- Sanofi Group (Cambridge, MA)
- …+ Is responsible for the delivery quality, compliance with regulatory (Data Privacy, GxP , SOX, etc.) and cybersecurity requirements of the deployed solutions and the ... handover to operations teams. + .Coordinates the activities of project teams (internal and external resources), and potential third parties (suppliers, partners ), including eCommerce Delivery team + Monitors program & project KPIs + Defines and manages the… more
- C&W Services (Boston, MA)
- …CMMS. * Knowledge of Pharmaceutical and Biopharmaceutical Manufacturing Equipment, general GxP , and other applicable regulations including OSHA. * Experience with ... Job Hazard Analysis and Lock out Tag out. * Physical abilities include but not limited to, lifting objects up to 50lbs, able to be on feet all day, climb steps and ladders as required by job. PREFERRED QUALIFICATIONS: * Excellent verbal and written… more
- System One (Harvard, MA)
- …equivalent is preferred. + Advanced Level of relevant experience in a GMP, GCP, or GXP with at least 8 years focused on product quality. Preferred Active member of ... ASQ or ISPE. + Prior experience of QC equipment Qualification and some project management experience + Knowledge of biotech, bulk drug substance or finished product manufacturing, medical device analytical testing is highly desirable. + Extensive knowledge of… more
- Sanofi Group (Cambridge, MA)
- …management skills + Solid experience in Solution Architecture + Experience with GxP , HIPAA, and GDPR regulations and the ability to ensure compliance with ... these regulations in the design and implementation of IT solutions + Proven ability to translate functional requirements into technical/solution design, ensuring alignment with business goals and objectives + Excellent written and oral communication skills,… more
- Regeneron Pharmaceuticals (Cambridge, MA)
- …GMP experience is required. Experience with ERP, LIMS, QMS and other GxP -regulated computerized systems and analytical instruments is required. **This role is ... on-site in Cambridge, MA.** Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and… more
- Sanofi Group (Cambridge, MA)
- …challenges and requirements of delivering solutions in this space. + Knowledge of GxP , HIPAA, and GDPR regulations and the ability to ensure compliance with these ... regulations in the design and implementation of patient solutions. + Experience in encryption, data masking and data anonymization techniques + Detail-oriented, customer-driven, and able to work well across time zones on a global team. + Ability to work… more
- Cognizant (Boston, MA)
- …business systems analyst with a deep understanding of business processes under GxP , ISO, and regulatory compliance Knowledge of Mfg. Process Controls and Reporting ... program Awareness of Electronic Lot History Records using Camstar Software for Medical Device/ Pharma industries Implement and execute the shopfloor transaction using OpCenter Execution Discrete in Discrete manufacturing Industry Experienced in Camstar (V8.x)… more
- Takeda Pharmaceuticals (Boston, MA)
- …+ Ensure all products are developed and maintained in compliance with global regulations (eg, GxP , 21 CFR Part 11, ICH, EMA, FDA, PMDA) and Takeda's quality and risk ... management standards. + Work closely with architecture, engineering, quality, and data teams to ensure scalable and interoperable solutions across R&D. + Represent Development Technology product leadership in strategic governance forums, investment planning… more
- Takeda Pharmaceuticals (Lexington, MA)
- …+ Strong external network in innovative digital technologies + Expertise in GxP applications landscape + Strong expertise and experience in Data and Digital ... Technologies + Proven track record and expertise in defining and implementing digital strategies across the value chain (Industry 4.0/IoT) **More about us:** At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals… more
- Dana-Farber Cancer Institute (Boston, MA)
- …systems and operations (eg: laboratory, pharma) preferred. + Understanding of GxP system requirements and validations preferred. **KNOWLEDGE, SKILLS, AND ABILITIES ... REQUIRED:** + Deep knowledge and expertise of IT systems architecture, application development, and digital strategy within healthcare settings. + Strong leadership and project management skills, with the ability to manage complex transitions and drive… more