- Vera Therapeutics (Brisbane, CA)
- … GxP system. * Provide IT support for audits and inspections related to GxP systems, acting as the subject matter expert on technical architecture, validation ... Title: Job Title: Associate Director, GxP Systems Location: Brisbane, California About Us: Vera...role will play a pivotal part in supporting regulatory, compliance , and operational readiness for commercial launch. Working with… more
- CSL Behring (Kankakee, IL)
- …including planning, documentation, and implementation, specifically related to GxP processes. The position operates cross-functionally, gathering relevant data ... the M2U team, this individual will serve as a champion for quality, compliance , and operational excellence within the organization. This position reports directly to… more
- Gilead Sciences, Inc. (Foster City, CA)
- …for planning SOPs, Work Instructions, business policies and procedures to ensure GxP compliance . Influence cross-functional SOP content and review/approve as ... drugs and other co-meds for clinical studies, and, in comparator sourcing strategy. + Expert knowledge of the FDA GxP standards and regulatory guidance documents… more
- Novo Nordisk (Clayton, NC)
- …areas (aseptic, inspection, assembly, packaging, utilities & laboratories) required + Expert in GxP documentation practices required + Proficient in ... help us make what matters. The Position The IT Compliance Engineer is responsible for ensuring that IT ...+ Excellent oral & written communication skills required + Expert in DI gap analysis and remediation required +… more
- Sanofi Group (Cambridge, MA)
- …+ Compliance of Computerized systems (REMS, GDPR, PHI, PII, GxP ) + Patient Service/Healthcare experience desired **TRANSVERSAL SKILLS & COMPETENCIES (SOFT ... cloud technologies, batch data processing, real-time API integration, and regulatory compliance for pharmaceutical or healthcare systems. The role ensures that our… more
- Fresenius Medical Center (Knoxville, TN)
- …the department in cross-site activities to monitor product quality and regulatory compliance The internal Job Title is called **Global Product Center Manager (m/f/d) ... Fluids (Medicinal Products).** **Main Responsibilities:** + Support as regulatory expert development and new registration projects (Medicinal Products) + Project… more
- Kelly Services (Morris Plains, NJ)
- …Controller** to support GMP manufacturing operations by managing the full lifecycle of GxP and non- GxP documentation. The ideal candidate will have **hands-on ... This role is essential for maintaining documentation accuracy, regulatory compliance , and supporting cross-functional teams in a fast-paced, regulated manufacturing… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …be challenged and stretched while supported and developed by our diverse and expert team. We are a committed team of highly skilled Quality professionals dedicated ... reporting of assigned R&D groups / locations to ensure ongoing regulatory compliance , R&D quality and fit-for-purpose to both Gilead business needs and regulatory… more
- Kelly Services (Clayton, NC)
- …Quality systems + Documentation and data integrity + Laboratory operations + Regulatory compliance (GMP/ GxP ) + Budget planning and oversight + Employee relations ... + Provide expert guidance to manufacturing and regulatory departments on GxP -related matters. + Make informed, independent decisions within the defined scope of… more
- Catalent Pharma Solutions (Somerset, NJ)
- …with project teams, suppliers, site quality and IT teams acting as an expert on quality, regulatory, and compliance resource, bringing forth opportunities for ... periodic reviews, investigations, deviations and CAPAs relating to computerized GxP systems; Assure quality and regulatory compliance ...and Participate in internal and supplier audits as a compliance , IT and CSV subject matter expert … more
- CBRE (Tempe, AZ)
- …contract terms. **ESSENTIAL DUTIES AND RESPONSIBILITIES** Oversees the day-to-day Quality and Compliance Team operations at one account sites (may also support CBRE ... client specific). Monitors operations at the site and determines compliance status with regards to local and global regulatory...for the site. Has the responsibility to ensure all GxP service providers are qualified per the CBRE regulated… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …and business operations projects/initiatives that may include: + Tracking and monitoring compliance performance as related to non- GXP , GXP training ... to new hire orientation process + NS TAU Business Operations subject matter expert for Takeda systems and infrastructure, including but not limited to, PO creation… more
- Bristol Myers Squibb (Indianapolis, IN)
- …(US, EU, ICH etc.). Functional responsibilities include ensuring operational compliance with applicable procedures and batch records, providing real time ... and justification to stop/continue manufacturing. + Serve as a subject matter expert supporting others to navigate the RayzeBio quality management system including… more
- Charles River Laboratories (Mattawan, MI)
- …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 ... + Efficiently perform and document all procedures and results in compliance with applicable regulatory standards as applicable (protocols, methods, SOPs, etc.)… more
- Kedrion Biopharma (Melville, NY)
- …the compliance and reliability of computerized systems across our GxP operations, including manufacturing and laboratory environments. As a Subject Matter ... Expert (SME), you will lead validation efforts and support...**_Job Role and Responsibilities_** + _Lead validation projects for GxP systems-authoring and executing protocols and documentation (IQ/OQ/PQ, validation… more
- ManpowerGroup (Raleigh, NC)
- …calibration and maintenance of pharmaceutical equipment. + Strong understanding of regulatory compliance and GxP documentation. + Ability to work independently ... + Complete calibrations, qualifications, and preventive maintenance with accurate GxP documentation. + Develop and maintain strong client relationships through… more
- Cognizant (Washington, DC)
- …coach, and teach other technical team members on best practices/principles. + Ensure IT compliance (WICO, HIPAA, GXP , 21 CFR Part 11, Records Management, SOX, ... will be responsible for: + Act as subject matter expert on system design and architecture. + Solutioning and...with benefits delivered as committed required. + Experience in GxP systems, Computer System Validation, and consistent track record… more
- Charles River Laboratories (Mattawan, MI)
- …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 ... Efficiently perform and document all procedures, materials and results in compliance with applicable regulatory standards as applicable (protocols, methods, SOPs,… more
- Mallinckrodt Pharmaceuticals (St. Louis, MO)
- …cGMP compliance improvement and enhancement + Serve as the Subject Matter Expert during compliance audits + Study and improve various Quality processes ... Description Summary Manage key product and stability testing groups and compliance activities to achieve site and corporate objectives. Specifically, this position… more
- Terumo Neuro (Aliso Viejo, CA)
- …medical device industry to contribute to overall quality and regulatory compliance objectives. Encompass a broad spectrum of responsibilities including conducting ... reporting, root cause analysis investigation, and closure. Provide comprehensive compliance direction to clinical study teams and cross-functional partners; ensuring… more