- Cognizant (Boston, MA)
- **About the role** As a ** Validation & Testing Lead in Life Sciences** , you will make an impact by driving the validation and testing strategy for Document ... to have to be considered:** + Deep knowledge of GxP regulations and global compliance standards (eg, 21 CFR...handling, CAPA management, and process harmonization. + Ability to lead cross-functional teams and manage validation deliverables… more
- Cognizant (Boston, MA)
- **About the role** As an **ALM** ** Validation Lead ** , you will make an impact by leading validation and testing initiatives across life sciences systems, ... and test strategies aligned with FDA, EMA, and GxP standards, supporting the transition to CSA. + Define...a focus on digital transformation and paperless execution. + Lead end-to-end validation and testing phases for… more
- Bristol Myers Squibb (Devens, MA)
- …qualification testing documents and associated testing deviations, providing escalations to CSV Lead as appropriate. + Review and approve validation lifecycle ... skilled and motivated Senior Engineer - IT Computer System Validation (CSV) to join our team at the Devens...reports for computer systems and software applications used in GxP environments. + Act as CSV Subject Matter Expert… more
- ThermoFisher Scientific (Lexington, MA)
- …electronic asset management. + Quality Systems & Administration (records management, validation document drafting- GXP ). + Assist with and coordinate tools ... our dedicated team at Unity Lab Services as a Lead Lab Support Specialist where you will provide seamless...Experience 3+ years' experience in a laboratory setting required. GxP experience required. Knowledge, Skills, Abilities + Become proficient… more
- Takeda Pharmaceuticals (Lexington, MA)
- … GxP Quality oversight of laboratory activities (method development, validation , release, stability) across modalities. + Ensure implementation and execution of ... to support analytical lifecycle management and regulatory submission readiness. + Lead key quality initiatives and investigations related to laboratory operations.… more
- Sanofi Group (Cambridge, MA)
- …guidance on risk management, control implementation, and action planning. + Lead risk assessments, quality assurance strategies, and validation activities ... **Job Title:** Digital Risk Advisory Lead **Location** : Cambridge, MA Morristown, NJ **About...years of experience in Quality Management, Computerized Systems compliance ( GxP , SOX, Data Privacy), or Information Technology in regulated… more
- Bristol Myers Squibb (Devens, MA)
- …instrumentation applications, PC hardware, and IT administrative tools within a GxP environment. Support would encompass various instrument types such as ... site which include laboratory and manufacturing areas. **Duties/Responsibilities** + Lead and support administration of quality and laboratory applications including… more
- Bristol Myers Squibb (Devens, MA)
- …MA will be responsible for providing Quality oversight of qualification and validation activities and change control for the startup and continuing operations of ... the Devens Cell Therapy Facility, including commissioning, qualification, and validation (CQV), computer systems validation (CSV) and process validation per… more
- Takeda Pharmaceuticals (Boston, MA)
- …**_Objective / Purpose:_** The Head of Design & Delivery, PharmSci will lead the global digital product strategy across Takeda's Pharmaceutical Sciences Digital Data ... product (PLM, R&D Search). Drug and Device Management Lab Validation . + Structure and resource product teams based on...user-centric across all business areas. + Build, upskill, and lead a high-performing global product management team. Foster a… more
- Bristol Myers Squibb (Devens, MA)
- …Bristol Myers Squibb is seeking an experienced and strategic Associate Director to lead the MES (Manufacturing Execution Systems) and Enterprise IT Systems at our ... implementation and maintenance of GMP-compliant digital solutions. **Key Responsibilities:** + Lead the design, deployment, and continuous improvement of MES and… more
- Cardinal Health (Boston, MA)
- …of a dataset's origin, transformations, and access for regulatory reporting. + Support the validation of computer systems used for GxP data to ensure they comply ... ensuring data is complete, accurate, consistent, and traceable. + Support and lead data integrity initiatives to ensure the accuracy, completeness, and reliability… more
- Bristol Myers Squibb (Cambridge, MA)
- …and support of LIMS and ELN applications. The role will also lead adoption of **GenAI and agentic-AI capabilities** (eg, Benchling Connect and MCP/Actions, ... and improve data quality, while meeting security, privacy, and GxP expectations If you seek a meaningful and impactful...LIMS, ELN, and other scientific applications. + **Testing and Validation ** : Oversee the development and execution of test… more
- ThermoFisher Scientific (Plainville, MA)
- …with confirmed competencies and strong character to join our team and help lead our organization into the future. **Location** Plainville, MA Position is Monday- ... Onboard new equipment with a cross functional team (procurement, validation ) How will you get there? **Required Skills** +...field required, with a minimum of 5 years of GXP or relevant experience + OR Higher Degree in… more
- ThermoFisher Scientific (Waltham, MA)
- …Proficiency with programming languages (C++, Python, or other) + Familiarity with IQ/OQ validation or GxP requirements is preferred + Solid understanding of ... solutions + Optimize the customer's workflows while delivering reliable results + Lead discussions as the domain guide and provide customers with system… more
- Bayer (Cambridge, MA)
- …trials, and overseeing digital capability enablement and operations. You will lead a cross-functional and global multimillion-dollar program to establish a ... execution for assigned technologies, including budget and resource distribution; + Lead a cross-functional and global multimillion-dollar program to establish a… more