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Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- Drive GCP Quality by maintaining quality line-of-sight for assigned clinical trial programs
- Ensure program and study level quality oversight
- Monitor asset/study quality and identify risks and trends
- Provide study team Inspection Readiness guidance and support
- Oversee study-level quality risk management activities
- Represent quality functional lines at integration workshops and operational workshops
Requirements
What you’ll need- A scientific or technical degree is preferred
- 10+ years of experience for BS or 7+ years for MS/MBA
- Strong, advanced knowledge of ICH GCP, clinical trial development, and operational GCP quality management disciplines
- Familiarity with relevant key therapeutic areas
- Advanced clinical trials experience, especially operational processes and/or systems
- Strong interpersonal skills
- Extensive knowledge of regulations for assessing GCP situations
- Quality related experience including knowledge in areas of quality assurance, CAPA management, deviation management, root cause analysis, audit and inspection processes
Benefits
Comp & perks- 401(k) plan with Pfizer Matching Contributions
- Additional Pfizer Retirement Savings Contribution
- Paid vacation
- Holiday and personal days
- Paid caregiver/parental and medical leave
- Health benefits including medical, prescription drug, dental and vision coverage
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
ICH GCPclinical trial developmentoperational GCP quality managementquality assuranceCAPA managementdeviation managementroot cause analysisaudit processesinspection processes
Soft Skills
interpersonal skills
