Director, QA GCP - San Diego, CA | Biospace
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Director, QA GCP

Cidara Therapeutics

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Location:
San Diego, CA
Posted Date:
7/28/2017
Position Type:
Full time
Job Code:
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:

Job Description

Position Summary

This position will be responsible for all Quality Assurance GCP activities to ensure quality and compliance of Cidara sponsored clinical trials with respect to applicable GCP regulations (e.g., FDA, EU, country-specific), ICH GCP guidelines, Cidara Standard Operating Procedures (SOPs), and current industry standards and practices.  Activities will generally fall under the following areas: GCP QA audit program, Cidara quality systems, and internal/clinical study team support.  This position reports to the Vice President, Quality.

Responsibilities

Schedule, oversee and perform routine and non-routine quality assurance audits to include: clinical investigator sites, vendors, processes, systems and study documents to assure quality assurance compliance with regard to all internal procedures as well as regulatory guidelines.
Provide GCP QA oversight and support to internal staff.
Serve as the GCP QA representative on project teams.
Review and approve Clinical SOPs.
Develop and Implement Clinical QA SOPs.
Develop and implement detailed audit plans and yearly GCP audit schedules.
Ensure the timely and effective follow up of all identified or assigned quality issues.
Assist Clinical Operations in preparing investigational sites for regulatory inspections.
Conduct QA oversight of GCP protocols, ICFs, CSRs and other clinical trial specific documents as requested.
Direct or performs CSR audits.
Direct or perform eTMF audits.
Direct and/or delivers yarly GCP training for internal staff.

Requirements

Minimum Qualifications      

Bachelor’s Degree in a scientific discipline, a combination of relevant education and applicable job experience may be considered.
Minimum of 10 years in the Pharmaceutical industry with 5 years in GCP QA.
Solid understanding of GCP and ICH clinical requirements.
Experience with both domestic and international clinical studies.
Able to work independently with minimal direction.
Able to travel domestically and internationally approximately 25% of the time.
The content of this position description provides a summary of the general nature of the job and may include other duties as assumed or assigned.   The Company reserves the right to change this description at any time and require the employee to perform other tasks as required due to business needs.

Cidara Therapeutics is an E-Verify Company