- Bristol Myers Squibb (Devens, MA)
- …applications used in GxP environments. + Act as CSV Subject Matter Expert (SME) for computerized system related changes and associated IT /Automation projects ... seeking a highly skilled and motivated Senior Engineer - IT Computer System Validation (CSV) to join our team...work before regulatory agencies. + Duties may include internal compliance or efficiency improvement efforts within department. + Mentor… more
- Roche (South San Francisco, CA)
- …governance tools such as Collibra and Ataccma. + You have experience implementing GxP compliance frameworks and managing quality systems. + You demonstrate ... us Roche.** We are seeking an experienced **Digital Data Compliance Lead** to play a pivotal role in advancing...Pharma Technical (PT) Data Office, you will oversee digital GxP data governance, risk management, and spearhead critical elements… more
- Gilead Sciences, Inc. (Santa Monica, CA)
- …and Product Development functions. The ideal candidate will bring deep expertise in GxP digital systems, regulatory compliance , and agile innovation, along with ... maintain the Quality Management System (QMS) for digital health products and GxP computerized systems. * Ensure compliance with global regulatory requirements… more
- AbbVie (North Chicago, IL)
- …addition to equivalent experience listed above, if applicable). + Familiarity with regulatory compliance frameworks ( GxP , 21 CFR Part 11, ISO standards) and lab ... Tik Tok (https://www.tiktok.com/@abbvie) . Job Description We are seeking a skilled IT Technical Specialist with a background in leading projects related to Quality… more
- Bristol Myers Squibb (New Brunswick, NJ)
- …(tools) via collaboration and by authoring and/or reviewing procedures. + Support GXP Phase Appropriate QRM Content in Processes, procedures and learning material in ... digital QRM with key stakeholders. Support the testing and roll out of IT systems supporting QRM processes and data analytics. + Support process monitoring/adoption… more
- AbbVie (North Chicago, IL)
- …operating procedures. + Knowledge of pharmaceutical and healthcare business practices, including GxP , safety, and data security compliance . + Proven ability to ... Tik Tok (https://www.tiktok.com/@abbvie) . Job Description Serve as a technical expert and leader in laboratory operations for compound logistics, integrating… more
- Sanofi Group (Cambridge, MA)
- …leadership** in organizations with 10,000+ users + **Regulated industry experience** with GxP , SOX, HIPAA, or equivalent compliance frameworks + **AI/ML ... Architect cloud-native solutions optimized for AI/ML workloads with pharmaceutical compliance + Establish real-time data pipelines enabling AI-powered drug discovery… more
- Bristol Myers Squibb (Bothell, WA)
- …relevant work experience in pharmaceutical quality operations, quality assurance, quality systems, and/or IT compliance role. + Expertise with 21 CFR Part 11, EU ... **Key Responsibilities** + Serve as the site DI subject matter expert (SME) and promote/train/coach site staff on ALCOA+ principles and associated… more
- Roche (Oceanside, CA)
- …the ultimate steward of our data, ensuring all data activities are conducted in compliance with GxP , GDPR, and other relevant regulations, thereby building trust ... platforms to ensure state of the art data infrastructure, in close collaboration with IT and IT /OT teams. + Build, recruit, develop, and retain a world-class,… more
- AbbVie (North Chicago, IL)
- …optimize practices across ME&C. + Collaborate with cross-functional teams-including Operations, IT , Quality, Compliance , and Data Science-to identify & execute ... and lifecycle management. + Strong knowledge of pharmaceutical manufacturing, regulatory compliance (FDA, GxP ), and digital transformation. + Proven leadership… more
- Roche (Oceanside, CA)
- …Ensure data infrastructure and pipelines adhere to strict quality, security, and compliance standards (eg, GxP , data integrity, data privacy), collaborating ... of high-quality, FAIR data from diverse sources to data consumers, ensuring compliance , scalability, and future readiness for PT's ambitious digital agenda. **The… more
- Mallinckrodt Pharmaceuticals (St. Louis, MO)
- …objective of the position is to ensure product quality and site compliance to regulatory requirements. The Lead Validation Engineer interfaces with Manufacturing, ... Review and approval of validation documents including but not limited to: GxP Assessment, Risk Assessment, Part 11/Annex 11 Assessment, Data Integrity Assessments,… more
- Kelly Services (Seattle, WA)
- …implications of their work performance and when to escalate issues upward. + Ensures compliance with lab regulatory agencies ( GxP , FDA, ISO). + Keeps accurate ... team members on high-complexity molecular methods. + Performs protocols in compliance with regulatory agencies and models appropriate clinical, regulatory, and… more
- Bristol Myers Squibb (New Brunswick, NJ)
- …NCSVS. The role is critical to ensuring the integrity, security, and regulatory compliance of data systems used in support of drug development, nonclinical safety ... will have a strong background in laboratory informatics, regulatory compliance , and electronic data integrity principles. Operating within a...possess a strong information technology acumen and is an expert user of AI tools in support of the… more
- Kelly Services (Clayton, NC)
- …Familiarity with automation systems in regulated environments and understanding of GxP compliance , particularly Good Automated Manufacturing Practices (GAMP) As ... Systematic Problem Solving, process improvement, & project management + Operate within compliance with a Quality Mindset that focuses on risk management & mitigation… more
- NTT DATA North America (Highland Heights, KY)
- …seeking a highly experienced Laboratory Information Management System (LIMS) Subject Matter Expert (SME) with 10+ years of proven expertise in the implementation, ... The ideal candidate will serve as a key bridge between laboratory users, IT teams, and LIMS vendors, ensuring the system meets operational needs, regulatory… more
- Kelly Services (Carlsbad, CA)
- …Vendor Management programs. This individual contributor role reports to the Director of GxP Quality Systems and is instrumental in leading both internal and external ... management from onboarding and qualification through performance monitoring and compliance assessments. You'll collaborate with multidisciplinary teams on Change… more
- Sanofi Group (Waltham, MA)
- …the job** The Manager of Quality Operations ensures internal and external compliance to Sanofi's Standard Operating Procedures and that current industry standards ... related decision making. + Help establish and maintain phase-appropriate cGMP compliance for product manufacturing, testing and stability; leading the team to… more
- Kelly Services (Seattle, WA)
- …equipment such as **liquid handling robotics** and **DNA sequencers** . + Ensure compliance with regulatory agencies ( ** GxP , FDA, ISO, GMP, GCP, GLP** ... and **explain technical information** effectively. + **Regulatory responsibilities** in compliance with Good Clinical Practices (GCP), Good Laboratory Practices… more
- Bio-Techne (Minneapolis, MN)
- …footprint. This executive position serves as the primary bridge between IT and Operations/Supply Chain functions, driving digital transformation initiatives that ... counsel on technology investments and digital transformation initiatives + Represent IT 's interests in Operations leadership forums and vice versa, ensuring… more