- Nestle (Brisbane, CA)
- …and communication. + Act as a subject matter expert for the IT GxP Compliance Program. + Partner with QA to manage systems validation, periodic ... + Support Clinical Operations, Biometrics, and data management systems to ensure IT GxP compliance . GxP System Operations: + Oversee application… more
- Schrodinger (Cambridge, MA)
- We are looking to hire a **Director, GxP Quality Assurance and Compliance ** to join us in our mission to discover and develop drugs that improve human health ... will love this job:** + A strategic subject matter expert who's ready to partner with cross-functional teams as...and clinical teams **What you will do:** + Overall GxP Responsibilities: + Design, develop and implement overall … more
- CREO (Durham, NC)
- …change management practices and procedures. + Preferred qualifications + Familiarity with regulatory compliance standards, such as NIST, HIPAA, GDPR, GxP , etc. + ... The Principal IT Engineer Consultant will be responsible for assessing,...their performance and professional growth. + Provide timely and expert ad-hoc advisory services to address client needs. +… more
- Lilly (Indianapolis, IN)
- … Support** + Lead inspection readiness activities + Serve as a global compliance CGMP expert providing feedback in preparation for corporate audits, agency ... or regulatory affairs + Experience in Quality Assurance or GxP function + Strong compliance knowledge +...to meet multiple overlapping timelines. + Proficient in global IT tools such as Track Wise, Regulus, SharePoint. +… more
- Amgen (Washington, DC)
- …holds and e-discovery processes. + Work in conjunction with internal partners such as IT , Legal, Compliance , Quality, Privacy, and Audit to ensure a unified ... a career you can be proud of. Sr. Manager - Information Governance and Regulatory Compliance **Live** **What you will do** Let's do this. Let's change the world. In… more
- Verista (Boston, MA)
- …Operations areas. This position will be working closely with the operational functions, DTE ( IT ), and other GxP QA groups to provide oversight of computerized ... the implementation and use of computerized systems in all GxP areas * Participates in system implementation project teams...integrity * Identifies and escalates areas of risk or non- compliance to manager / leadership team * Participates in… more
- BeiGene (San Mateo, CA)
- …A key focus will be on strategic alignment, collaborating cross-functionally and cross- GxP to ensure that R&D Quality Management Systems (QMS) are optimized for ... both compliance and innovation. This role is pivotal in fostering...requirements. + Build and maintain strong cross-functional partnerships across GxP areas (GCP, GMP, GVP) to ensure alignment in… more
- Fresenius Medical Center (Lexington, MA)
- …compliant with regulatory requirements and meet the needs of our Quality and Compliance teams. They will be an experienced in managing external vendors, software ... Ensure cybersecurity controls and concerns are factored into any IT projects + Support with data gathering for business...team. + Ensure business continuity for the systems + Expert liaison for interface management on daily basis to… more
- J&J Family of Companies (Titusville, NJ)
- …control matters related to the program. The candidate is an SAP S/4 HANA and IT controls domain expert that will work in close collaboration with the TranSCend ... Lead the strategy for handling the different audit and IT SOX compliance activities + Understand and...and internal Johnson & Johnson policies such as IAPP, GxP , SOX, and GDPR + Provide assurance to program… more
- Bristol Myers Squibb (Bothell, WA)
- …FDA guidelines, and international standards to ensure lab operations remain in full compliance . + Provide expert guidance and support to ensure that all ... and approval of quality and validation related documentation and ensuring compliance during validation activities. This includes developing and delivering GMP… more
- Charles River Laboratories (Mattawan, MI)
- …of people across the globe. Whether your background is in life sciences, finance, IT , sales or another area, your skills will play an important role in the ... time of bioanalytical data. Staff are also knowledgeable in the application of GxP 's and applicable SOPs, along with adhering to study protocols to accurately… more
- AbbVie (North Chicago, IL)
- …regarding applicable Corporate and Divisional Policies, including code of conduct, safety, GxP compliance , and data security. Qualifications + Bachelor's Degree ... YouTube and LinkedIn. Job Description As a recognized multidisciplinary expert , drives functional performance by designing and implementing solutions aimed… more
- Kelly Services (Seattle, WA)
- …sequencers. + Enter and track data in a laboratory information database. + Ensure compliance with lab regulatory agencies ( GxP , FDA, ISO). + Exhibit clear and ... high-throughput sequencing assays on DNA libraries. + Perform protocols under compliance with regulatory agencies, model appropriate clinical, regulatory and safety… more
- Charles River Laboratories (Wilmington, MA)
- …of people across the globe. Whether your background is in life sciences, finance, IT , sales or another area, your skills will play an important role in the ... you can feel passionate about. **Job Summary** Serve as a Subject Matter Expert for mechanical utility systems and energy optimization. Work with all business units… more
- ManpowerGroup (Raleigh, NC)
- …cybersecurity threats and trends in the pharmaceutical industry. + Assist in regulatory compliance efforts, including HIPAA, GxP , and FDA requirements. If this ... we are committed to collaborating with and advocating for IT talent across all industries. We work with Cyber...Ethical Hacker (CEH)). + Experience with risk management and compliance in regulated industries. **What's in it for me?**… more
- Kelly Services (Houston, TX)
- …track clinical supply budgets and vendor invoicing to ensure financial transparency and compliance . + Other duties as assigned **Essential Details** + Full-time + Up ... international + Ensure all deliverables meet high-quality standards and adhere to GxP principles. **Key Requirements** + Bachelor's Degree or equivalent in a related… more
- AbbVie (Worcester, MA)
- …regarding applicable Corporate and Divisional Policies, including code of conduct, safety, GxP compliance , and data security. Qualifications + Bachelor's Degree ... group and help drive forward our Digital Transformation. The Data Architect is an expert in treatment of "context" of scientific data. On top of proper management of… more
- AbbVie (North Chicago, IL)
- …using Agile SDLC processes for development + Familiarity with data usage in compliance with GxP regulations preferred Additional Information Applicable only to ... and resolves client and BTS relationship issues. Manages and provides expert advice on the selection, design, justification, implementation and business use… more
- ICON Clinical Research (Whitesboro, NY)
- …direct supervision for supporting preclinical and clinical studies following applicable GXP guidelines.* * Supports data input into laboratory information management ... keeps current all training requirements. * Follows SOPs and relevant compliance regulations in regards to safety procedures, documentation, and scientific… more
- Amgen (Washington, DC)
- …environment, and knowledge of regulatory guidelines impacting clinical supplies (ie GxP , GDP guidelines, GMP guidelines, ICH guidelines, Clinical Trial Directive) + ... and update Standard Operations Procedures (SOP) and ensure SOP compliance . Identifies when controlled documents (eg, TRNQs, GDEs, SOPs)...based on audience + Serves as a subject matter expert on operational processes and systems within their area… more