Fully Remote Sr. Director, Clinical Quality Assurance (GCP)
A leading biotech company that is passionate about developing medicine to treat patients suffering with cancer is in search for a Sr.
Director of GCP Quality to lead the daily operations within the Clinical Quality department.
This company has multiple products across their pipeline from the pre-clinical stage, all the way to phase III offering stability and professional growth.
Key Responsibilities for the Sr.
Director of GCP Quality include:
Provides Clinical Quality Assurance oversight and oversees activities related to GCP Quality audits.
Developing and implementing processes, procedures, and systems to perform critical activities related to GCP Clinical Quality.
Leading the preparation for GCP Health Authority inspections.
Authoring and reviewing SOPs related to clinical trial activities.
Quality management of CROs, and other vendor services.
Assess GCP compliance issues.
Lead projects relating to Clinical Quality Assurance.
Ideal Qualifications for the Sr.
Director of GCP Quality include:
Bachelor's Degree in a scientific discipline.
Minimum of 10 years of experience in the Pharmaceutical/Biotech industry with a GCP, CQA focused role.
Strong CQA auditing and Heath Authority Inspections experience.
Strong knowledge of Standard Operating Procedures, CAPA processes, Quality Systems, ICH-GCP guidelines, and GCP regulations.
Expertise on Clinical Quality plans preferred.
Can confidently work independently and cross-functionally in a fast paced environment.
Strong leadership abilities and strong communications skills.
.
Estimated Salary: $20 to $28 per hour based on qualifications.
Director of GCP Quality to lead the daily operations within the Clinical Quality department.
This company has multiple products across their pipeline from the pre-clinical stage, all the way to phase III offering stability and professional growth.
Key Responsibilities for the Sr.
Director of GCP Quality include:
Provides Clinical Quality Assurance oversight and oversees activities related to GCP Quality audits.
Developing and implementing processes, procedures, and systems to perform critical activities related to GCP Clinical Quality.
Leading the preparation for GCP Health Authority inspections.
Authoring and reviewing SOPs related to clinical trial activities.
Quality management of CROs, and other vendor services.
Assess GCP compliance issues.
Lead projects relating to Clinical Quality Assurance.
Ideal Qualifications for the Sr.
Director of GCP Quality include:
Bachelor's Degree in a scientific discipline.
Minimum of 10 years of experience in the Pharmaceutical/Biotech industry with a GCP, CQA focused role.
Strong CQA auditing and Heath Authority Inspections experience.
Strong knowledge of Standard Operating Procedures, CAPA processes, Quality Systems, ICH-GCP guidelines, and GCP regulations.
Expertise on Clinical Quality plans preferred.
Can confidently work independently and cross-functionally in a fast paced environment.
Strong leadership abilities and strong communications skills.
.
Estimated Salary: $20 to $28 per hour based on qualifications.
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