Clinical Quality Assurance Consultant

Viltis; San Francisco (CA); On-site; USD 100,000 - 160,000; Full time

Job summary

A leading biopharmaceutical company is seeking an experienced Clinical Quality Assurance Consultant to manage clinical quality initiatives. The role involves providing GCP guidance, leading audits, ensuring compliance, and collaborating across teams to uphold quality objectives. Ideal candidates will have a strong background in Life Sciences and significant experience in the pharmaceutical industry.

Qualifications

• Minimum of 10 years in Life Sciences quality and regulatory roles.
• Strong leadership and communication skills required.

Responsibilities

• Provide expert GCP guidance and training.
• Lead vendor and site audits for compliance.
• Develop quality compliance tools and metrics.

Skills

Leadership

Communication

GCP Compliance

Regulatory Compliance

eQMS Proficiency

Education

Bachelor's degree in a relevant field

Job description

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Quality

San Francisco, California Contract Jun 5, 2024

Summary

An experienced Clinical Quality Assurance Consultant (AD Level) is sought by a thriving biopharmaceutical organization to oversee and execute clinical quality initiatives. The role entails providing expert guidance on Good Clinical Practice (GCP), leading audits, ensuring regulatory compliance, and developing quality compliance plans.

Duties & Responsibilities

• Provide expert GCP guidance and training for internal teams and cross-functional collaborators.
• Lead vendor and site audits, ensuring inspection readiness for GCP and regulatory compliance.
• Develop and implement plans, tools, and metrics for clinical quality compliance.
• Facilitate team meetings and communications to ensure alignment on quality objectives.
• Undertake additional duties as required to support clinical quality initiatives.
  
  

Qualifications & Requirements

• Minimum of 10 years of Life Sciences quality and regulatory experience, with a focus on clinical quality within the pharmaceutical industry.
• Strong leadership skills, with the ability to build consensus across cross-functional teams.
• Excellent written, verbal, and interpersonal communication skills.
• Proficiency with electronic Quality Management Systems (eQMS) and Trial Master File (eTMF) systems.
• Bachelor's degree in a relevant field.
  
  

Location:

The position will be based onsite in the greater San Francisco Bay Area. Remote candidates may be considered, although a Bay Area location is strongly preferred.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Contract

Job function

• Job function

  Quality Assurance

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