Clinical Quality Partner
Roche
full-time
Posted on:
Location Type: Hybrid
Location: Tucson • Arizona, California, New Jersey • 🇺🇸 United States
Visit company websiteSalary
💰 $101,850 - $189,150 per year
Job Level
SeniorLead
Tech Stack
Google Cloud Platform
About the role
- Collaborate across the chapter, function, division, and enterprise on Roche global initiatives for consistent, high quality clinical evidence generation
- Collaborate with local stakeholders to support the mQMS clinical module to all applicable standards and regulations to ensure the protection of patient safety and rights
- Provide guidance and expertise on GCP including ISO 20916, IVDR, CFR 812, and other relevant clinical study regulations and standards
- Review and approve critical clinical evidence documentation and conduct internal and external audits
- Support audit activities (BIMO, NB) and preparedness
- Inspire and lead your clinical project teams to create transformative solutions, and to influence their prioritization and uptake in the wider organization
Requirements
- Bachelor’s degree and 8+ years of related experience (ideally within a regulated QMS) or 12+ years of related experience (ideally within a regulated QMS)
- Experience with quality support for clinical trials
- Specialist knowledge such as: ISO 20916, CFR 812, GCP, GCLP
- Previous audit support experience
- Strong clinical skills with a background in Clinical Operations
Benefits
- Discretionary annual bonus based on individual and Company performance
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
GCPISO 20916IVDRCFR 812clinical evidence generationclinical trialsaudit supportclinical operationsquality management systemGCLP
Soft skills
collaborationguidanceleadershipinfluencecommunicationteamworkproblem-solvingorganizational skillsstakeholder engagementinspiration