Clinical QA Manager

Redwood City, CA 94063

Posted: 01/22/2020 Employment Type: Direct Hire Industry: Clinical & Scientific Job Number: 17018

Job Description


 

Clinical QA Manager

 

What You’ ll Do
  • Assure that clinical studies/programs meet internal and regulatory requirements.
  • Review project timelines to ensure accurate and timely integration of quality activities.
  • Review and approve clinical documents, including Clinical Protocols and amendments; Investigator Brochure, Informed Consent.
  • Serve as GCP subject matter expert in support of internal and external clinical study activities.
  • Effectively identify, describe, and communicate issues in a timely manner and ensure issues are resolved to closure.
  • Assess Quality Assurance of Clinical studies of all programs including Clinical Investigator sites and CROs
  • Conduct GCP audits, monitor and track corrective and preventive actions resulting from audit findings.
  • Lead GCP quality training
  • Perform Quality Assurance audit of regulatory document clinical sections
  • Review and approve Clinical operations procedures
  • Other responsibilities as assigned

 

About You
  • BS degree required
  • Ten (10) years of direct experience in Biotechnology, Pharmaceutical or CRO (must have been part of the Quality, Compliance or Regulatory department)
  • Working knowledge and understanding of GCP regulations; US required, EU desired
  • Direct auditing experience (ability to travel approx. 20%)
  • Strong GCP experience
  • Ability to work effectively in a team environment with great organizational skills.
  • Possess effective interpersonal, verbal, and listening skills.
  • Ability to analyze and reconcile moderate to complex issues independently.
  • Must be an individual with proven initiative and demonstrated accountability in a fast paced environment with high degree of flexibility.
  • Proficient with computers and word processing software (Microsoft Office products).

  

 

 

Meet Your Recruiter

Jesse Ashworth

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