- J&J Family of Companies (Raritan, NJ)
- …User Access requests for all MedTech S/4 HANA ERP Systems with Good Practices ( GxP ) will be the primary area of focus. This includes reviewing, approving, and ... (thru Fiori app) and provide updates to the global ruleset for Good 'x' Practices ( GxP ) SOD rules + Participate in all GRC ruleset testing for ruleset updates on a… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …experience working with GVP processes and systems is required. + Proficient in GxP Auditing with a successful track record of leading pharmacovigilance audits. + ... ICH) and their application to cross-functional drug development. + Proficient in GxP Auditing with a successful track record of leading pharmacovigilance audits. +… more
- Bristol Myers Squibb (New Brunswick, NJ)
- …Vault, including validation, regression, and user acceptance testing. + Ensure alignment with GxP , 21 CFR Part 11, Annex 11, and other regulatory requirements. + ... capabilities in Quality, Manufacturing, or Compliance settings. + Thorough understanding of GxP , 21 CFR Part 11, HIPAA, and other relevant regulations. + Experience… more
- J&J Family of Companies (New Brunswick, NJ)
- …applications & technologies (QS, Office & productivity tools) + Compliance with the GxP , EHS and SOX requirements and guidelines, which are connected to the ... respected function + Define key performance indicators (KPIs) to monitor compliance with quality governance standards and provide regular reports to leadership. + Review and oversee the effectiveness of the Quality Management System (QMS) and its… more
- System One (Plainsboro, NJ)
- …such as: - Training Assignments and compliance in Veeva Vault - GCP/ GxP procedure distribution (internal and external) - Coordination and support of compliance ... meetings (agenda, slides, follow-up) - Safety vendor onboarding and access provisioning in Vault - Liaise with Safety Scientists, QA, Clinical, and Regulatory Affairs to ensure cohesive documentation and process alignment. Ref: #568-Clinical System One, and… more
- Sanofi Group (Morristown, NJ)
- …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
- Dr. Reddy's Laboratories (Princeton, NJ)
- …& productivity while ensuring that the deliverables are 21CFR Part 11, GAMP 5 and GxP compliant _Incumbent should be willing to work in person from our Princeton, NJ ... office_ **Qualifications** **Educational qualification:** Advanced scientific degree (MD, PhD, Pharm.D. or other) **Minimum work experience:** 10+ years in PV & Medical Affairs in the pharmaceutical industry **Skills & attributes:** + Understanding of North… more
- Robert Half Technology (Bridgewater, NJ)
- …or GCP, ensuring adherence to data privacy and compliance standards (eg, HIPAA, GxP ). + Collaborate with product, data, and platform engineering teams to integrate ... AI features into validated systems supporting clinical, quality, and manufacturing workflows. + Contribute to end-to-end MLOps: model experimentation, deployment pipelines, audit readiness, monitoring, and performance tuning. + Engineer full-stack applications… more
- J&J Family of Companies (Raritan, NJ)
- …management practices + Deep knowledge of the supply chain, including understanding GxP processes and data requirements + Great collaboration skills and ability to ... interpret end user needs + Superb communication and partner management skills. Ability to work multi-functionally with business, IT, and data teams + Analytical skills and strategic thinking **Preferred** + Proficiency in cloud-based data solution (Azure) +… more
- Robert Half Technology (Bridgewater, NJ)
- …is highly preferred. + Familiarity with validation and compliance processes (eg, GxP , 21 CFR Part 11) is a plus. + Excellent problem-solving, communication, ... and interpersonal skills. Preferred Skills: + Experience with ITIL practices and ticketing systems such as ServiceNow or Jira. + Project management experience and the ability to lead initiatives across multiple departments. + Exposure to cloud-based… more