- 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
- 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
- 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
- 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
- Sanofi Group (Cambridge, MA)
- …of combination products, design controls, design transfer, and manufacturing process validation + Manufacturing Program Lead of larger projects, proven ... GxP documentation and related Equipment Qualification and Process Validation of high throughput equipment. + Strong technical skills and familiarity… 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
- 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