Associate Director, GCP QA & Clinical Compliance

Mirum Pharmaceuticals; Foster City (CA); On-site; USD 190,000 - 205,000; Full time

Job summary

Mirum Pharmaceuticals seeks an Associate Director of GCP/GVP/GLP-QA to support clinical studies. This role involves ensuring compliance with quality standards and overseeing GCP quality assurance activities.

The ideal candidate will possess a scientific Bachelor's degree and 10-12 years of experience in the pharmaceutical industry, including leadership in GCP Quality. The salary range offered is $190,000 to $205,000 USD, depending on experience and location.

Qualifications

• 10-12 years of experience in the pharmaceutical industry, including 5-10 years in GCP Quality.
• 5+ years supervising GCP Quality internal staff and/or external consultants.
• Knowledge of basic GVP, GCLP and GLP regulations.

Responsibilities

• Support clinical study programs as the GCP-QA representative.
• Manage activities involving GCP quality assurance.
• Conduct internal audits and provide quality oversight.

Skills

Experience with global contract research organizations (CROs)

Knowledge of GCP regulations

Quality oversight for vendor activities

Regulatory agency inspections support

Education

Bachelor’s Degree in a scientific discipline

Job description

Mirum Pharmaceuticals seeks an Associate Director of GCP/GVP/GLP-QA to support clinical studies. This role involves ensuring compliance with quality standards and overseeing GCP quality assurance activities.

The ideal candidate will possess a scientific Bachelor's degree and 10-12 years of experience in the pharmaceutical industry, including leadership in GCP Quality. The salary range offered is $190,000 to $205,000 USD, depending on experience and location.