Job Description

Clinical Quality Assurance Consultant
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.

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