Experience with LIMS and ... ELN platforms (eg Genedata, Dotmatics, Revvity, Sapio, Benchling, etc.). + Certification in Business Analysis (eg, CBAP, CCBA) or Project Management (eg, PMP). + Familiarity with data analytics and reporting tools. Why You Should Apply: Around the world, we… more
- Sanofi Group (Cambridge, MA)
- …in full compliance with Sanofi policies, with particular attention to GxP , privacy, and anti-kickback areas. **_Specific Responsibilities for Business Dynamics:_** ... **Focus Areas:** Understand treatment & market access dynamics (patient, prescriber, payer) **Data Assets:** APLD, Rx & Mx claims, lab, source-of-business, payer data attributes, payer mapping & hierarchies, pricing, formulary & UM criteria, SDOH **Business… more