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Clinical Quality Assurance Consultant - Gcp

10+ years
Not Disclosed
10 Jan. 18, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Position: Clinical Quality Assurance Consultant - GCP
Location: Redwood City, CA 94043
Employment Type: Contract
Job Category: Quality and Compliance
Job Number: 616677
Is Job Remote?: Yes
Country: United States


Job Overview

The Clinical Quality Assurance Consultant will play a key role in providing compliance support for sponsored clinical trials, ensuring adherence to Standard Operating Procedures (SOPs), applicable regulatory requirements (FDA, EU, ICH, and country-specific), and current industry standards and practices.

Key Responsibilities

  • Collaborate with clinical functions (e.g., Clinical Operations, Clinical Development) to provide GCP compliance support.
  • Participate in clinical study execution teams (CSETs) to promote risk-based quality management and foster a culture of quality.
  • Perform quality reviews of clinical trial documents with a focus on compliance and risk management.
  • Assess and manage activities related to potential quality issues in GCP and clinical trial conduct, including investigations, root cause analysis, and CAPA planning.
  • Escalate identified issues to QA management when needed.
  • Assist with other GCP or GXP-related tasks as required.

Required Qualifications

  • Bachelor’s degree in a scientific or technical discipline.
  • A minimum of 10 years of experience in GCP Quality in the pharmaceutical or biotechnology industry.
  • Expertise in audit management, inspection readiness, Deviation/CAPA management, or related quality management system responsibilities.
  • Extensive knowledge of ICH GCP, FDA, EMA, and other relevant drug development regulations.
  • Strong verbal and written communication skills.
  • Ability to build and maintain positive relationships with GxP colleagues, internal stakeholders, and external partners.
  • Highly proficient in Microsoft Office (Word, Outlook, Excel, PowerPoint, Visio) and other computerized systems.

Additional Information

Planet Pharma is an equal opportunity employer committed to diversity, equity, and inclusion.